IBUPROFEN

Product NDC: 0363-1610
Requested package NDC: 0363-1610-44
11-digit product format: 003631610
Labeler code: 0363
Product ID: 0363-1610_13af6333-7380-e54c-e063-6294a90aaa35
Type: HUMAN OTC DRUG
Nonproprietary name: IBUPROFEN
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: WALGREENS
Application: ANDA079205
Marketing category: ANDA
Marketing start: 2016-01-27
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
A079205-001	IBUPROFEN	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL			2009-06-26

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	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`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
310964	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
3ce5b71b-f841-444f-bf66-023e4bd9aa16	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
0363-1610-23	2020-05-08	610T Walgreen 0363-1610 Ibuprofen Capsules 200 mg
0363-1610-31	2020-05-08	610T Walgreen 0363-1610 Ibuprofen Capsules 200 mg
0363-1610-44	2020-05-08	610T Walgreen 0363-1610 Ibuprofen Capsules 200 mg
0363-1610-66	2020-05-08	610T Walgreen 0363-1610 Ibuprofen Capsules 200 mg
0363-1610-80	2020-05-08	610T Walgreen 0363-1610 Ibuprofen Capsules 200 mg
0363-1610-23	2020-01-31	610T Walgreen 0363-1610 Ibuprofen Capsules 200 mg
0363-1610-31	2020-01-31	610T Walgreen 0363-1610 Ibuprofen Capsules 200 mg
0363-1610-44	2020-01-31	610T Walgreen 0363-1610 Ibuprofen Capsules 200 mg
0363-1610-66	2020-01-31	610T Walgreen 0363-1610 Ibuprofen Capsules 200 mg
0363-1610-80	2020-01-31	610T Walgreen 0363-1610 Ibuprofen Capsules 200 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0363-1610-23	IBUPROFEN	20 in 1 BOTTLE, PLASTIC	CAPSULE, LIQUID FILLED	20	4
0363-1610-31	IBUPROFEN	300 in 1 BOTTLE, PLASTIC	CAPSULE, LIQUID FILLED	300	4
0363-1610-44	IBUPROFEN	40 in 1 BOTTLE, PLASTIC	CAPSULE, LIQUID FILLED	40	4
0363-1610-66	IBUPROFEN	160 in 1 BOTTLE, PLASTIC	CAPSULE, LIQUID FILLED	160	4
0363-1610-80	IBUPROFEN	80 in 1 BOTTLE, PLASTIC	CAPSULE, LIQUID FILLED	80	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0363-1610-23	EA - Each	0363-1610	6953475b-6bd7-4e19-ad2d-9616384a76c3	1	2022-06-06
0363-1610-31	EA - Each	0363-1610	b549774f-eefa-4ed9-aae9-f14b4a4ab65b	1	2022-06-06
0363-1610-44	EA - Each	0363-1610	fc8af483-493f-47a3-907b-5ded6e8e49ba	1	2022-06-06
0363-1610-66	EA - Each	0363-1610	23edadc2-b052-4ca9-b7e8-eda506df5e81	1	2022-06-06
0363-1610-80	EA - Each	0363-1610	72fec919-d9ee-4711-b317-eff8707bc90c	1	2022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0363-1610	IBUPROFEN CAPSULE, LIQUID FILLED [WALGREENS]	4	Current NDC, Legacy NDC, 5 package rows	20240316_3ce5b71b-f841-444f-bf66-023e4bd9aa16.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 2 · 25 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	Harris Teeter	87ffbf01-54de-45a8-b2a3-367d21927882	2026-07-29	Warnings	Exact identifier application applno (ANDA): 079205 application number: ANDA079205
Ibuprofen Minis	IBUPROFEN	Grocery Outlet, Inc.	44665e3d-37a7-a1a7-e063-6294a90ab376	2026-03-04	Warnings	Exact identifier application applno (ANDA): 079205 application number: ANDA079205
Ibuprofen	IBUPROFEN	WALGREENS	40a1e525-fb1e-08f4-e063-6294a90adfa7	2026-01-14	Warnings	Exact identifier application applno (ANDA): 079205 application number: ANDA079205
IBUPROFEN	IBUPROFEN	TIME CAP LABORATORIES, INC	e0a8315a-80a5-4be3-aad1-3d01f00df494	2025-12-29	Warnings	Exact identifier application applno (ANDA): 079205 application number: ANDA079205
