Ibuprofen

Product NDC: 62207-366
Requested package NDC: 62207-366-26
11-digit product format: 622070366
Labeler code: 62207
Product ID: 62207-366_f37b04a6-8c5f-0644-e053-2995a90a40a0
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen
Dosage form: TABLET
Route: ORAL
Labeler: Granules India Limited
Application: ANDA079174
Marketing category: ANDA
Marketing start: 2011-01-01
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
unfinished package	package	62207-366	62207-366-26	UNFINISHED	Active or certified unfinished drug listing		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 · 21 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	`4184dd79f89f…`	`545327b3e20f…`
2020-06-10 20:45 UTC · source 2020-06-10	`4bd3596a7b87…`	`5c64c6f6865f…`
2019-12-08 06:16 UTC · source 2019-12-05	`263afe128892…`	`91768de4ddbe…`
2019-06-01 22:24 UTC · source 2019-05-30	`5b2001dcd8f5…`	`54b53d4dc9e4…`

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
A079174-001	IBUPROFEN	IBUPROFEN	200MG	TABLET / ORAL			2010-12-10

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	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Ibuprofen
Listing expiration: 2027-12-31

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
fd01353d-1d1d-42b5-9a03-575052189bf5	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
cb89b86a-369e-4204-8910-ae797c503af3	Product name	1	20230706
874f4e63-49d2-5150-5d77-052172814ebd	Product name	6	20230105
d4880ace-a516-8c47-8dfd-73a4ba5887d7	Product name	2	20180830
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
557673c2-8256-b351-e863-4ec71a5a64b0	Product name	2	20160714
dbc9a339-6215-4e94-9546-57a3b34902ce	Product name	1	20160517
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
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
62207-366-41	Ibuprofen	24 in 1 BOTTLE	TABLET	24	18
62207-366-42	Ibuprofen	50 in 1 BOTTLE	TABLET	50	18
62207-366-43	Ibuprofen	100 in 1 BOTTLE	TABLET	100	18
62207-366-46	Ibuprofen	250 in 1 BOTTLE	TABLET	250	18
62207-366-47	Ibuprofen	500 in 1 BOTTLE	TABLET	500	18
62207-366-48	Ibuprofen	750 in 1 BOTTLE	TABLET	750	18
62207-366-49	Ibuprofen	1000 in 1 BOTTLE	TABLET	1000	18
62207-366-51	Ibuprofen	10 in 1 BOTTLE	TABLET	10	18

