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Guaifenesin and Dextromethorphan HBr
Overview
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Dextromethorphan Hydrobromide | 1 kg/kg | 1094538 | View |
| Dextromethorphan Hydrobromide | 30 mg/1 | 1094538 | View |
| Dextromethorphan Hydrobromide | 60 mg/1 | 1094538 | View |
| Guaifenesin | 1 kg/kg | 359601 | View |
| Guaifenesin | 1200 mg/1 | 359601 | View |
| Guaifenesin | 600 mg/1 | 359601 | View |
Forms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Decreased Respiratory Secretion Viscosity [PE] | PE | All 52 members |
| Expectorant [EPC] | EPC | All 48 members |
| Increased Respiratory Secretions [PE] | PE | All 48 members |
| Sigma-1 Agonist [EPC] | EPC | All 44 members |
| Sigma-1 Receptor Agonists [MoA] | MoA | All 44 members |
| Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC] | EPC | All 44 members |
| Uncompetitive NMDA Receptor Antagonists [MoA] | MoA | All 44 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 206941-001 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | TABLET, EXTENDED RELEASE | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN | Over-the-counter | — | ||
| 206941-002 | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | TABLET, EXTENDED RELEASE | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN | Over-the-counter | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Original application | 1 | Approved | March 17, 2017 | Standard |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20251130). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingUses • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive • temporarily relieves: • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants • the intensity of coughing • the impulse to cough to help you get to sleep
Purpose
openFDA Drug LabelingActive ingredients (in each extended-release tablet) Purposes Dextromethorphan HBr 60 mg Cough suppressant Guaifenesin 1,200 mg Expectorant
Dosage and Administration
openFDA Drug LabelingDirections do not crush, chew, or break extended-release tablet take with a full glass of water this product can be administered without regard for timing of meals children under 12 years of age: do not use For 600 mg/30 mg: adults and children 12 years and older: 1 or 2 extended-release tablets every 12 hours; not more than 4 extended-release tablets in 24 hours. For 1200 mg/60 mg: adults and children 12 years and older: 1 extended-release tablet every 12 hours; not more than 2 extended-release tablets in 24 hours.
Warnings
openFDA Drug LabelingWarnings Do not use • for children under 12 years of age • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema • cough accompanied by too much phlegm (mucus) When using this product • Do not use more than directed Stop use and ask a doctor if • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness. Pregnancy or Breast Feeding If pregnant or breast-feeding, ask a health professional before use. Keep Out of Reach of Children In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Do Not Use
openFDA Drug LabelingDo not use for children under 12 years of age if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a Doctor
openFDA Drug LabelingAsk a doctor before use if you have • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema • cough accompanied by too much phlegm (mucus)
Stop Use
openFDA Drug LabelingStop use and ask a doctor if • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.
Active Ingredient
openFDA Drug LabelingActive ingredients (in each extended-release tablet) Guaifenesin USP, 600 mg Dextromethorphan Hydrobromide USP, 30 mg Guaifenesin USP, 1200 mg Dextromethorphan Hydrobromide USP, 60 mg
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: GUAIFENESIN. 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 |
