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Nicotine
Overview
Active ingredients
Source: NDC DirectoryForms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Cholinergic Nicotinic Agonist [EPC] | EPC | All 61 members |
| Nicotine [CS] | CS | All 61 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 020076-001 | HABITROL | Film, Extended Release | NICOTINE | Discontinued | — | ||
| 020076-002 | HABITROL | Film, Extended Release | NICOTINE | Discontinued | — | ||
| 020076-003 | HABITROL | Film, Extended Release | NICOTINE | Discontinued | — | ||
| 020076-004 | HABITROL | FILM, EXTENDED RELEASE | NICOTINE | Over-the-counter | — | RLD | |
| 020076-005 | HABITROL | FILM, EXTENDED RELEASE | NICOTINE | Over-the-counter | — | RLD | |
| 020076-006 | HABITROL | FILM, EXTENDED RELEASE | NICOTINE | Over-the-counter | — | RLD RS |
Therapeutic equivalence
Source: Orange BookCodes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 51 | Labeling | Approved | January 2, 2019 | Standard |
| Supplement | 49 | Labeling | Approved | June 27, 2018 | Standard |
| Supplement | 45 | Labeling | Approved | July 23, 2017 | Standard |
| Supplement | 42 | Labeling | Approved | July 6, 2016 | Standard |
| Supplement | 43 | Labeling | Approved | July 5, 2016 | Standard |
| Supplement | 41 | Labeling | Approved | May 10, 2016 | Standard |
| Supplement | 40 | Manufacturing (CMC) | Approved | May 9, 2016 | Standard |
| Supplement | 39 | Manufacturing (CMC) | Approved | April 4, 2016 | Standard |
| Supplement | 38 | Manufacturing (CMC) | Approved | January 19, 2016 | Standard |
| Supplement | 37 | Manufacturing (CMC) | Approved | November 17, 2015 | Standard |
| Supplement | 36 | Labeling | Approved | July 25, 2014 | Standard |
| Supplement | 35 | Manufacturing (CMC) | Approved | May 16, 2013 | Standard |
| Supplement | 29 | Labeling | Approved | May 5, 2006 | Standard |
| Supplement | 28 | Labeling | Approved | November 22, 2005 | Standard |
| Supplement | 27 | Manufacturing (CMC) | Approved | October 21, 2004 | Standard |
| Supplement | 24 | Labeling | Approved | February 6, 2004 | Standard |
| Supplement | 25 | Labeling | Approved | January 21, 2004 | Standard |
| Supplement | 21 | Labeling | Approved | July 15, 2002 | Standard |
| Supplement | 20 | Labeling | Approved | July 12, 2002 | Standard |
| Supplement | 18 | Manufacturing (CMC) | Approved | November 7, 2000 | Standard |
| Supplement | 17 | Manufacturing (CMC) | Approved | January 31, 2000 | Standard |
| Supplement | 15 | Manufacturing (CMC) | Approved | December 3, 1999 | Standard |
| Supplement | 11 | Efficacy | Approved | November 12, 1999 | Standard |
| Supplement | 13 | Efficacy | Approved | January 7, 1999 | Standard |
| Supplement | 14 | Manufacturing (CMC) | Approved | October 29, 1998 | Standard |
| Supplement | 9 | Manufacturing (CMC) | Approved | July 24, 1996 | Standard |
| Supplement | 7 | Manufacturing (CMC) | Approved | February 8, 1996 | Standard |
| Supplement | 10 | Manufacturing (CMC) | Approved | October 6, 1995 | Standard |
| Supplement | 6 | Manufacturing (CMC) | Approved | October 6, 1994 | Standard |
| Supplement | 4 | Manufacturing (CMC) | Approved | July 21, 1992 | Standard |
| Supplement | 3 | Manufacturing (CMC) | Approved | July 21, 1992 | Standard |
| Supplement | 1 | Manufacturing (CMC) | Approved | January 6, 1992 | Standard |
| Original application | 1 | Type 3 - New Dosage Form | Approved | November 27, 1991 | Standard |
Review documents
- 0 · Supplement · February 1, 2019
- 0 · Supplement · January 4, 2019
- 0 · Supplement · July 6, 2018
- 0 · Supplement · July 6, 2018
- 0 · Supplement · July 26, 2017
- 0 · Supplement · July 25, 2017
- 0 · Supplement · July 18, 2016
- 0 · Supplement · July 8, 2016
- 0 · Supplement · July 7, 2016
- 0 · Supplement · July 7, 2016
- 0 · Supplement · June 17, 2016
- 0 · Supplement · May 16, 2016
- 0 · Supplement · July 29, 2014
- 0 · Supplement · July 28, 2014
- 0 · Supplement · May 16, 2006
- 0 · Supplement · November 30, 2005
- 0 · Supplement · October 29, 2004
- 0 · Supplement · March 3, 2004
- 0 · Supplement · January 22, 2004