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET [GRANULES INDIA LIMITED]	11
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET [GRANULES INDIA LIMITED]	11
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	IBUPROFEN TABLET [GRANULES INDIA LIMITED]	11
DEXTROSE MONOHYDRATE	INACTIVE INGREDIENT	LX22YL083G	IBUPROFEN TABLET [GRANULES INDIA LIMITED]	11
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	IBUPROFEN TABLET [GRANULES INDIA LIMITED]	11
HYPROMELLOSE 2208 (100 MPA.S)	INACTIVE INGREDIENT	B1QE5P712K	IBUPROFEN TABLET [GRANULES INDIA LIMITED]	11
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	IBUPROFEN TABLET [GRANULES INDIA LIMITED]	11
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	IBUPROFEN TABLET [GRANULES INDIA LIMITED]	11
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	IBUPROFEN TABLET [GRANULES INDIA LIMITED]	11
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	IBUPROFEN TABLET [GRANULES INDIA LIMITED]	11
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	IBUPROFEN TABLET [GRANULES INDIA LIMITED]	11
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	IBUPROFEN TABLET [GRANULES INDIA LIMITED]	11
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	IBUPROFEN TABLET [GRANULES INDIA LIMITED]	11
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	IBUPROFEN TABLET [GRANULES INDIA LIMITED]	11
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	IBUPROFEN TABLET [GRANULES INDIA LIMITED]	11
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	IBUPROFEN TABLET [GRANULES INDIA LIMITED]	11
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET [WESTERN FAMILY FOODS, INC.]	2
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET [WESTERN FAMILY FOODS, INC.]	2
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	IBUPROFEN TABLET [WESTERN FAMILY FOODS, INC.]	2
DEXTROSE MONOHYDRATE	INACTIVE INGREDIENT	LX22YL083G	IBUPROFEN TABLET [WESTERN FAMILY FOODS, INC.]	2
EGG PHOSPHOLIPIDS	INACTIVE INGREDIENT	1Z74184RGV	IBUPROFEN TABLET [WESTERN FAMILY FOODS, INC.]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	IBUPROFEN TABLET [WESTERN FAMILY FOODS, INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	IBUPROFEN TABLET [WESTERN FAMILY FOODS, INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	IBUPROFEN TABLET [WESTERN FAMILY FOODS, INC.]	2
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	IBUPROFEN TABLET [WESTERN FAMILY FOODS, INC.]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	IBUPROFEN TABLET [WESTERN FAMILY FOODS, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	IBUPROFEN TABLET [WESTERN FAMILY FOODS, INC.]	2
SODIUM STARCH GLYCOLATE TYPE A CORN	INACTIVE INGREDIENT	AG9B65PV6B	IBUPROFEN TABLET [WESTERN FAMILY FOODS, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	IBUPROFEN TABLET [WESTERN FAMILY FOODS, INC.]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	IBUPROFEN TABLET [WESTERN FAMILY FOODS, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	IBUPROFEN TABLET [WESTERN FAMILY FOODS, INC.]	2
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	IBUPROFEN TABLET [WESTERN FAMILY FOODS, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62207-366	IBUPROFEN TABLET [GRANULES INDIA LIMITED]	18	Current NDC, Legacy NDC, 8 package rows	20230131_fd01353d-1d1d-42b5-9a03-575052189bf5.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 · 70 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	Lidl US LLC	0ca02f8b-4413-4e7c-a67b-8c67c53e1343	2026-08-06	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
IBUPROFEN	IBUPROFEN	Harris Teeter	9d5c994a-8363-4ddb-956c-e12b79a32a58	2026-07-29	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Ibuprofen	IBUPROFEN	Harris Teeter	1fa28cb4-ae7b-4fa9-ae64-9bd8ccfcc633	2026-07-29	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Ibuprofen	IBUPROFEN	TWIN MED LLC	f03958f8-aeae-edf0-e053-2a95a90a3e9e	2026-07-22	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Ibuwin Forte	IBUPROFEN	OPMX LLC	0daf1be9-ea38-461e-e063-6394a90a7954	2026-07-15	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Ibuprofen	IBUPROFEN	Dr. Reddy's Laboratories Inc.	4d830b9b-b396-9581-7572-c7f19ff17597	2026-07-01	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Ibuprofen	IBUPROFEN	CHAIN DRUG MARKETING ASSOCIATION, INC.	68988a5b-7a6a-4ecd-8006-f2610bac2ad7	2026-06-08	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Ibuprofen	IBUPROFEN	Medline industries, LP	5d2482b4-cd90-4246-85a9-fd1d35315b6c	2026-06-04	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Ibuprofen	IBUPROFEN	Grocery Outlet, Inc.	441d762d-9022-426a-e063-6294a90a5076	2026-05-21	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
IBUPROFEN 200 MG	IBUPROFEN 200 MG	Farmacias De Similares TX LLC	441f7920-5666-5a3e-e063-6294a90a5583	2026-01-28	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Ibuprofen	IBUPROFEN	HYVEE INC	45aead8a-37ee-9a66-e063-6394a90a5d17	2026-01-13	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Xpect Ibuprofen	IBUPROFEN	Cintas Corporation	976ba88a-6428-40d1-a2fd-eac64963ba1d	2026-01-08	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Lil Drug Store Ibuprofen	IBUPROFEN	Lil Drug Store Products, Inc	29190ebf-bb9c-4406-be7b-4427741aeb74	2025-12-23	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Ibuprofen	IBUPROFEN	CVS	10424ad8-74fc-4f5f-e063-6394a90a13bd	2025-12-23	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Ibuprofen	IBUPROFEN	Granules USA, Inc.	8cb595d2-b7c2-687d-e053-2a95a90a5720	2025-12-22	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Ibuprofen	IBUPROFEN	Retail Business Services, LLC	04115ec1-ef31-1746-e063-6394a90a0a52	2025-12-19	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Ibuprofen	IBUPROFEN	RETAIL BUSINESS SERVICES,LLC.	a567dc6f-bd83-b9f5-e053-2995a90a05ee	2025-12-19	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Ibuprofen	IBUPROFEN	TOPCO ASSOCIATES LLC	1a00c17f-9766-deaa-e063-6394a90a8d60	2025-12-19	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
IBUPROFEN	IBUPROFEN	WALGREENS CO.	b8a77b7e-e161-b3ac-e053-2995a90af3e8	2025-12-19	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174
Ibuprofen	IBUPROFEN	Family Dollar	fe17f5a6-fd6d-d839-e053-6394a90a59a4	2025-12-19	Warnings	Exact identifier application applno (ANDA): 079174 application number: ANDA079174

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	fd01353d-1d1d-42b5-9a03-575052189bf5	18
310965	ibuprofen 200 MG Oral Tablet	SCD	fd01353d-1d1d-42b5-9a03-575052189bf5	18
310965	ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral Tablet	SY	fd01353d-1d1d-42b5-9a03-575052189bf5	18
310965	ibuprofen 200 MG Oral Tablet	PSN	baa437dd-b89d-44d9-9a05-543849933127	2
310965	ibuprofen 200 MG Oral Tablet	SCD	baa437dd-b89d-44d9-9a05-543849933127	2
310965	ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral Tablet	SY	baa437dd-b89d-44d9-9a05-543849933127	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Status
62207-366-26	62207036626	80000 TABLET in 1 BOX (62207-366-26)	80000 tablet	01-JAN-11	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ibuprofen Tablets, USP 200 mg	Granules India Limited \| GRANULES LIFE SCIENCES PRIVATE LIMITED	2024-08-13	HUMAN OTC DRUG LABEL	19
Ibuprofen Tablets USP 200 mg (Brown)	Granules India Limited	2023-12-14	BULK INGREDIENT	9
DRUG FACTS	Western Family Foods, Inc.	2012-10-09	HUMAN OTC DRUG LABEL	2