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Ibuprofen

ANDA Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Ibuprofen
Generic name
Ibuprofen
Dosage form
Capsule
Route
—
Marketing category
DRUG FOR FURTHER PROCESSING · BULK API
Labeler
Patheon Softgels Inc.
Product type
Drug For Further Processing
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
20
Packages
52
Data completeness
82% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Ibuprofen 200 mg/1 310965 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Capsule
Route of administration
—
Presentations
72

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Anti-Inflammatory Agents EPC All 251 members
Cyclooxygenase Inhibitors [MoA] MoA All 251 members
Non-Steroidal [CS] CS All 251 members
Nonsteroidal Anti-inflammatory Drug [EPC] EPC All 251 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
207753
Application type
ANDA · Abbreviated New Drug Application
Approval date
June 29, 2018
Sponsor
AUROBINDO PHARMA LTD
Products on application
1
Submissions recorded
1
Products approved under application 207753.
Product Trade name Form Strength Ingredient Status TE Flags
207753-001 IBUPROFEN CAPSULE IBUPROFEN Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 207753.
Type No. Action Status Date Review
Original application 1 Approved June 29, 2018 Standard

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260605). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260605 HUMAN OTC DRUG · 20230412

Indications and Usage

openFDA Drug Labeling

Uses temporarily relieves minor aches and pains due to: headache toothache backache menstrual cramps muscular aches the common cold minor pain of arthritis temporarily reduces fever

Purpose Pain reliever/Fever reducer

Dosage and Administration

openFDA Drug Labeling

Directions do not take more than directed the smallest effective dose should be used adults and children 12 years and over: take 1 capsule every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 capsule, 2 capsules may be used do not exceed 6 capsules in 24 hours, unless directed by a doctor children under 12 years: ask a doctor

Warnings Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed. Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery.

Ask a Doctor

openFDA Drug Labeling

Ask a doctor before use if stomach bleeding warning applies to you you have problems or serious side effects from taking pain relievers or fever reducers you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke you are taking a diuretic.

Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better ■ you have symptoms of heart problems or stroke: ■ chest pain ■ trouble breathing ■ weakness in one part or side of body ■ slurred speech ■ leg swelling pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear. If pregnant or breast-feeding , ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Active Ingredient

openFDA Drug Labeling

Drug Facts Active ingredient (in each capsule) Solubilized ibuprofen equal to 200 mg ibuprofen USP (NSAID)* (present as the free acid and potassium salt) *nonsteroidal anti-inflammatory drug