|---|---|---|---|---|
| 52493-038-89 | 52493-038 | Amneal Pharmaceuticals Co. (I) Pvt. Ltd. | 12 kg in 1 DRUM (52493-038-89) | July 3, 2024 |
| 52493-039-89 | 52493-039 | Amneal Pharmaceuticals Co. (I) Pvt. Ltd. | 11 kg in 1 DRUM (52493-039-89) | July 3, 2024 |
| 65162-038-03 | 65162-038 | Amneal Pharmaceuticals LLC | 1 BOTTLE in 1 CARTON (65162-038-03) / 30 TABLET, EXTENDED RELEASE in 1 BOTTLE | November 1, 2018 |
| 65162-038-06 | 65162-038 | Amneal Pharmaceuticals LLC | 1 BOTTLE in 1 CARTON (65162-038-06) / 60 TABLET, EXTENDED RELEASE in 1 BOTTLE | November 1, 2018 |
| 65162-038-17 | 65162-038 | Amneal Pharmaceuticals LLC | 2 BLISTER PACK in 1 CARTON (65162-038-17) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | November 1, 2018 |
| 65162-039-03 | 65162-039 | Amneal Pharmaceuticals LLC | 1 BOTTLE in 1 CARTON (65162-039-03) / 30 TABLET, EXTENDED RELEASE in 1 BOTTLE | November 1, 2018 |
| 65162-039-06 | 65162-039 | Amneal Pharmaceuticals LLC | 1 BOTTLE in 1 CARTON (65162-039-06) / 60 TABLET, EXTENDED RELEASE in 1 BOTTLE | November 1, 2018 |
| 65162-039-17 | 65162-039 | Amneal Pharmaceuticals LLC | 2 BLISTER PACK in 1 CARTON (65162-039-17) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | November 1, 2018 |
| 59651-068-15 | 59651-068 | Aurobindo Pharma Limited | 1500 TABLET, EXTENDED RELEASE in 1 BAG (59651-068-15) | March 17, 2017 |
| 59651-069-82 | 59651-069 | Aurobindo Pharma Limited | 800 TABLET, EXTENDED RELEASE in 1 BAG (59651-069-82) | March 17, 2017 |
| 58602-714-05 | 58602-714 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-714-05) / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE | March 17, 2017 |
| 58602-714-07 | 58602-714 | Aurohealth LLC | 6 BLISTER PACK in 1 CARTON (58602-714-07) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (58602-714-03) | March 17, 2017 |
| 58602-714-08 | 58602-714 | Aurohealth LLC | 4 BLISTER PACK in 1 CARTON (58602-714-08) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (58602-714-03) | March 17, 2017 |
| 58602-714-09 | 58602-714 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-714-09) / 30 TABLET, EXTENDED RELEASE in 1 BOTTLE | March 17, 2017 |
| 58602-714-12 | 58602-714 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-714-12) / 40 TABLET, EXTENDED RELEASE in 1 BOTTLE | March 17, 2017 |
| 58602-714-15 | 58602-714 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-714-15) / 60 TABLET, EXTENDED RELEASE in 1 BOTTLE | March 17, 2017 |
| 58602-714-66 | 58602-714 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-714-66) / 58 TABLET, EXTENDED RELEASE in 1 BOTTLE | March 17, 2017 |
| 58602-714-67 | 58602-714 | Aurohealth LLC | 2 BLISTER PACK in 1 CARTON (58602-714-67) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (58602-714-03) | March 17, 2017 |
| 58602-714-73 | 58602-714 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-714-73) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE | March 17, 2017 |
| 58602-715-05 | 58602-715 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-715-05) / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE | March 17, 2017 |
| 58602-715-06 | 58602-715 | Aurohealth LLC | 6 BLISTER PACK in 1 CARTON (58602-715-06) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | March 17, 2017 |
| 58602-715-09 | 58602-715 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-715-09) / 30 TABLET, EXTENDED RELEASE in 1 BOTTLE | March 17, 2017 |
| 58602-715-10 | 58602-715 | Aurohealth LLC | 6 BLISTER PACK in 1 CARTON (58602-715-10) / 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | March 17, 2017 |
| 58602-715-15 | 58602-715 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-715-15) / 60 TABLET, EXTENDED RELEASE in 1 BOTTLE | March 17, 2017 |
