Clear Choice Ibuprofen

Product NDC: 53185-003
11-digit product format: 531850003
Labeler code: 53185
Product ID: 53185-003_40b9968a-8fd9-5ed9-e054-00144ff88e88
Type: HUMAN OTC DRUG
Nonproprietary name: IBUPROFEN
Dosage form: TABLET
Route: ORAL
Labeler: Athlete's Needs Inc
Application: ANDA079129
Marketing category: ANDA
Marketing start: 2012-10-09
Marketing end: 0000-00-00
Substance: IBUPROFEN
Active strength: 200 mg/1
NDC exclude flag: E
Listing certified through: 2017-12-31
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	53185-003		I	Inactivated by FDA		2026-08-17
excluded package	package	53185-003	53185-003-00	I	Inactivated by FDA		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 · 44 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		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53185-003-00	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53185-003-00	I	Inactivated by FDA	`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	53185-003-00	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	53185-003-00	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	53185-003-00	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	53185-003-00	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	53185-003-00	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	53185-003-00	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	53185-003-00	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	53185-003-00	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	53185-003-00	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	53185-003-00	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	53185-003-00	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	53185-003-00	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	53185-003-00	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	53185-003-00	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	53185-003-00	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	53185-003-00	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	53185-003-00	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	53185-003-00	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53185-003-00	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	53185-003-00	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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
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 · 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	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…`
2022-09-29 23:25 UTC	2022-09	A079129-001	IBUPROFEN	200MG	TABLET / ORAL	2011-03-28	`e64feba35796…`

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
874f4e63-49d2-5150-5d77-052172814ebd	Product name	6	20230105
557673c2-8256-b351-e863-4ec71a5a64b0	Product name	2	20160714
dbc9a339-6215-4e94-9546-57a3b34902ce	Product name	1	20160517
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53185-003-00	2020-01-31	C162847	48780-1	9d75b9d0-8ea8-f424-e053-dadaa90a57ce	Clear Choice Ibuprofen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53185-003-00	Clear Choice Ibuprofen	100 in 1 BOTTLE	TABLET	100		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	CLEAR CHOICE IBUPROFEN (IBUPROFEN) TABLET [ATHLETE'S NEEDS INC]	1
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	CLEAR CHOICE IBUPROFEN (IBUPROFEN) TABLET [ATHLETE'S NEEDS INC]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	CLEAR CHOICE IBUPROFEN (IBUPROFEN) TABLET [ATHLETE'S NEEDS INC]	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	CLEAR CHOICE IBUPROFEN (IBUPROFEN) TABLET [ATHLETE'S NEEDS INC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CLEAR CHOICE IBUPROFEN (IBUPROFEN) TABLET [ATHLETE'S NEEDS INC]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	CLEAR CHOICE IBUPROFEN (IBUPROFEN) TABLET [ATHLETE'S NEEDS INC]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CLEAR CHOICE IBUPROFEN (IBUPROFEN) TABLET [ATHLETE'S NEEDS INC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CLEAR CHOICE IBUPROFEN (IBUPROFEN) TABLET [ATHLETE'S NEEDS INC]	1
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	CLEAR CHOICE IBUPROFEN (IBUPROFEN) TABLET [ATHLETE'S NEEDS INC]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CLEAR CHOICE IBUPROFEN (IBUPROFEN) TABLET [ATHLETE'S NEEDS INC]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	CLEAR CHOICE IBUPROFEN (IBUPROFEN) TABLET [ATHLETE'S NEEDS INC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CLEAR CHOICE IBUPROFEN (IBUPROFEN) TABLET [ATHLETE'S NEEDS INC]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CLEAR CHOICE IBUPROFEN (IBUPROFEN) TABLET [ATHLETE'S NEEDS INC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CLEAR CHOICE IBUPROFEN (IBUPROFEN) TABLET [ATHLETE'S NEEDS INC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CLEAR CHOICE IBUPROFEN (IBUPROFEN) TABLET [ATHLETE'S NEEDS INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53185-003	CLEAR CHOICE IBUPROFEN (IBUPROFEN) TABLET [ATHLETE'S NEEDS INC]	2	Legacy NDC, 1 package rows	20161107_20bde9bd-7b13-4be4-9cba-ebc10c834a7a.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 1 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
IBUPROFEN Immediate Release	IBUPROFEN	Strides Pharma Inc	a5dd275f-f388-44ec-8297-74430a742d52	2026-03-24	Boxed warning, 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

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	20bde9bd-7b13-4be4-9cba-ebc10c834a7a	2
310965	ibuprofen 200 MG Oral Tablet	SCD	20bde9bd-7b13-4be4-9cba-ebc10c834a7a	2
310965	ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral Tablet	SY	20bde9bd-7b13-4be4-9cba-ebc10c834a7a	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
53185-003-00	53185000300	100 in 1 BOTTLE	Historical