Adverse event reports

Source: openFDA FAERS
283,546
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: IBUPROFEN. 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
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
59651-072-82 59651-072 Aurobindo Pharma Limited 800 CAPSULE in 1 BAG (59651-072-82) June 29, 2018
59651-627-39 59651-627 Aurobindo Pharma Limited 3000 CAPSULE in 1 BAG (59651-627-39) April 15, 2021
59651-627-82 59651-627 Aurobindo Pharma Limited 800 CAPSULE in 1 BAG (59651-627-82) April 2, 2019
58602-843-12 58602-843 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-843-12) / 40 CAPSULE in 1 BOTTLE July 15, 2020
58602-843-18 58602-843 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-843-18) / 80 CAPSULE in 1 BOTTLE July 15, 2020
58602-843-30 58602-843 Aurohealth LLC 160 CAPSULE in 1 BOTTLE (58602-843-30) July 15, 2020
58602-843-32 58602-843 Aurohealth LLC 180 CAPSULE in 1 BOTTLE (58602-843-32) July 15, 2020
58602-843-34 58602-843 Aurohealth LLC 200 CAPSULE in 1 BOTTLE, PLASTIC (58602-843-34) August 27, 2020
58602-843-38 58602-843 Aurohealth LLC 300 CAPSULE in 1 BOTTLE (58602-843-38) July 15, 2020
58602-843-70 58602-843 Aurohealth LLC 1 BOTTLE, PLASTIC in 1 CARTON (58602-843-70) / 40 CAPSULE in 1 BOTTLE, PLASTIC August 27, 2020
58602-843-72 58602-843 Aurohealth LLC 1 BOTTLE, PLASTIC in 1 CARTON (58602-843-72) / 80 CAPSULE in 1 BOTTLE, PLASTIC August 27, 2020
58602-843-73 58602-843 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-843-73) / 20 CAPSULE in 1 BOTTLE July 15, 2020
58602-843-74 58602-843 Aurohealth LLC 160 CAPSULE in 1 BOTTLE, PLASTIC (58602-843-74) August 27, 2020
58602-843-75 58602-843 Aurohealth LLC 300 CAPSULE in 1 BOTTLE, PLASTIC (58602-843-75) August 27, 2020
58602-843-79 58602-843 Aurohealth LLC 2 BOTTLE in 1 CARTON (58602-843-79) / 180 CAPSULE in 1 BOTTLE July 15, 2020
58602-843-92 58602-843 Aurohealth LLC 180 CAPSULE in 1 BOTTLE, PLASTIC (58602-843-92) August 27, 2020
58602-852-32 58602-852 Aurohealth LLC 180 CAPSULE in 1 BOTTLE (58602-852-32) July 18, 2022
58602-852-38 58602-852 Aurohealth LLC 300 CAPSULE in 1 BOTTLE (58602-852-38) July 18, 2022
58602-879-38 58602-879 Aurohealth LLC 300 CAPSULE in 1 BOTTLE (58602-879-38) September 6, 2022
58602-902-12 58602-902 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-902-12) / 40 CAPSULE in 1 BOTTLE June 29, 2018
58602-902-18 58602-902 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-902-18) / 80 CAPSULE in 1 BOTTLE June 29, 2018
58602-902-30 58602-902 Aurohealth LLC 160 CAPSULE in 1 BOTTLE (58602-902-30) June 29, 2018
58602-902-32 58602-902 Aurohealth LLC 180 CAPSULE in 1 BOTTLE, PLASTIC (58602-902-32) March 31, 2020
58602-902-34 58602-902 Aurohealth LLC 200 CAPSULE in 1 BOTTLE, PLASTIC (58602-902-34) March 31, 2020
58602-902-38 58602-902 Aurohealth LLC 300 CAPSULE in 1 BOTTLE (58602-902-38) June 29, 2018
58602-902-70 58602-902 Aurohealth LLC 1 BOTTLE, PLASTIC in 1 CARTON (58602-902-70) / 40 CAPSULE in 1 BOTTLE, PLASTIC March 31, 2020
58602-902-72 58602-902 Aurohealth LLC 1 BOTTLE, PLASTIC in 1 CARTON (58602-902-72) / 80 CAPSULE in 1 BOTTLE, PLASTIC March 31, 2020
58602-902-73 58602-902 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-902-73) / 20 CAPSULE in 1 BOTTLE June 29, 2018
58602-902-74 58602-902 Aurohealth LLC 160 CAPSULE in 1 BOTTLE, PLASTIC (58602-902-74) March 31, 2020
58602-902-75 58602-902 Aurohealth LLC 300 CAPSULE in 1 BOTTLE, PLASTIC (58602-902-75) March 31, 2020
21130-032-12 21130-032 Better Living Brands LLC 1 BOTTLE in 1 CARTON (21130-032-12) / 40 CAPSULE in 1 BOTTLE September 20, 2023
