Ibuprofen

Product NDC: 62207-357
11-digit product format: 622070357
Labeler code: 62207
Product ID: 62207-357_ba67be92-0460-58ae-e053-2995a90af488
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen
Dosage form: TABLET
Route: ORAL
Labeler: Granules India Limited
Application: ANDA202312
Marketing category: ANDA
Marketing start: 2016-11-17
Marketing end: 0000-00-00
Substance: IBUPROFEN
Active strength: 200 mg/1
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

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 · 9 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	62207-357		D	Discontinued by firm	2026-08-17
excluded package	package	62207-357	62207-357-41	D	Discontinued by firm	2026-08-17
excluded package	package	62207-357	62207-357-42	D	Discontinued by firm	2026-08-17
excluded package	package	62207-357	62207-357-43	D	Discontinued by firm	2026-08-17
excluded package	package	62207-357	62207-357-46	D	Discontinued by firm	2026-08-17
excluded package	package	62207-357	62207-357-47	D	Discontinued by firm	2026-08-17
excluded package	package	62207-357	62207-357-48	D	Discontinued by firm	2026-08-17
excluded package	package	62207-357	62207-357-49	D	Discontinued by firm	2026-08-17
excluded package	package	62207-357	62207-357-91	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 · 9 matching rows.

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

Dataset, Scope, Package NDC table
Dataset	Scope	Package NDC
excluded product	product
excluded package	package	62207-357-47
excluded package	package	62207-357-41
excluded package	package	62207-357-43
excluded package	package	62207-357-91
excluded package	package	62207-357-42
excluded package	package	62207-357-48
excluded package	package	62207-357-49
excluded package	package	62207-357-46

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
A202312-001	IBUPROFEN	IBUPROFEN	200MG	TABLET / ORAL			2016-10-07

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	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`e64feba35796…`

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62207-357	IBUPROFEN TABLET [GRANULES INDIA LIMITED]	10	Legacy NDC	20210204_b36c24b3-7bba-4698-a71c-ca617ea1060e.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 · 32 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	Shield Pharmaceuticals Corp	22102461-0196-4ef0-aef4-66997d74d118	2026-08-10	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312
Ibuprofen	IBUPROFEN	Harris Teeter	637210f0-6494-4656-8b2b-14d7476cb127	2026-07-29	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312
IBUPROFEN	IBUPROFEN	Harris Teeter	14515409-736f-4119-b6a0-cb19ee2e948e	2026-07-29	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312
IBUPROFEN	IBUPROFEN	Granules India Limited	97516b9f-219a-429d-850d-1fe9fd66646b	2026-06-15	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312
Ibuprofen	IBUPROFEN	HYVEE INC	459fc063-0664-09b7-e063-6394a90a89e0	2026-01-13	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312
Ibuprofen	IBUPROFEN	HYVEE INC	459fc670-32a3-61a6-e063-6294a90aea5a	2026-01-13	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312
Ibuprofen	IBUPROFEN	RETAIL BUSINESS SERVICES,LLC.	a568fd1e-9bf0-3c03-e053-2a95a90a45b7	2025-12-19	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312
Ibuprofen	IBUPROFEN	TOPCO ASSOCIATES LLC	1a00c85b-2ba5-32c3-e063-6294a90af148	2025-12-19	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312
Ibuprofen	IBUPROFEN	Walgreens	07edb8d0-2fa8-4b40-e063-6294a90a2fe9	2025-12-19	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312
Ibuprofen	IBUPROFEN	BETTER LIVING BRANDS LLC.	a3c1a61b-88fc-419c-e053-2a95a90ac0c3	2025-12-18	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312
Ibuprofen	IBUPROFEN	VALU MERCHANDISERS COMPANY	a42f96c4-322d-4714-9435-7b5a4e8b6ae5	2025-12-11	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312
Ibuprofen	IBUPROFEN	VALU MERCHANDISERS COMPANY	36b95840-f621-437a-bf49-406d320964da	2025-12-11	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312
Ibuprofen	IBUPROFEN	CHAIN DRUG MARKETING ASSOCIATION INC	9c1ded4e-1d3b-1ab6-e053-2995a90aa80d	2025-12-10	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312
Ibuprofen	IBUPROFEN	CHAIN DRUG MARKETING ASSOCIATION INC	9c1cc205-b9e3-03fc-e053-2995a90aaffb	2025-12-10	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312
IBUPROFEN	IBUPROFEN	RETAIL BUSINESS SERVICES , LLC.	8f9f40f5-625d-3f2e-e053-2a95a90a438b	2025-11-18	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312
Ibuprofen	IBUPROFEN	RETAIL BUSINESS SERVICES , LLC.	8f9f42a7-c2d8-4a51-e053-2a95a90a1677	2025-11-18	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312
Ibuprofen	IBUPROFEN	Demoulas Super Markets, Inc	39802e26-1028-d2fe-e063-6394a90a24c7	2025-07-16	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312
Ibuprofen	IBUPROFEN	Marc Glassman, Inc.	9714e804-fadb-103d-e053-2a95a90ad765	2025-07-15	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312
Ibuprofen	IBUPROFEN	MARC GLASSMAN, INC.	9714de6b-068b-d6b9-e053-2995a90a3b27	2025-07-15	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312
Ibuprofen	IBUPROFEN	United Natural Foods, Inc. dba UNFI	8fecb3a8-d288-cacf-e053-2a95a90ae238	2025-07-01	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WK2XYI10QM	IBUPROFEN	15687-27-1	IBUPROFEN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
62207-357-41	62207035741	24 TABLET in 1 BOTTLE (62207-357-41)	24 tablet	2016-11-17	0000-00-00	No	No	Current
62207-357-42	62207035742	50 TABLET in 1 BOTTLE (62207-357-42)	50 tablet	2016-11-17	0000-00-00	No	No	Current
62207-357-43	62207035743	100 TABLET in 1 BOTTLE (62207-357-43)	100 tablet	2016-11-17	0000-00-00	No	No	Current
62207-357-46	62207035746	250 TABLET in 1 BOTTLE (62207-357-46)	250 tablet	2016-11-17	0000-00-00	No	No	Current
62207-357-47	62207035747	500 TABLET in 1 BOTTLE (62207-357-47)	500 tablet	2016-11-17	0000-00-00	No	No	Current
62207-357-48	62207035748	750 TABLET in 1 BOTTLE (62207-357-48)	750 tablet	2016-11-17	0000-00-00	No	No	Current
62207-357-49	62207035749	1000 TABLET in 1 BOTTLE (62207-357-49)	1000 tablet	2016-11-17	0000-00-00	No	No	Current
62207-357-91	62207035791	160000 BAG in 1 DRUM (62207-357-91) > 1 TABLET in 1 BAG	160000 bag	2018-10-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ibuprofen Tablets, 200 mg	Granules India Limited \| Granules India Ltd	2021-02-02	HUMAN OTC DRUG LABEL	10