| 58602-715-57 | 58602-715 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-715-57) / 28 TABLET, EXTENDED RELEASE in 1 BOTTLE | March 17, 2017 |
| 58602-715-60 | 58602-715 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-715-60) / 42 TABLET, EXTENDED RELEASE in 1 BOTTLE | March 17, 2017 |
| 58602-715-64 | 58602-715 | Aurohealth LLC | 1 BLISTER PACK in 1 CARTON (58602-715-64) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | March 17, 2017 |
| 58602-715-65 | 58602-715 | Aurohealth LLC | 2 BLISTER PACK in 1 CARTON (58602-715-65) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | March 17, 2017 |
| 58602-715-68 | 58602-715 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-715-68) / 38 TABLET, EXTENDED RELEASE in 1 BOTTLE | March 17, 2017 |
| 58602-715-69 | 58602-715 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-715-69) / 44 TABLET, EXTENDED RELEASE in 1 BOTTLE | March 17, 2017 |
| 58602-715-70 | 58602-715 | Aurohealth LLC | 4 BLISTER PACK in 1 CARTON (58602-715-70) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | March 17, 2017 |
| 58602-824-08 | 58602-824 | Aurohealth LLC | 4 BLISTER PACK in 1 CARTON (58602-824-08) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | March 17, 2017 |
| 58602-824-67 | 58602-824 | Aurohealth LLC | 2 BLISTER PACK in 1 CARTON (58602-824-67) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | March 17, 2017 |
| 58602-825-06 | 58602-825 | Aurohealth LLC | 6 BLISTER PACK in 1 CARTON (58602-825-06) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | March 17, 2017 |
| 58602-825-65 | 58602-825 | Aurohealth LLC | 2 BLISTER PACK in 1 CARTON (58602-825-65) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | March 17, 2017 |
| 58602-849-11 | 58602-849 | Aurohealth LLC | 8 BLISTER PACK in 1 CARTON (58602-849-11) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | August 13, 2020 |
| 58602-849-15 | 58602-849 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-849-15) / 60 TABLET, EXTENDED RELEASE in 1 BOTTLE | August 13, 2020 |
| 58602-849-57 | 58602-849 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-849-57) / 28 TABLET, EXTENDED RELEASE in 1 BOTTLE | September 8, 2020 |
| 58602-849-64 | 58602-849 | Aurohealth LLC | 1 BLISTER PACK in 1 CARTON (58602-849-64) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | February 24, 2021 |
| 58602-849-65 | 58602-849 | Aurohealth LLC | 2 BLISTER PACK in 1 CARTON (58602-849-65) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | May 16, 2020 |
| 58602-871-83 | 58602-871 | Aurohealth LLC | 1 BLISTER PACK in 1 CARTON (58602-871-83) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | February 24, 2021 |
| 51316-009-01 | 51316-009 | CVS Pharmacy | 5 BLISTER PACK in 1 CARTON (51316-009-01) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | August 15, 2023 |
| 43598-114-01 | 43598-114 | Dr. Reddy's Laboratories Inc. | 5 BLISTER PACK in 1 CARTON (43598-114-01) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | August 15, 2023 |
| 43598-114-10 | 43598-114 | Dr. Reddy's Laboratories Inc. | 1000 TABLET, EXTENDED RELEASE in 1 POUCH (43598-114-10) | September 13, 2023 |
| 43598-114-20 | 43598-114 | Dr. Reddy's Laboratories Inc. | 1 BLISTER PACK in 1 CARTON (43598-114-20) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | August 15, 2023 |
| 43598-114-40 | 43598-114 | Dr. Reddy's Laboratories Inc. | 2 BLISTER PACK in 1 CARTON (43598-114-40) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | August 15, 2023 |
| 43598-115-10 | 43598-115 | Dr. Reddy's Laboratories Inc. | 1000 TABLET, EXTENDED RELEASE in 1 POUCH (43598-115-10) | September 13, 2023 |
| 43598-115-28 | 43598-115 | Dr. Reddy's Laboratories Inc. | 4 BLISTER PACK in 1 CARTON (43598-115-28) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | August 15, 2023 |