21130-032-18 21130-032 Better Living Brands LLC 1 BOTTLE in 1 CARTON (21130-032-18) / 80 CAPSULE in 1 BOTTLE September 20, 2023
21130-032-32 21130-032 Better Living Brands LLC 180 CAPSULE in 1 BOTTLE (21130-032-32) September 20, 2023
21130-032-38 21130-032 Better Living Brands LLC 300 CAPSULE in 1 BOTTLE (21130-032-38) September 20, 2023
49588-0005-1 49588-0005 CATALENT ARGENTINA S.A.I.C. 1 BAG in 1 BOX (49588-0005-1) / 15000 CAPSULE in 1 BAG June 27, 2025
11014-0429-2 11014-0429 Catalent Pharma Solutions, LLC 1 BAG in 1 CARTON (11014-0429-2) / 6000 CAPSULE in 1 BAG March 19, 2014
10888-8114-1 10888-8114 Patheon Softgels Inc. 10000 CAPSULE in 1 BOX (10888-8114-1) December 5, 2017
10888-8118-1 10888-8118 Patheon Softgels Inc. 6000 CAPSULE in 1 BOX (10888-8118-1) January 1, 2018
10888-8133-1 10888-8133 Patheon Softgels Inc. 6000 CAPSULE in 1 BOX (10888-8133-1) August 1, 2014
10888-8134-1 10888-8134 Patheon Softgels Inc. 6000 CAPSULE in 1 BOX (10888-8134-1) January 7, 2014
10888-8135-1 10888-8135 Patheon Softgels Inc. 10000 CAPSULE in 1 BOX (10888-8135-1) June 2, 2010
10888-8160-1 10888-8160 Patheon Softgels Inc. 6000 CAPSULE in 1 CASE (10888-8160-1) January 28, 2019
10888-8161-1 10888-8161 Patheon Softgels Inc. 15000 CAPSULE in 1 CASE (10888-8161-1) May 4, 2020
10888-8170-1 10888-8170 Patheon Softgels Inc. 10000 CAPSULE in 1 CASE (10888-8170-1) May 10, 2018
10888-8231-1 10888-8231 Patheon Softgels Inc. 15000 CAPSULE in 1 CASE (10888-8231-1) April 30, 2021
10888-8266-1 10888-8266 Patheon Softgels, Inc. 15000 CAPSULE in 1 BOX (10888-8266-1) May 28, 2025
11822-4258-1 11822-4258 RITE AID CORPORATION 1 BOTTLE in 1 CARTON (11822-4258-1) / 20 CAPSULE in 1 BOTTLE June 24, 2022
11822-4258-2 11822-4258 RITE AID CORPORATION 1 BOTTLE in 1 CARTON (11822-4258-2) / 40 CAPSULE in 1 BOTTLE June 24, 2022
11822-4258-3 11822-4258 RITE AID CORPORATION 1 BOTTLE in 1 CARTON (11822-4258-3) / 80 CAPSULE in 1 BOTTLE June 24, 2022
11822-4258-4 11822-4258 RITE AID CORPORATION 160 CAPSULE in 1 BOTTLE (11822-4258-4) June 24, 2022
11822-4258-5 11822-4258 RITE AID CORPORATION 300 CAPSULE in 1 BOTTLE (11822-4258-5) June 24, 2022
11822-4258-6 11822-4258 RITE AID CORPORATION 200 CAPSULE in 1 BOTTLE, PLASTIC (11822-4258-6) April 12, 2023
59651-072 59651-072 Aurobindo Pharma Limited — June 29, 2018
59651-627 59651-627 Aurobindo Pharma Limited — April 2, 2019
58602-843 58602-843 Aurohealth LLC — July 15, 2020
58602-852 58602-852 Aurohealth LLC — July 18, 2022
58602-879 58602-879 Aurohealth LLC — September 6, 2022
58602-902 58602-902 Aurohealth LLC — June 29, 2018
21130-032 21130-032 Better Living Brands LLC — September 20, 2023
49588-0005 49588-0005 CATALENT ARGENTINA S.A.I.C. — June 27, 2025
11014-0429 11014-0429 Catalent Pharma Solutions, LLC — March 19, 2014
10888-8114 10888-8114 Patheon Softgels Inc. — March 24, 2009
10888-8118 10888-8118 Patheon Softgels Inc. — March 24, 2009
10888-8133 10888-8133 Patheon Softgels Inc. — March 24, 2009
10888-8134 10888-8134 Patheon Softgels Inc. — March 24, 2009
10888-8135 10888-8135 Patheon Softgels Inc. — March 24, 2009
10888-8160 10888-8160 Patheon Softgels Inc. — January 28, 2019
10888-8161 10888-8161 Patheon Softgels Inc. — May 4, 2020
10888-8170 10888-8170 Patheon Softgels Inc. — May 10, 2018
10888-8231 10888-8231 Patheon Softgels Inc. — April 30, 2021
10888-8266 10888-8266 Patheon Softgels, Inc. — May 28, 2025
11822-4258 11822-4258 RITE AID CORPORATION — June 24, 2022

Sources for this page

Every dataset that contributed a fact to 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 · 11 sections on this page.