ibuprofen

Product NDC: 68788-7983
11-digit product format: 687887983
Labeler code: 68788
Product ID: 68788-7983_a0381639-4e81-4db7-a0b6-5b7223387b04
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA072096
Marketing category: ANDA
Marketing start: 2021-08-05
Marketing end: 0000-00-00
Substance: IBUPROFEN
Active strength: 200 mg/1
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68788-7983		D	Discontinued by firm	2026-10-15
excluded package	package	68788-7983	68788-7983-1	D	Discontinued by firm	2026-10-15
excluded package	package	68788-7983	68788-7983-2	D	Discontinued by firm	2026-10-15
excluded package	package	68788-7983	68788-7983-3	D	Discontinued by firm	2026-10-15
excluded package	package	68788-7983	68788-7983-5	D	Discontinued by firm	2026-10-15

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A072096-001	IBUPROFEN	IBUPROFEN	200MG	TABLET / ORAL			1987-12-08

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`3a93d1ddd44b…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-7983-1	EA - Each	68788-7983	fe81be05-2349-4c1e-99c6-dfc06b374ce4	1	2024-03-12
68788-7983-2	EA - Each	68788-7983	5319b832-7383-4484-9c81-8f856bb7e711	1	2024-03-12
68788-7983-3	EA - Each	68788-7983	e3eac9d0-e3b1-4b3a-99bc-55a6bd519ce9	1	2024-03-12
68788-7983-5	EA - Each	68788-7983	bb2027b1-086a-4ab3-8daf-9e428c8f6a46	1	2024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-7983	IBUPROFEN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]	4	Legacy NDC	20240525_022a1a35-27ab-4678-85de-a03bb24b88b4.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 4 of 4 · 62 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ibuprofen	IBUPROFEN	Proficient Rx LP	798d33b0-5d7a-4445-8a51-2a3d336f744a	2022-04-01	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
basic care ibuprofen	IBUPROFEN	Amazon.com Services LLC	9bbbedb3-e0b2-4645-8105-98800096cfed	2022-03-09	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WK2XYI10QM	IBUPROFEN	15687-27-1	IBUPROFEN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-7983-1	68788798301	100 TABLET, FILM COATED in 1 BOTTLE (68788-7983-1)	2021-08-05	0000-00-00	No	No	Current
68788-7983-2	68788798302	20 TABLET, FILM COATED in 1 BOTTLE (68788-7983-2)	2021-08-05	0000-00-00	No	No	Current
68788-7983-3	68788798303	30 TABLET, FILM COATED in 1 BOTTLE (68788-7983-3)	2021-08-05	0000-00-00	No	No	Current
68788-7983-5	68788798305	50 TABLET, FILM COATED in 1 BOTTLE (68788-7983-5)	2021-08-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Major Pharmaceuticals Ibuprofen Drug Facts	Preferred Pharmaceuticals Inc.	2025-06-30	HUMAN OTC DRUG LABEL	5