- 0 · Supplement · July 15, 2002
- 0 · Supplement · July 15, 2002
- 0 · Supplement · July 12, 2002
- 0 · Supplement · July 12, 2002
- 0 · Supplement · November 12, 1999
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20250610). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingUse reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
Purpose
openFDA Drug LabelingPurpose Stop smoking aid
Dosage and Administration
openFDA Drug LabelingDirections • if you are under 18 years of age, ask a doctor before use • before using this product, read the enclosed User’s Guide for complete directions and other information • stop smoking completely when you begin using the patch • if you smoke more than 10 cigarettes per day, use according to the following 10 week schedule: STEP 1 STEP 2 STEP 3 Use one 21 mg patch/day Use one 14 mg patch/day Use one 7 mg patch/day Weeks 1-6 Weeks 7-8 Weeks 9-10 • if you smoke 10 or less cigarettes per day, do not use STEP 1 (21mg). Start with STEP 2 (14mg) , for 6 weeks, then STEP 3 (7mg) for 2 weeks and then stop. • steps 2 and 3 allow you to gradually reduce your level of nicotine. Completing the full program will increase your chances of quitting successfully. • apply one new patch every 24 hours on skin that is dry, clean and hairless. Save pouch for disposing of the patch after use. • remove backing from patch and immediately press onto skin. Hold for 10 seconds. • wash hands after applying or removing patch. Throw away the patch by folding sticky ends together. Replace in its pouch and discard. See enclosed User’s Guide for safety and handling. • you may wear the patch for 16 or 24 hours • if you crave cigarettes when you wake up, wear the patch for 24 hours • if you have vivid dreams or other sleep disturbances, you may remove the patch at bedtime and apply a new one in the morning • the used patch should be removed and a new one applied to a different skin site at the same time each day • do not wear more than one patch at a time • do not cut patch in half or into smaller pieces • do not leave patch on for more than 24 hours because it may irritate your skin and loses strength after 24 hours • stop using the patch at the end of 10 weeks. If you started with STEP 2 , stop using the patch at the end of 8 weeks. If you still feel the need to use the patch, talk to your doctor.
Warnings
openFDA Drug LabelingWarnings If you are pregnant or breast-feeding, only use this medicine on the advice of your health care provider. Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine. This medicine is believed to be safer than smoking. However, the risks to your child from this medicine are not fully known. Do Not Use • if you continue to smoke, chew tobacco, use snuff, or use a nicotine gum or other nicotine containing products Ask a doctor before use if you have • heart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate. • high blood pressure not controlled with medication. Nicotine can increase your blood pressure. • an allergy to adhesive tape or have skin problems because you are more likely to get rashes. Ask a doctor or pharmacist before use if you are • using a non-nicotine stop smoking drug • taking a prescription medicine for depression or asthma. Your prescription dose may need to be adjusted. When using this product • do not smoke even when not wearing the patch. The nicotine in your skin will still be entering your blood stream for several hours after you take off the patch. • if you have vivid dreams or other sleep disturbances remove this patch at bedtime Stop use and ask a doctor if • skin redness caused by the patch does not go away after four days, or if your skin swells, or you get a rash • irregular heartbeat or palpitations occur • you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, weakness and rapid heartbeat Keep out of reach of children and pets. Used patches have enough nicotine to poison children and pets. If swallowed, get medical help or contact a Poison Control Center right away. Dispose of the used patches by folding sticky ends together. Replace in pouch and discard.
