Ibutab

Product NDC: 35418-750
11-digit product format: 354180750
Labeler code: 35418
Product ID: 35418-750_a933ce6e-bf00-4b98-997f-92e250b95814
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen
Dosage form: TABLET
Route: ORAL
Labeler: Zee Medical Inc
Application: ANDA079129
Marketing category: ANDA
Marketing start: 2012-06-12
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	35418-750		D	Discontinued by firm		2026-09-14
excluded package	package	35418-750	35418-750-69	D	Discontinued by firm		2026-09-14

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 · 32 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	35418-750-69	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	35418-750-69	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	35418-750-69	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	35418-750-69	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	35418-750-69	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	35418-750-69	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	35418-750-69	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	35418-750-69	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	35418-750-69	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	35418-750-69	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	35418-750-69	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	35418-750-69	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
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	35418-750-69	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	35418-750-69	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	35418-750-69	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	35418-750-69	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A079129-001	IBUPROFEN	IBUPROFEN	200MG	TABLET / ORAL			2011-03-28

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`f41ea6bd6efb…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
35418-750-69	2023-12-05	C162847	48780-1	ba0f9c33-4776-a910-e053-dadaa90a0b85	Drug Facts
35418-750-69	2021-01-29	C162847	48780-1	ba0f9c33-4776-a910-e053-dadaa90a0b85	Drug Facts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUTAB (IBUPROFEN) TABLET [ZEE MEDICAL INC]	1
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUTAB (IBUPROFEN) TABLET [ZEE MEDICAL INC]	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	IBUTAB (IBUPROFEN) TABLET [ZEE MEDICAL INC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	IBUTAB (IBUPROFEN) TABLET [ZEE MEDICAL INC]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	IBUTAB (IBUPROFEN) TABLET [ZEE MEDICAL INC]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	IBUTAB (IBUPROFEN) TABLET [ZEE MEDICAL INC]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	IBUTAB (IBUPROFEN) TABLET [ZEE MEDICAL INC]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	IBUTAB (IBUPROFEN) TABLET [ZEE MEDICAL INC]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	IBUTAB (IBUPROFEN) TABLET [ZEE MEDICAL INC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	IBUTAB (IBUPROFEN) TABLET [ZEE MEDICAL INC]	1
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	IBUTAB (IBUPROFEN) TABLET [ZEE MEDICAL INC]	1
POLYETHYLENE GLYCOL 300	INACTIVE INGREDIENT	5655G9Y8AQ	IBUTAB (IBUPROFEN) TABLET [ZEE MEDICAL INC]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	IBUTAB (IBUPROFEN) TABLET [ZEE MEDICAL INC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	IBUTAB (IBUPROFEN) TABLET [ZEE MEDICAL INC]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	IBUTAB (IBUPROFEN) TABLET [ZEE MEDICAL INC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	IBUTAB (IBUPROFEN) TABLET [ZEE MEDICAL INC]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	IBUTAB (IBUPROFEN) TABLET [ZEE MEDICAL INC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	IBUTAB (IBUPROFEN) TABLET [ZEE MEDICAL INC]	1
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	IBUTAB (IBUPROFEN) TABLET [ZEE MEDICAL INC]	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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
IBUPROFEN Immediate Release	IBUPROFEN	Strides Pharma Inc	a5dd275f-f388-44ec-8297-74430a742d52	2026-09-02	Boxed warning, Warnings	Exact identifier application applno (ANDA): 079129 application number: ANDA079129
Ibuprofen	IBUPROFEN	P & L Development, LLC	159b68b7-54e5-4f83-b632-f49e7b4b14a5	2026-08-05	Warnings	Exact identifier application applno (ANDA): 079129 application number: ANDA079129
Ibuprofen	IBUPROFEN	Pioneer Life Sciences, LLC	8abd74a4-ad33-4c10-b677-acb469f815e6	2026-08-03	Warnings	Exact identifier application applno (ANDA): 079129 application number: ANDA079129
Ibuprofen	IBUPROFEN	NUVICARE LLC	7905edc1-2a45-4adc-a7bc-42b1ddb6ba59	2026-08-03	Warnings	Exact identifier application applno (ANDA): 079129 application number: ANDA079129
Ibuprofen	IBUPROFEN	Family Dollar (FAMILY WELLNESS)	5beb7c11-4ed4-4cd4-9c30-3b0c4016316f	2026-05-27	Warnings	Exact identifier application applno (ANDA): 079129 application number: ANDA079129
Ibuprofen	IBUPROFEN	Family Dollar (FAMILY WELLNESS)	da16b1a9-0db2-4f2f-bc85-05ea5ab26e1c	2026-05-27	Warnings	Exact identifier application applno (ANDA): 079129 application number: ANDA079129
CVS Ibuprofen	IBUPROFEN	CVS Pharmacy	3d71e29f-0648-7377-e063-6294a90a8a29	2026-02-17	Warnings	Exact identifier application applno (ANDA): 079129 application number: ANDA079129
Ibuprofen	IBUPROFEN	Strategic Sourcing Services, LLC	dc469eb2-89cc-46c9-9304-f6cf119c0570	2026-01-29	Warnings	Exact identifier application applno (ANDA): 079129 application number: ANDA079129
Ibuprofen	IBUPROFEN	AAA Pharmaceutical, Inc.	fbc7fb61-d295-464b-9f3b-52262ed6f31a	2025-12-09	Warnings	Exact identifier application applno (ANDA): 079129 application number: ANDA079129
RIGHT REMEDIES Ibuprofen 200 MG	IBUPROFEN	Strive Pharmaceuticals Inc.	5c155210-d16f-487e-983d-c7b0f97365c6	2025-10-08	Warnings	Exact identifier application applno (ANDA): 079129 application number: ANDA079129
Ibuprofen	IBUPROFEN	AAA Pharmaceutical, Inc.	39e55ec1-213f-4996-adca-68a5ffbc409b	2024-12-06	Warnings	Exact identifier application applno (ANDA): 079129 application number: ANDA079129
Ibuprofen	IBUPROFEN	P & L Development, LLC	6d1c9a64-c83c-4b3d-9245-704b94cb367c	2024-07-30	Warnings	Exact identifier application applno (ANDA): 079129 application number: ANDA079129
Ibuprofen, Circle K, 50ct	IBUPROFEN	Lil' Drug Store Products, Inc.	1ab6fbae-ead5-283b-e063-6394a90a4ed4	2024-06-12	Warnings	Exact identifier application applno (ANDA): 079129 application number: ANDA079129
Ibuprofen	IBUPROFEN	Family Dollar (FAMILY WELLNESS)	eaa0a286-a0f0-4979-8af3-c5f4194283fd	2023-06-22	Warnings	Exact identifier application applno (ANDA): 079129 application number: ANDA079129
Flex-Prin	IBUPROFEN	Provision Medical Products	c01538b0-ca4c-434a-be8f-fe023deb84e1	2023-01-05	Warnings	Exact identifier application applno (ANDA): 079129 application number: ANDA079129
Ibuprofen Fast relief medicine for pain	IBUPROFEN 200 MG	Allegiant Health	dd63b011-0573-4374-9669-8d29146e5fc9	2017-11-17	Warnings	Exact identifier application applno (ANDA): 079129 application number: ANDA079129