Ibuprofen	IBUPROFEN	AMERIFOODS TRADING COMPANY	3802ebc9-83ca-602a-e063-6294a90a11c8	2025-11-20	Warnings	Exact identifier application applno (ANDA): 079205 application number: ANDA079205
Ibuprofen	IBUPROFEN	BJWC (Berkley & Jensen / BJ's)	2f322afb-bfc8-9dab-e063-6394a90a08b5	2025-08-19	Warnings	Exact identifier application applno (ANDA): 079205 application number: ANDA079205
Ibuprofen	IBUPROFEN	FSA STORE INC.	ec6b1b86-46fc-7e82-e053-2a95a90ac147	2025-08-12	Warnings	Exact identifier application applno (ANDA): 079205 application number: ANDA079205
Ibuprofen	IBUPROFEN	MARC GLASSMAN, INC.	7f366669-9d31-46c7-932d-02fa64b11f30	2025-07-15	Warnings	Exact identifier application applno (ANDA): 079205 application number: ANDA079205
Ibuprofen	IBUPROFEN	United Natural Foods, Inc. dba UNFI	37eaa3b1-98e9-4fcf-ae74-153bfc35551f	2025-07-01	Warnings	Exact identifier application applno (ANDA): 079205 application number: ANDA079205
IBUPROFEN	IBUPROFEN	SPIRIT PHARMACEUTICALS,LLC	2810122e-3c89-49a2-8dac-db3714cb7b45	2024-12-30	Warnings	Exact identifier application applno (ANDA): 079205 application number: ANDA079205
Ibuprofen	IBUPROFEN	Winco Foods, LLC	61cd9140-eded-4bcf-894b-a163fa5f3e10	2024-12-06	Warnings	Exact identifier application applno (ANDA): 079205 application number: ANDA079205
PROPRINAL	IBUPROFEN CAPSULES 200 MG	HART Health	ec27b625-a3fa-4c5f-8134-c9373c09b3e3	2024-12-04	Warnings	Exact identifier application applno (ANDA): 079205 application number: ANDA079205
Ibuprofen	IBUPROFEN	BETTER LIVING BRANDS, LLC	eb619068-be71-7569-e053-2a95a90a4a6e	2024-10-26	Warnings	Exact identifier application applno (ANDA): 079205 application number: ANDA079205
IBUPROFEN	IBUPROFEN	Kroger Company	bc178013-ab2e-04f5-e053-2995a90a1ed4	2024-04-13	Warnings	Exact identifier application applno (ANDA): 079205 application number: ANDA079205
Ibuprofen	IBUPROFEN	KROGER COMPANY	0fbe42d0-b5f0-0780-e063-6394a90a4ecb	2024-04-13	Warnings	Exact identifier application applno (ANDA): 079205 application number: ANDA079205
IBUPROFEN	IBUPROFEN	WALGREENS	3ce5b71b-f841-444f-bf66-023e4bd9aa16	2024-03-15	Warnings	Exact identifier application applno (ANDA): 079205 application number: ANDA079205 ndc (package): 0363-1610-44 ndc (product): 0363-1610 ndc11 (package): 00363161044
PROPRINAL	IBUPROFEN CAPSULES 200 MG	A-S Medication Solutions	4723dd14-5d20-4a9a-b127-4237d5db5956	2024-01-29	Warnings	Exact identifier application applno (ANDA): 079205 application number: ANDA079205
IBUPROFEN	IBUPROFEN	TARGET CORPORATION	8e8646fe-fd62-1662-e053-2a95a90a3008	2024-01-03	Warnings	Exact identifier application applno (ANDA): 079205 application number: ANDA079205
Ibuprofen Mini	IBUPROFEN MINI 200 MG	TARGET CORPORATION	c80426d9-e121-c24d-e053-2a95a90acf2f	2024-01-03	Warnings	Exact identifier application applno (ANDA): 079205 application number: ANDA079205
Ibuprofen	IBUPROFEN	TIME CAP LABORATORIES, INC.	059cb22f-f6db-5d03-e063-6294a90a9ec1	2023-10-27	Warnings	Exact identifier application applno (ANDA): 079205 application number: ANDA079205

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
310964	ibuprofen 200 MG Oral Capsule	PSN	3ce5b71b-f841-444f-bf66-023e4bd9aa16	4
310964	ibuprofen 200 MG Oral Capsule	SCD	3ce5b71b-f841-444f-bf66-023e4bd9aa16	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0363-1610-44	00363161044	40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0363-1610-44)	2016-01-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
610T Walgreen 0363-1610 Ibuprofen Capsules 200 mg	WALGREENS \| TIME CAP LABORATORIES, INC \| MARKSANS PHARMA LIMITED	2024-03-15	HUMAN OTC DRUG LABEL	4