IBUPROFEN

Product NDC: 0363-9611
Requested package NDC: 0363-9611-01
11-digit product format: 003639611
Labeler code: 0363
Product ID: 0363-9611_13eac335-12dc-1255-e063-6394a90a1ae1
Type: HUMAN OTC DRUG
Nonproprietary name: IBUPROFEN
Dosage form: TABLET
Route: ORAL
Labeler: WALGREENS
Application: ANDA091237
Marketing category: ANDA
Marketing start: 2018-12-11
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

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0363-9611	0363-9611-01	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 14 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2020-12-18 03:04 UTC · source 2020-12-17	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`caaa826d4ba7…`
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…`

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
76f4cc25-a77e-6245-e053-2a91aa0af7ae	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
0363-9611-01	2021-06-10	Walgreens Ibuprofen Tablets USP, 200 mg (Orange Round)
0363-9611-05	2021-06-10	Walgreens Ibuprofen Tablets USP, 200 mg (Orange Round)
0363-9611-10	2021-06-10	Walgreens Ibuprofen Tablets USP, 200 mg (Orange Round)
0363-9611-31	2021-06-10	Walgreens Ibuprofen Tablets USP, 200 mg (Orange Round)
0363-9611-50	2021-06-10	Walgreens Ibuprofen Tablets USP, 200 mg (Orange Round)
0363-9611-01	2020-01-31	Walgreens Ibuprofen Tablets USP, 200 mg (Orange Round)
0363-9611-05	2020-01-31	Walgreens Ibuprofen Tablets USP, 200 mg (Orange Round)
0363-9611-10	2020-01-31	Walgreens Ibuprofen Tablets USP, 200 mg (Orange Round)
0363-9611-31	2020-01-31	Walgreens Ibuprofen Tablets USP, 200 mg (Orange Round)
0363-9611-50	2020-01-31	Walgreens Ibuprofen Tablets USP, 200 mg (Orange Round)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0363-9611-01	IBUPROFEN	100 in 1 BOTTLE, PLASTIC	TABLET	100	4
0363-9611-05	IBUPROFEN	50 in 1 BOTTLE, PLASTIC	TABLET	50	4
0363-9611-10	IBUPROFEN	1000 in 1 BOTTLE, PLASTIC	TABLET	1000	4
0363-9611-31	IBUPROFEN	300 in 1 BOTTLE, PLASTIC	TABLET	300	4
0363-9611-50	IBUPROFEN	500 in 1 BOTTLE, PLASTIC	TABLET	500	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0363-9611	IBUPROFEN TABLET [WALGREENS]	4	Current NDC, Legacy NDC, 5 package rows	20240320_76f4cc25-a77e-6245-e053-2a91aa0af7ae.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 ndc (package): 0363-9611-01 ndc (product): 0363-9611 ndc11 (package): 00363961101
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
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	76f4cc25-a77e-6245-e053-2a91aa0af7ae	4
310965	ibuprofen 200 MG Oral Tablet	SCD	76f4cc25-a77e-6245-e053-2a91aa0af7ae	4
310965	ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral Tablet	SY	76f4cc25-a77e-6245-e053-2a91aa0af7ae	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0363-9611-01	00363961101	100 TABLET in 1 BOTTLE, PLASTIC (0363-9611-01)	100 tablet	2018-12-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Walgreens Ibuprofen Tablets USP, 200 mg (Orange Round)	WALGREENS \| TIME CAP LABORATORIES, INC \| MARKSANS PHARMA LIMITED	2024-03-18	HUMAN OTC DRUG LABEL	4