Do Not Use
openFDA Drug LabelingDo Not Use • if you continue to smoke, chew tobacco, use snuff, or use a nicotine gum or other nicotine containing products
Ask a Doctor
openFDA Drug LabelingAsk a doctor before use if you have • heart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate. • high blood pressure not controlled with medication. Nicotine can increase your blood pressure. • an allergy to adhesive tape or have skin problems because you are more likely to get rashes • stomach ulcers or diabetes • history of seizures
Stop Use
openFDA Drug LabelingStop use and ask a doctor if • skin redness caused by the patch does not go away after four days, or if your skin swells, or you get a rash • irregular heartbeat or palpitations occur • you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, weakness and rapid heartbeat • you have symptoms of an allergic reaction (such as difficulty breathing or rash)
Active Ingredient
openFDA Drug LabelingActive ingredient Step 1 (in each patch) Nicotine, 21 mg delivered over 24 hours
Active ingredient Step 2 (in each patch) Nicotine, 14 mg delivered over 24 hours
Active ingredient Step 3 (in each patch) Nicotine, 7 mg delivered over 24 hours
How Supplied / Storage and Handling
openFDA Drug LabelingHOW SUPPLIED Product: 50090-6383 NDC: 50090-6383-0 24 h in a PATCH / 14 in a CARTON
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: NICOTINE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 50090-6383-0 | 50090-6383 | A-S Medication Solutions | 14 PATCH in 1 CARTON (50090-6383-0) / 24 h in 1 PATCH | February 28, 2023 |
| 59779-443-74 | 59779-443 | CVS Pharmacy | 14 PATCH in 1 CARTON (59779-443-74) / 24 h in 1 PATCH | August 10, 2015 |
| 59779-445-74 | 59779-445 | CVS Pharmacy | 14 PATCH in 1 CARTON (59779-445-74) / 24 h in 1 PATCH | August 10, 2015 |
| 59779-448-02 | 59779-448 | CVS Pharmacy | 2 POUCH in 1 CARTON (59779-448-02) / 24 h in 1 POUCH | October 18, 2016 |
| 59779-448-70 | 59779-448 | CVS Pharmacy | 7 PATCH in 1 CARTON (59779-448-70) / 24 h in 1 PATCH | August 10, 2015 |
| 59779-448-74 | 59779-448 | CVS Pharmacy | 14 PATCH in 1 CARTON (59779-448-74) / 24 h in 1 PATCH | August 10, 2015 |
| 63868-734-14 | 63868-734 | Chain Drug Marketing Association INC | 14 PATCH in 1 CARTON (63868-734-14) / 24 h in 1 PATCH | October 31, 2020 |
| 63868-735-14 | 63868-735 | Chain Drug Marketing Association INC | 14 PATCH in 1 CARTON (63868-735-14) / 24 h in 1 PATCH | October 31, 2020 |
| 55910-313-02 | 55910-313 | DOLGENCORP, LLC | 2 PATCH in 1 CARTON (55910-313-02) / 24 h in 1 PATCH | June 15, 2019 |
| 43598-446-70 | 43598-446 | Dr. Reddy's Laboratories Inc. | 7 PATCH in 1 CARTON (43598-446-70) / 24 h in 1 PATCH | March 31, 2019 |
| 43598-446-74 | 43598-446 | Dr. Reddy's Laboratories Inc. | 14 PATCH in 1 CARTON (43598-446-74) / 24 h in 1 PATCH | March 31, 2019 |