| 43598-115-32 | 43598-115 | Dr. Reddy's Laboratories Inc. | 2 BLISTER PACK in 1 CARTON (43598-115-32) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | August 15, 2023 |
| 43598-115-37 | 43598-115 | Dr. Reddy's Laboratories Inc. | 3 BLISTER PACK in 1 CARTON (43598-115-37) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (43598-115-74) | August 15, 2023 |
| 43598-115-42 | 43598-115 | Dr. Reddy's Laboratories Inc. | 6 BLISTER PACK in 1 CARTON (43598-115-42) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | August 15, 2023 |
| 43598-115-56 | 43598-115 | Dr. Reddy's Laboratories Inc. | 4 BLISTER PACK in 1 CARTON (43598-115-56) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (43598-115-74) | May 30, 2024 |
| 43598-115-70 | 43598-115 | Dr. Reddy's Laboratories Inc. | 1 BLISTER PACK in 1 CARTON (43598-115-70) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | August 15, 2023 |
| 43598-231-01 | 43598-231 | Dr. Reddy's Laboratories Inc. | 5 BLISTER PACK in 1 CARTON (43598-231-01) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | November 23, 2023 |
| 43598-232-37 | 43598-232 | Dr. Reddy's Laboratories Inc. | 3 BLISTER PACK in 1 CARTON (43598-232-37) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | December 1, 2023 |
| 30142-275-05 | 30142-275 | KROGER COMPANY | 4 BLISTER PACK in 1 CARTON (30142-275-05) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | May 21, 2024 |
| 30142-275-14 | 30142-275 | KROGER COMPANY | 2 BLISTER PACK in 1 CARTON (30142-275-14) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | May 21, 2024 |
| 30142-276-20 | 30142-276 | KROGER COMPANY | 2 BLISTER PACK in 1 CARTON (30142-276-20) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | May 27, 2024 |
| 30142-276-40 | 30142-276 | KROGER COMPANY | 4 BLISTER PACK in 1 CARTON (30142-276-40) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | May 27, 2024 |
| 30142-948-20 | 30142-948 | Kroger Company | 1 BLISTER PACK in 1 CARTON (30142-948-20) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | May 23, 2022 |
| 30142-948-40 | 30142-948 | Kroger Company | 2 BLISTER PACK in 1 CARTON (30142-948-40) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | May 23, 2022 |
| 30142-963-14 | 30142-963 | Kroger Company | 1 BLISTER PACK in 1 CARTON (30142-963-14) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | May 23, 2022 |
| 30142-963-28 | 30142-963 | Kroger Company | 2 BLISTER PACK in 1 CARTON (30142-963-28) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | May 23, 2022 |
| 51660-110-54 | 51660-110 | OHM LABORATORIES INC | 1 BLISTER PACK in 1 CARTON (51660-110-54) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | July 1, 2021 |
| 51660-110-58 | 51660-110 | OHM LABORATORIES INC | 3 BLISTER PACK in 1 CARTON (51660-110-58) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | June 5, 2026 |
| 51660-110-86 | 51660-110 | OHM LABORATORIES INC | 2 BLISTER PACK in 1 CARTON (51660-110-86) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | July 1, 2021 |
| 51660-301-21 | 51660-301 | OHM LABORATORIES INC | 1 BLISTER PACK in 1 CARTON (51660-301-21) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | July 1, 2021 |
| 51660-301-41 | 51660-301 | OHM LABORATORIES INC | 2 BLISTER PACK in 1 CARTON (51660-301-41) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | July 1, 2021 |
| 51660-301-61 | 51660-301 | OHM LABORATORIES INC | 3 BLISTER PACK in 1 CARTON (51660-301-61) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | June 5, 2026 |
| 41415-998-20 | 41415-998 | PUBLIX SUPER MARKETS, INC | 1 BLISTER PACK in 1 CARTON (41415-998-20) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | July 1, 2021 |
| 41415-999-14 | 41415-999 | PUBLIX SUPER MARKETS, INC | 1 BLISTER PACK in 1 CARTON (41415-999-14) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | July 1, 2021 |
