Ibuprofen

Product NDC: 21130-992
Requested package NDC: 21130-992-05
11-digit product format: 211300992
Labeler code: 21130
Product ID: 21130-992_01efeeef-bb93-3c38-e063-6294a90a86bb
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen Tablets USP, 200mg
Dosage form: TABLET
Route: ORAL
Labeler: BETTER LIVING BRANDS, LLC
Application: ANDA091237
Marketing category: ANDA
Marketing start: 2023-08-08
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 1.

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
A091237-001	IBUPROFEN	IBUPROFEN	200MG	TABLET / ORAL			2011-02-08

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`cb3db0bc1861…`

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
eb60a1e5-fb6e-360f-e053-2a95a90ade04	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
21130-992-01	Ibuprofen	100 in 1 BOTTLE	TABLET	100	2
21130-992-01	Ibuprofen	1 in 1 CARTON	TABLET	1	2
21130-992-05	Ibuprofen	50 in 1 BOTTLE	TABLET	50	2
21130-992-05	Ibuprofen	1 in 1 CARTON	TABLET	1	2
21130-992-53	Ibuprofen	500 in 1 BOTTLE	TABLET	500	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21130-992	IBUPROFEN (IBUPROFEN TABLETS USP, 200MG) TABLET [BETTER LIVING BRANDS, LLC]	2	Current NDC, 5 package rows	20230811_eb60a1e5-fb6e-360f-e053-2a95a90ade04.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 1 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	CVS Pharmacy. Inc.	d4336a7c-fb9f-1fbe-e053-2995a90af365	2025-09-13	Warnings	Exact identifier application applno (ANDA): 091237 application number: ANDA091237
Ibuprofen	IBUPROFEN	CVS Pharmacy.Inc.	cd0c3404-9e9d-bfad-e053-2995a90a8719	2025-09-13	Warnings	Exact identifier application applno (ANDA): 091237 application number: ANDA091237
IBUPROFEN	IBUPROFEN	TIME CAP LABORATORIES,INC	82aad715-f652-471b-840c-5151c66e5ade	2024-08-28	Warnings	Exact identifier application applno (ANDA): 091237 application number: ANDA091237
Ibuprofen	IBUPROFEN TABLETS USP, 200MG	KROGER COMPANY	0fbe42d0-b5f2-0780-e063-6394a90a4ecb	2024-04-13	Warnings	Exact identifier application applno (ANDA): 091237 application number: ANDA091237
IBUPROFEN	IBUPROFEN	WALGREENS	76f4cc25-a77e-6245-e053-2a91aa0af7ae	2024-03-18	Warnings	Exact identifier application applno (ANDA): 091237 application number: ANDA091237
IBUPROFEN	IBUPROFEN	WALGREENS	76f15be2-4682-5015-e053-2991aa0af0d2	2024-03-15	Warnings	Exact identifier application applno (ANDA): 091237 application number: ANDA091237
IBUPROFEN	IBUPROFEN	TARGET CORPORATION	8e872c8d-28e2-cd49-e053-2995a90a469f	2024-01-03	Warnings	Exact identifier application applno (ANDA): 091237 application number: ANDA091237
Ibuprofen	IBUPROFEN TABLETS USP, 200MG	BETTER LIVING BRANDS, LLC	eb60a1e5-fb6e-360f-e053-2a95a90ade04	2023-08-03	Warnings	Exact identifier application applno (ANDA): 091237 application number: ANDA091237 ndc (package): 21130-992-05 ndc (product): 21130-992 ndc11 (package): 21130099205
Ibuprofen	IBUPROFEN	CARDINAL HEALTH	dfbbde4f-633d-6d57-e053-2a95a90ad82f	2022-05-24	Warnings	Exact identifier application applno (ANDA): 091237 application number: ANDA091237
IBUPROFEN	IBUPROFEN	RITE AID	a7abf95e-d444-42da-e053-2995a90a88d3	2022-01-03	Warnings	Exact identifier application applno (ANDA): 091237 application number: ANDA091237
IBUPROFEN	IBUPROFEN	RITE AID	a7ac8b55-2758-400e-e053-2995a90a0eed	2022-01-03	Warnings	Exact identifier application applno (ANDA): 091237 application number: ANDA091237
Ibuprofen	IBUPROFEN	MARKSANS PHARMA LIMITED	859d7190-586f-4766-a7e7-9e800a72d58b	2021-12-21	Warnings	Exact identifier application applno (ANDA): 091237 application number: ANDA091237

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	eb60a1e5-fb6e-360f-e053-2a95a90ade04	2
310965	ibuprofen 200 MG Oral Tablet	SCD	eb60a1e5-fb6e-360f-e053-2a95a90ade04	2
310965	ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral Tablet	SY	eb60a1e5-fb6e-360f-e053-2a95a90ade04	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
21130-992-05	21130099205	1 BOTTLE in 1 CARTON (21130-992-05) / 50 TABLET in 1 BOTTLE	1 bottle	2023-08-08	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
612R_21130-992_Albertsons_Ibuprofen Tablets USP, 200mg	BETTER LIVING BRANDS, LLC \| TIME CAP LABORATORIES, INC \| MARKSANS PHARMA LIMITED	2023-08-03	HUMAN OTC DRUG LABEL	2