| 43598-447-70 | 43598-447 | Dr. Reddy's Laboratories Inc. | 7 PATCH in 1 CARTON (43598-447-70) / 24 h in 1 PATCH | March 31, 2019 |
| 43598-447-74 | 43598-447 | Dr. Reddy's Laboratories Inc. | 14 PATCH in 1 CARTON (43598-447-74) / 24 h in 1 PATCH | April 5, 2019 |
| 43598-448-28 | 43598-448 | Dr. Reddy's Laboratories Inc. | 28 PATCH in 1 CARTON (43598-448-28) / 24 h in 1 PATCH | March 31, 2019 |
| 43598-448-70 | 43598-448 | Dr. Reddy's Laboratories Inc. | 7 PATCH in 1 CARTON (43598-448-70) / 24 h in 1 PATCH | March 31, 2019 |
| 43598-448-74 | 43598-448 | Dr. Reddy's Laboratories Inc. | 14 PATCH in 1 CARTON (43598-448-74) / 24 h in 1 PATCH | March 31, 2019 |
| 60429-443-14 | 60429-443 | Golden State Medical Supply, Inc. | 14 PATCH in 1 CARTON (60429-443-14) / 24 h in 1 PATCH | September 23, 2015 |
| 60429-444-14 | 60429-444 | Golden State Medical Supply, Inc. | 14 PATCH in 1 CARTON (60429-444-14) / 24 h in 1 PATCH | September 23, 2015 |
| 60429-445-14 | 60429-445 | Golden State Medical Supply, Inc. | 14 PATCH in 1 CARTON (60429-445-14) / 24 h in 1 PATCH | September 23, 2015 |
| 58316-006-01 | 58316-006 | Haleon US Holdings LLC | 6300 POUCH in 1 CARTON (58316-006-01) / 1 PATCH in 1 POUCH / 24 h in 1 PATCH | June 1, 2022 |
| 58316-007-01 | 58316-007 | Haleon US Holdings LLC | 6300 POUCH in 1 CARTON (58316-007-01) / 1 PATCH in 1 POUCH / 24 h in 1 PATCH | June 1, 2022 |
| 58316-008-01 | 58316-008 | Haleon US Holdings LLC | 6300 POUCH in 1 PACKAGE (58316-008-01) / 1 PATCH in 1 POUCH / 24 h in 1 PATCH | June 1, 2022 |
| 58316-009-02 | 58316-009 | Haleon US Holdings LLC | 6300 POUCH in 1 CARTON (58316-009-02) / 1 PATCH in 1 POUCH / 24 h in 1 PATCH | June 1, 2022 |
| 58316-010-02 | 58316-010 | Haleon US Holdings LLC | 6300 POUCH in 1 CARTON (58316-010-02) / 1 PATCH in 1 POUCH / 24 h in 1 PATCH | June 1, 2022 |
| 58316-011-02 | 58316-011 | Haleon US Holdings LLC | 6300 POUCH in 1 PACKAGE (58316-011-02) / 1 PATCH in 1 POUCH / 24 h in 1 PATCH | June 1, 2022 |
| 11822-4973-0 | 11822-4973 | Rite Aid Corporation | 14 PATCH in 1 CARTON (11822-4973-0) / 24 h in 1 PATCH | May 14, 2015 |
| 11822-4974-0 | 11822-4974 | Rite Aid Corporation | 14 PATCH in 1 CARTON (11822-4974-0) / 24 h in 1 PATCH | May 14, 2015 |
| 11822-4975-0 | 11822-4975 | Rite Aid Corporation | 7 PATCH in 1 CARTON (11822-4975-0) / 24 h in 1 PATCH | May 14, 2015 |
| 11822-4975-1 | 11822-4975 | Rite Aid Corporation | 14 PATCH in 1 CARTON (11822-4975-1) / 24 h in 1 PATCH | May 14, 2015 |
| 11822-4975-2 | 11822-4975 | Rite Aid Corporation | 2 PATCH in 1 CARTON (11822-4975-2) / 24 h in 1 PATCH | May 14, 2015 |
| 0536-1106-88 | 0536-1106 | Rugby Laboratories | 14 PATCH in 1 CARTON (0536-1106-88) / 24 h in 1 PATCH | April 1, 2016 |
