Ibuprofen

Product NDC: 61715-018
11-digit product format: 617150018
Labeler code: 61715
Product ID: 61715-018_202ac623-305a-4005-bf14-ee5c4f276d0f
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen
Dosage form: TABLET
Route: ORAL
Labeler: Kinray
Application: ANDA091355
Marketing category: ANDA
Marketing start: 2011-11-22
Marketing end: 0000-00-00
Substance: IBUPROFEN
Active strength: 200 mg/1
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	61715-018		D	Discontinued by firm	2026-08-07
excluded package	package	61715-018	61715-018-50	D	Discontinued by firm	2026-08-07
excluded package	package	61715-018	61715-018-51	D	Discontinued by firm	2026-08-07

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 2 · 63 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61715-018-51	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61715-018-50	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61715-018-51	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61715-018-50	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61715-018-51	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61715-018-50	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61715-018-51	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61715-018-50	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61715-018-51	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61715-018-50	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61715-018-51	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61715-018-50	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61715-018-51	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61715-018-50	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61715-018-51	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61715-018-50	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61715-018-51	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61715-018-50	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61715-018-51	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61715-018-50	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61715-018-51	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61715-018-50	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61715-018-51	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61715-018-50	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	61715-018-51	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	61715-018-50	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	61715-018-51	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	61715-018-50	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	61715-018-51	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	61715-018-50	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	61715-018-51	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	61715-018-50	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	61715-018-51	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	61715-018-50	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	61715-018-51	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	61715-018-50	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	61715-018-51	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	61715-018-50	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	61715-018-51	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	61715-018-50	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`

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
A091355-001	IBUPROFEN	IBUPROFEN	200MG	TABLET / ORAL			2011-04-04

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	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`cb3db0bc1861…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
61715-018-50	2025-05-21	Drug Facts
61715-018-51	2025-05-21	Drug Facts
61715-018-50	2020-01-31	Drug Facts
61715-018-51	2020-01-31	Drug Facts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN (IBUPROFEN) TABLET [KINRAY]	1
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN (IBUPROFEN) TABLET [KINRAY]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	IBUPROFEN (IBUPROFEN) TABLET [KINRAY]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	IBUPROFEN (IBUPROFEN) TABLET [KINRAY]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	IBUPROFEN (IBUPROFEN) TABLET [KINRAY]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	IBUPROFEN (IBUPROFEN) TABLET [KINRAY]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	IBUPROFEN (IBUPROFEN) TABLET [KINRAY]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	IBUPROFEN (IBUPROFEN) TABLET [KINRAY]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	IBUPROFEN (IBUPROFEN) TABLET [KINRAY]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	IBUPROFEN (IBUPROFEN) TABLET [KINRAY]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	IBUPROFEN (IBUPROFEN) TABLET [KINRAY]	1
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	IBUPROFEN (IBUPROFEN) TABLET [KINRAY]	1

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	NUVICARE LLC	b063d2dc-d579-46e7-8cfc-1596c803c7f9	2026-07-29	Warnings	Exact identifier application applno (ANDA): 091355 application number: ANDA091355
Ibuprofen	IBUPROFEN	Pioneer Life Sciences, LLC	291602fa-8ebe-4200-bba7-9798c90f8a50	2026-07-29	Warnings	Exact identifier application applno (ANDA): 091355 application number: ANDA091355
Ibuprofen Immediate Release	IBUPROFEN	Strides Pharma Inc	ebcc4da3-d0f6-4e40-99b5-e88310ea4a5b	2024-05-23	Boxed warning, Warnings	Exact identifier application applno (ANDA): 091355 application number: ANDA091355
Ibuprofen Immediate Release	IBUPROFEN	Strides Pharma Inc.	1f4159ad-d58c-4519-932b-030cc2735514	2017-05-26	Warnings	Exact identifier application applno (ANDA): 091355 application number: ANDA091355