| 63304-106-21 | 63304-106 | SUN PHARMACEUTICAL INDUSTRIES, INC. | 1 BLISTER PACK in 1 CARTON (63304-106-21) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | July 1, 2021 |
| 63304-110-54 | 63304-110 | SUN PHARMACEUTICAL INDUSTRIES, INC. | 1 BLISTER PACK in 1 CARTON (63304-110-54) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | July 1, 2021 |
| 85766-046-28 | 85766-046 | Sportpharm LLC | 4 BLISTER PACK in 1 CARTON (85766-046-28) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | August 2, 2025 |
| 85766-150-14 | 85766-150 | Sportpharm LLC | 1 BOTTLE in 1 CARTON (85766-150-14) / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE | February 19, 2026 |
| 76162-032-56 | 76162-032 | TOPCO ASSOCIATES LLC | 8 BLISTER PACK in 1 CARTON (76162-032-56) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | April 23, 2026 |
| 11673-267-05 | 11673-267 | Target Corporation | 1 BOTTLE in 1 CARTON (11673-267-05) / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE | July 4, 2024 |
| 11673-267-57 | 11673-267 | Target Corporation | 1 BOTTLE in 1 CARTON (11673-267-57) / 28 TABLET, EXTENDED RELEASE in 1 BOTTLE | July 4, 2024 |
| 11673-267-60 | 11673-267 | Target Corporation | 1 BOTTLE in 1 CARTON (11673-267-60) / 42 TABLET, EXTENDED RELEASE in 1 BOTTLE | July 4, 2024 |
| 71179-011-21 | 71179-011 | VESPYR BRANDS LLC | 3 BLISTER PACK in 1 CARTON (71179-011-21) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | July 14, 2022 |
| 52493-038 | 52493-038 | Amneal Pharmaceuticals Co. (I) Pvt. Ltd. | — | July 3, 2024 |
| 52493-039 | 52493-039 | Amneal Pharmaceuticals Co. (I) Pvt. Ltd. | — | July 3, 2024 |
| 65162-038 | 65162-038 | Amneal Pharmaceuticals LLC | — | November 1, 2018 |
| 65162-039 | 65162-039 | Amneal Pharmaceuticals LLC | — | November 1, 2018 |
| 59651-068 | 59651-068 | Aurobindo Pharma Limited | — | March 17, 2017 |
| 59651-069 | 59651-069 | Aurobindo Pharma Limited | — | March 17, 2017 |
| 58602-714 | 58602-714 | Aurohealth LLC | — | March 17, 2017 |
| 58602-715 | 58602-715 | Aurohealth LLC | — | March 17, 2017 |
| 58602-824 | 58602-824 | Aurohealth LLC | — | March 17, 2017 |
| 58602-825 | 58602-825 | Aurohealth LLC | — | March 17, 2017 |
| 58602-849 | 58602-849 | Aurohealth LLC | — | May 16, 2020 |
| 58602-871 | 58602-871 | Aurohealth LLC | — | February 24, 2021 |
| 51316-009 | 51316-009 | CVS Pharmacy | — | August 15, 2023 |
| 43598-114 | 43598-114 | Dr. Reddy's Laboratories Inc. | — | August 15, 2023 |
| 43598-115 | 43598-115 | Dr. Reddy's Laboratories Inc. | — | August 15, 2023 |
| 43598-231 | 43598-231 | Dr. Reddy's Laboratories Inc. | — | August 15, 2023 |
| 43598-232 | 43598-232 | Dr. Reddy's Laboratories Inc. | — | August 15, 2023 |
| 30142-275 | 30142-275 | KROGER COMPANY | — | May 21, 2024 |
| 30142-276 | 30142-276 | KROGER COMPANY | — | May 27, 2024 |
| 30142-948 | 30142-948 | Kroger Company | — | May 23, 2022 |
| 30142-963 | 30142-963 | Kroger Company | — | May 23, 2022 |
| 51660-110 | 51660-110 | OHM LABORATORIES INC | — | July 1, 2021 |
| 51660-301 | 51660-301 | OHM LABORATORIES INC | — | July 1, 2021 |
| 41415-998 | 41415-998 | PUBLIX SUPER MARKETS, INC | — | July 1, 2021 |
| 41415-999 | 41415-999 | PUBLIX SUPER MARKETS, INC | — | July 1, 2021 |
| 63304-106 | 63304-106 | SUN PHARMACEUTICAL INDUSTRIES, INC. | — | July 1, 2021 |
| 63304-110 | 63304-110 | SUN PHARMACEUTICAL INDUSTRIES, INC. | — | July 1, 2021 |
| 85766-046 | 85766-046 | Sportpharm LLC | — | March 17, 2017 |
| 85766-150 | 85766-150 | Sportpharm LLC | — | March 17, 2017 |
| 76162-032 | 76162-032 | TOPCO ASSOCIATES LLC | — | April 23, 2026 |
| 11673-267 | 11673-267 | Target Corporation | — | July 4, 2024 |
| 71179-011 | 71179-011 | VESPYR BRANDS LLC | — | July 14, 2022 |
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 · 10 sections on this page.