| 0536-1107-88 | 0536-1107 | Rugby Laboratories | 14 PATCH in 1 CARTON (0536-1107-88) / 24 h in 1 PATCH | April 1, 2016 |
| 0536-1108-88 | 0536-1108 | Rugby Laboratories | 14 PATCH in 1 CARTON (0536-1108-88) / 24 h in 1 PATCH | April 1, 2016 |
| 70677-1264-1 | 70677-1264 | Strategic Sourcing Services LLC | 14 PATCH in 1 CARTON (70677-1264-1) / 24 h in 1 PATCH | January 10, 2025 |
| 70677-1265-1 | 70677-1265 | Strategic Sourcing Services LLC | 14 PATCH in 1 CARTON (70677-1265-1) / 24 h in 1 PATCH | January 10, 2025 |
| 70677-1266-1 | 70677-1266 | Strategic Sourcing Services LLC | 14 PATCH in 1 CARTON (70677-1266-1) / 24 h in 1 PATCH | January 10, 2025 |
| 70677-1266-2 | 70677-1266 | Strategic Sourcing Services LLC | 28 PATCH in 1 CARTON (70677-1266-2) / 24 h in 1 PATCH | January 10, 2025 |
| 11673-194-02 | 11673-194 | Target Corporation | 14 PATCH in 1 CARTON (11673-194-02) / 24 h in 1 PATCH | February 16, 2000 |
| 11673-195-02 | 11673-195 | Target Corporation | 14 PATCH in 1 CARTON (11673-195-02) / 24 h in 1 PATCH | February 16, 2000 |
| 11673-196-02 | 11673-196 | Target Corporation | 14 PATCH in 1 CARTON (11673-196-02) / 24 h in 1 PATCH | February 16, 2000 |
| 59450-001-74 | 59450-001 | The Kroger Co. | 14 PATCH in 1 CARTON (59450-001-74) / 24 h in 1 PATCH | August 25, 2015 |
| 59450-002-74 | 59450-002 | The Kroger Co. | 14 PATCH in 1 CARTON (59450-002-74) / 24 h in 1 PATCH | August 25, 2015 |
| 59450-003-74 | 59450-003 | The Kroger Co. | 14 PATCH in 1 CARTON (59450-003-74) / 24 h in 1 PATCH | August 25, 2015 |
| 49035-194-01 | 49035-194 | Wal-Mart Stores Inc | 7 PATCH in 1 CARTON (49035-194-01) / 24 h in 1 PATCH | October 19, 2010 |
| 49035-194-02 | 49035-194 | Wal-Mart Stores Inc | 14 PATCH in 1 CARTON (49035-194-02) / 24 h in 1 PATCH | October 19, 2010 |
| 49035-195-02 | 49035-195 | Wal-Mart Stores Inc | 14 PATCH in 1 CARTON (49035-195-02) / 24 h in 1 PATCH | October 19, 2010 |
| 49035-196-02 | 49035-196 | Wal-Mart Stores Inc | 14 PATCH in 1 CARTON (49035-196-02) / 24 h in 1 PATCH | October 19, 2010 |
| 0363-0451-74 | 0363-0451 | Walgreens Company | 14 PATCH in 1 CARTON (0363-0451-74) / 24 h in 1 PATCH | September 1, 2015 |
| 0363-0455-70 | 0363-0455 | Walgreens Company | 7 PATCH in 1 CARTON (0363-0455-70) / 24 h in 1 PATCH | September 1, 2015 |
| 0363-0455-74 | 0363-0455 | Walgreens Company | 14 PATCH in 1 CARTON (0363-0455-74) / 24 h in 1 PATCH | September 1, 2015 |
| 0363-0457-74 | 0363-0457 | Walgreens Company | 14 PATCH in 1 CARTON (0363-0457-74) / 24 h in 1 PATCH | September 1, 2015 |
| 50090-6383 | 50090-6383 | A-S Medication Solutions | — | May 14, 2015 |
| 59779-443 | 59779-443 | CVS Pharmacy | — | August 6, 2015 |
| 59779-445 | 59779-445 | CVS Pharmacy | — | August 6, 2015 |
| 59779-448 | 59779-448 | CVS Pharmacy | — | August 6, 2015 |
