ibuprofen

Product NDC: 72789-191
Requested package NDC: 72789-191-21
11-digit product format: 727890191
Labeler code: 72789
Product ID: 72789-191_460208a0-114d-960f-e063-6294a90a0981
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA072096
Marketing category: ANDA
Marketing start: 2018-09-20
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: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
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…`
2022-10-28 04:53 UTC	2022-10	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: ibuprofen
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
IBUPROFEN	200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
WK2XYI10QM	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310965	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
96bff700-bca3-4b94-b8a2-379102721db8	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1e73f975-1ce7-705e-2bcf-788b1b5e24ba	Product name	5	20251124
16cde546-8deb-4df2-a072-dab5566ede95	Product name	1	20231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015	Product name	4	20230808
874f4e63-49d2-5150-5d77-052172814ebd	Product name	6	20230105
557673c2-8256-b351-e863-4ec71a5a64b0	Product name	2	20160714
dbc9a339-6215-4e94-9546-57a3b34902ce	Product name	1	20160517
61c18d4e-b552-5478-8fc0-df38b93e3100	Product name	1	20140508
7b2938c9-7eb7-e312-ae90-f54f4240361e	Product name	1	20140508
997601aa-bb5f-6971-6b90-a21132c12c7b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
72789-191-20	ibuprofen	20 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	20	10
72789-191-21	ibuprofen	21 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	21	10
72789-191-30	ibuprofen	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72789-191-20	EA - Each	72789-191	df63a82b-99da-41c5-a844-17e8b04b6449	1	2023-06-06
72789-191-21	EA - Each	72789-191	f0e544a4-b9bd-4c58-a5f8-a8f89671dc81	1	2026-01-08
72789-191-30	EA - Each	72789-191	45bc31cb-5fe1-4fd4-abe4-0764c547aad9	1	2022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72789-191	IBUPROFEN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	9	Current NDC, Legacy NDC, 3 package rows	20250503_96bff700-bca3-4b94-b8a2-379102721db8.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 1 of 4 · 65 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
IBUPROFEN	IBUPROFEN	Amazon.com Services LLC	b5a47efe-222f-4cbd-b649-caafd16a0829	2026-07-29	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
ibuprofen	IBUPROFEN	HyVee Inc	e7175dc9-db39-4452-a419-85af179de422	2026-07-16	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
good sense ibuprofen	IBUPROFEN	Bryant Ranch Prepack	d6460cc3-c207-44e0-bf78-ad6fef055ed5	2026-07-09	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
ibuprofen	IBUPROFEN	Unit Dose Solutions, Inc.	551535ce-eab0-bb13-e063-6294a90a2070	2026-06-25	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
Berkley and Jensen Ibuprofen	IBUPROFEN	BJWC	cda57e42-6106-46ee-82d1-479a692ee5bb	2026-05-21	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
good neighbor pharmacy ibuprofen	IBUPROFEN	Amerisource Bergen	085dcc1a-e4b0-4d08-9476-72275382d1a1	2026-05-15	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
good sense ibuprofen	IBUPROFEN	Preferred Pharmaceuticals Inc.	f1a03b1f-2d87-43cc-b256-bd296ccd09f2	2026-05-13	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
ibuprofen	IBUPROFEN	Kroger Company	6307485a-8be6-40ee-899b-00eb3ee8ce61	2026-05-01	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
CounterAct IB	IBUPROFEN	Melaleuca, Inc	7fafc13e-3fee-ace3-e053-2a91aa0ac2ea	2026-03-17	Boxed warning, Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
Leader Ibuprofen	IBUPROFEN	Cardinal Health 110, LLC. dba Leader	d673266c-3d2b-479f-9b53-cdd1b8651393	2026-02-25	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
ibuprofen	IBUPROFEN	HyVee Inc	4c24c884-55f7-40b4-8d6f-db6144d5ebcb	2026-02-05	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
ibuprofen	IBUPROFEN	HyVee Inc	5233c409-3743-4312-9f75-14ded6755b5c	2026-02-02	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
equate ibuprofen	IBUPROFEN	Wal-Mart Stores Inc	b29034a6-657b-426f-a41a-5e64c4bc759d	2026-01-20	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
ibuprofen	IBUPROFEN	CVS Pharmacy	ace493e6-91bc-41aa-8e5c-5bc14981de91	2026-01-06	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
ibuprofen	IBUPROFEN	Northwind Health Company, LLC	da6c2802-5d15-dbcb-e053-2a95a90a2561	2026-01-01	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
ibuprofen	IBUPROFEN	NuCare Pharmaceuticals, Inc.	463ea713-6b27-b00b-e063-6394a90a8646	2025-12-18	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
ibuprofen	IBUPROFEN	PD-Rx Pharmaceuticals, Inc.	96bff700-bca3-4b94-b8a2-379102721db8	2025-12-15	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096 ndc (package): 72789-191-21 ndc (product): 72789-191 ndc11 (package): 72789019121
good sense ibuprofen	IBUPROFEN	Preferred Pharmaceuticals Inc.	c447fc6b-e9ef-447a-9609-5f893e18dfa7	2025-11-17	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
GOODNOW PAIN RELIEF	IBUPROFEN	Gobrands, Inc	0759085d-6ac3-446b-ac2c-8dc30e32e1d1	2025-11-08	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
Ibuprofen	IBUPROFEN	Rite Aid Corporation	1dba3cb7-2e3d-4378-93cf-92db8f24f41f	2025-10-09	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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310965	ibuprofen 200 MG Oral Tablet	PSN	96bff700-bca3-4b94-b8a2-379102721db8	10
310965	ibuprofen 200 MG Oral Tablet	SCD	96bff700-bca3-4b94-b8a2-379102721db8	10
310965	ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral Tablet	SY	96bff700-bca3-4b94-b8a2-379102721db8	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
72789-191-21	72789019121	21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-191-21)	2025-12-15	No	No	Current