Ibuprofen

Product NDC: 65162-672
11-digit product format: 651620672
Labeler code: 65162
Product ID: 65162-672_010ab916-bc42-4e69-85d6-6585fc34226d
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen
Dosage form: SUSPENSION
Route: ORAL
Labeler: Amneal Pharmaceuticals
Application: ANDA200457
Marketing category: ANDA
Marketing start: 2011-11-12
Marketing end: 0000-00-00
Substance: IBUPROFEN
Active strength: 100 mg/5mL
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	65162-672		I	Inactivated by FDA		2026-08-11
excluded package	package	65162-672	65162-672-86	I	Inactivated by FDA		2026-08-11

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	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	65162-672-86	`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	65162-672-86	`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	65162-672-86	`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	65162-672-86	`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	65162-672-86	`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	65162-672-86	`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	65162-672-86	`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	65162-672-86	`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	65162-672-86	`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	65162-672-86	`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	65162-672-86	`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	65162-672-86	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	65162-672-86	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	65162-672-86	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	65162-672-86	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	65162-672-86	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	65162-672-86	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	65162-672-86	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	65162-672-86	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	65162-672-86	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	65162-672-86	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	65162-672-86	`110d247fa046…`	`a55b01930146…`

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
A200457-001	IBUPROFEN	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL			2011-08-18

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	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A200457-001	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	2011-08-18	`cb3db0bc1861…`

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
65162-672-86	2019-11-13	C162847	48780-1	97449f38-b636-f6ea-e053-dbdaa90aa703	Ibuprofen Oral Suspension, USP (NSAID) Pain Reliever/ Fever Reducer 100 mg/ 5 mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65162-672-86	IbuprofenPain Reliever/ Fever Reducer	118 mL in 1 BOTTLE	SUSPENSION	118		4
65162-672-86	IbuprofenPain Reliever/ Fever Reducer	1 in 1 CARTON	SUSPENSION	1		4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN PAIN RELIEVER/ FEVER REDUCER (IBUPROFEN) SUSPENSION [AMNEAL PHARMACEUTICALS]	4
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN PAIN RELIEVER/ FEVER REDUCER (IBUPROFEN) SUSPENSION [AMNEAL PHARMACEUTICALS]	4
ACESULFAME POTASSIUM	INACTIVE INGREDIENT	23OV73Q5G9	IBUPROFEN PAIN RELIEVER/ FEVER REDUCER (IBUPROFEN) SUSPENSION [AMNEAL PHARMACEUTICALS]	4
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	IBUPROFEN PAIN RELIEVER/ FEVER REDUCER (IBUPROFEN) SUSPENSION [AMNEAL PHARMACEUTICALS]	4
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	IBUPROFEN PAIN RELIEVER/ FEVER REDUCER (IBUPROFEN) SUSPENSION [AMNEAL PHARMACEUTICALS]	4
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	IBUPROFEN PAIN RELIEVER/ FEVER REDUCER (IBUPROFEN) SUSPENSION [AMNEAL PHARMACEUTICALS]	4
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	IBUPROFEN PAIN RELIEVER/ FEVER REDUCER (IBUPROFEN) SUSPENSION [AMNEAL PHARMACEUTICALS]	4
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	IBUPROFEN PAIN RELIEVER/ FEVER REDUCER (IBUPROFEN) SUSPENSION [AMNEAL PHARMACEUTICALS]	4
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	IBUPROFEN PAIN RELIEVER/ FEVER REDUCER (IBUPROFEN) SUSPENSION [AMNEAL PHARMACEUTICALS]	4
SUCROSE	INACTIVE INGREDIENT	C151H8M554	IBUPROFEN PAIN RELIEVER/ FEVER REDUCER (IBUPROFEN) SUSPENSION [AMNEAL PHARMACEUTICALS]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	IBUPROFEN PAIN RELIEVER/ FEVER REDUCER (IBUPROFEN) SUSPENSION [AMNEAL PHARMACEUTICALS]	4
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	IBUPROFEN PAIN RELIEVER/ FEVER REDUCER (IBUPROFEN) SUSPENSION [AMNEAL PHARMACEUTICALS]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65162-672	IBUPROFEN PAIN RELIEVER/ FEVER REDUCER (IBUPROFEN) SUSPENSION [AMNEAL PHARMACEUTICALS]	4	Legacy NDC, 2 package rows	20120222_ae1cb9ae-9d01-47f0-b9ec-0d924d913514.zip

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
197803	ibuprofen 100 MG in 5 mL Oral Suspension	PSN	ae1cb9ae-9d01-47f0-b9ec-0d924d913514	4
197803	ibuprofen 20 MG/ML Oral Suspension	SCD	ae1cb9ae-9d01-47f0-b9ec-0d924d913514	4
197803	ibuprofen 100 MG per 5 ML Oral Suspension	SY	ae1cb9ae-9d01-47f0-b9ec-0d924d913514	4
197803	ibuprofen 200 MG per 10 ML Oral Suspension	SY	ae1cb9ae-9d01-47f0-b9ec-0d924d913514	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
65162-672-86	65162067286	118 mL in 1 BOTTLE	118 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ibuprofen Oral Suspension, USP (NSAID) Pain Reliever/ Fever Reducer 100 mg/ 5 mL	Amneal Pharmaceuticals	2012-02-21	HUMAN OTC DRUG LABEL	4