| 63868-734 | 63868-734 | Chain Drug Marketing Association INC | — | October 31, 2020 |
| 63868-735 | 63868-735 | Chain Drug Marketing Association INC | — | October 31, 2020 |
| 55910-313 | 55910-313 | DOLGENCORP, LLC | — | June 15, 2019 |
| 43598-446 | 43598-446 | Dr. Reddy's Laboratories Inc. | — | May 14, 2015 |
| 43598-447 | 43598-447 | Dr. Reddy's Laboratories Inc. | — | May 14, 2015 |
| 43598-448 | 43598-448 | Dr. Reddy's Laboratories Inc. | — | May 14, 2015 |
| 60429-443 | 60429-443 | Golden State Medical Supply, Inc. | — | November 12, 1999 |
| 60429-444 | 60429-444 | Golden State Medical Supply, Inc. | — | November 12, 1999 |
| 60429-445 | 60429-445 | Golden State Medical Supply, Inc. | — | November 12, 1999 |
| 58316-006 | 58316-006 | Haleon US Holdings LLC | — | June 1, 2022 |
| 58316-007 | 58316-007 | Haleon US Holdings LLC | — | June 1, 2022 |
| 58316-008 | 58316-008 | Haleon US Holdings LLC | — | June 1, 2022 |
| 58316-009 | 58316-009 | Haleon US Holdings LLC | — | June 1, 2022 |
| 58316-010 | 58316-010 | Haleon US Holdings LLC | — | June 1, 2022 |
| 58316-011 | 58316-011 | Haleon US Holdings LLC | — | June 1, 2022 |
| 11822-4973 | 11822-4973 | Rite Aid Corporation | — | May 14, 2015 |
| 11822-4974 | 11822-4974 | Rite Aid Corporation | — | May 14, 2015 |
| 11822-4975 | 11822-4975 | Rite Aid Corporation | — | May 14, 2015 |
| 0536-1106 | 0536-1106 | Rugby Laboratories | — | April 1, 2016 |
| 0536-1107 | 0536-1107 | Rugby Laboratories | — | April 1, 2016 |
| 0536-1108 | 0536-1108 | Rugby Laboratories | — | April 1, 2016 |
| 68196-194 | 68196-194 | Sam's West Inc | — | March 2, 2012 |
| 70677-1264 | 70677-1264 | Strategic Sourcing Services LLC | — | November 2, 2015 |
| 70677-1265 | 70677-1265 | Strategic Sourcing Services LLC | — | November 2, 2015 |
| 70677-1266 | 70677-1266 | Strategic Sourcing Services LLC | — | November 2, 2015 |
| 11673-194 | 11673-194 | Target Corporation | — | February 16, 2000 |
| 11673-195 | 11673-195 | Target Corporation | — | February 16, 2000 |
| 11673-196 | 11673-196 | Target Corporation | — | February 16, 2000 |
| 59450-001 | 59450-001 | The Kroger Co. | — | August 25, 2015 |
| 59450-002 | 59450-002 | The Kroger Co. | — | August 25, 2015 |
| 59450-003 | 59450-003 | The Kroger Co. | — | August 25, 2015 |
| 49035-194 | 49035-194 | Wal-Mart Stores Inc | — | October 19, 2010 |
| 49035-195 | 49035-195 | Wal-Mart Stores Inc | — | October 19, 2010 |
| 49035-196 | 49035-196 | Wal-Mart Stores Inc | — | October 19, 2010 |
| 0363-0451 | 0363-0451 | Walgreens Company | — | September 1, 2015 |
| 0363-0455 | 0363-0455 | Walgreens Company | — | September 1, 2015 |
| 0363-0457 | 0363-0457 | Walgreens Company | — | September 1, 2015 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
Generated September 25, 2026 · 12 sections on this page.