Ibuprofen

Product NDC: 37205-670
11-digit product format: 372050670
Labeler code: 37205
Product ID: 37205-670_dfb1fd20-8cb2-4440-80a4-d464d12fd9b8
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: CARDINAL HEALTH
Application: ANDA075010
Marketing category: ANDA
Marketing start: 1988-05-24
Marketing end: 0000-00-00
Substance: IBUPROFEN
Active strength: 200 mg/1
NDC exclude flag: No
Listing certified through: 2020-12-31
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	37205-670		D	Discontinued by firm	2026-08-03
excluded package	package	37205-670	37205-670-85	D	Discontinued by firm	2026-08-03
excluded package	package	37205-670	37205-670-90	D	Discontinued by firm	2026-08-03

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	37205-670-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	37205-670-85	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	37205-670-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	37205-670-85	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	37205-670-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	37205-670-85	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	37205-670-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	37205-670-85	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	37205-670-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	37205-670-85	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	37205-670-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	37205-670-85	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	37205-670-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	37205-670-85	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	37205-670-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	37205-670-85	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	37205-670-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	37205-670-85	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	37205-670-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	37205-670-85	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	37205-670-90	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	37205-670-85	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	37205-670-90	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	37205-670-85	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A075010-001	IBUPROFEN	IBUPROFEN	200MG	TABLET / ORAL			1999-03-01

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	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075010-001	IBUPROFEN	200MG	TABLET / ORAL	1999-03-01	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
37205-670-85	EA - Each	37205-670	15cd5f0b-24e1-482c-b84d-269091e2d3cd	1	2017-03-06
37205-670-90	EA - Each	37205-670	bb77103a-306e-45c3-84ff-3f04336bb4c9	1	2017-06-15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET [CARDINAL HEALTH]	1
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET [CARDINAL HEALTH]	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	IBUPROFEN TABLET [CARDINAL HEALTH]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	IBUPROFEN TABLET [CARDINAL HEALTH]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	IBUPROFEN TABLET [CARDINAL HEALTH]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	IBUPROFEN TABLET [CARDINAL HEALTH]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	IBUPROFEN TABLET [CARDINAL HEALTH]	1
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	IBUPROFEN TABLET [CARDINAL HEALTH]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	IBUPROFEN TABLET [CARDINAL HEALTH]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	IBUPROFEN TABLET [CARDINAL HEALTH]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	IBUPROFEN TABLET [CARDINAL HEALTH]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	IBUPROFEN TABLET [CARDINAL HEALTH]	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 3 · 53 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	Topco Associates, LLC	59a88ca7-eb37-46de-9134-a5a6d330bd49	2026-06-23	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Ibuprofen	IBUPROFEN	L.N.K. International, Inc.	57b39311-bc20-ace6-75a9-a07a9311b373	2026-06-09	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Ibuprofen	IBUPROFEN	Rite Aid Corporation	d9e698f3-c450-4eaa-9cfd-6f48c2656081	2026-06-09	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Ibuprofen	IBUPROFEN	ARMY AND AIR FORCE EXCHANGE SERVICE	718a4b73-5f46-4676-afda-f0b4819f5862	2026-06-09	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Ibuprofen	IBUPROFEN	Wal-Mart Stores Inc	cb897d65-7e98-4d02-be64-0704416a0f29	2026-05-28	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Ibuprofen	IBUPROFEN	Salado Sales, Inc.	06bc4445-5c80-4dd3-b1bb-d9244f45f570	2026-05-20	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Ibuprofen	IBUPROFEN	H E B	4805977f-a30b-4f86-9ef5-e66ad6b8bd53	2026-05-06	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Ibuprofen	IBUPROFEN	ARMY AND AIR FORCE EXCHANGE SERVICE	4a0c744f-4ad8-445e-bab1-7ffee35bf861	2026-05-06	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Medique at Home Iprin	IBUPROFEN	Sportpharm LLC	954d0436-b681-4bf5-80ec-0de9ddcab994	2026-04-24	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Ibuprofen	IBUPROFEN	COSTCO WHOLESALE CORPORATION	a50abf26-d6e5-10e4-ea90-a40b96a887e5	2026-04-13	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Ibuprofen	IBUPROFEN	Discount Drug Mart	cffad7af-44f5-4e54-9e46-c3c5d4ca182f	2026-04-08	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Ibuprofen	IBUPROFEN	Lidl US LLC	b840e98e-be1b-496f-9f0d-3a1a55eb9fe4	2026-04-08	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Ibuprofen	IBUPROFEN	L.N.K. International, Inc.	0ef4913b-5dc3-45bc-9cef-58601f8d2a79	2026-04-07	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Ibuprofen	IBUPROFEN	Walgreen Company	86818ad6-fd45-4635-9ce8-eac986f008aa	2026-03-11	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Ibuprofen	IBUPROFEN	Discount Drug Mart	d0ebf2a7-551b-4acd-be60-2d0b936dd703	2026-03-11	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Pain Relief Ibuprofen	IBUPROFEN	Rite Aid Corporation	c85c3d1f-7639-4cfa-bf3a-424b61757b1a	2026-02-03	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Ibuprofen	IBUPROFEN	CVS Pharmacy	8d9f11a5-ca98-4280-9c6a-093d32e60ace	2026-01-22	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Ibuprofen	IBUPROFEN	L.N.K. International, Inc.	d3b8d35a-10b5-a31c-8ced-eeb100c0fd7c	2026-01-12	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Ibuprofen	IBUPROFEN	Meijer Distribution Inc	c0c64ba5-b6b0-4221-9e44-110d92c93782	2026-01-12	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010
Ibuprofen	IBUPROFEN	DOLGENCORP, LLC	37ccb303-c70e-48b3-a8a3-2b0097cf8f88	2026-01-05	Warnings	Exact identifier application applno (ANDA): 075010 application number: ANDA075010