Ibuprofen

Product NDC: 65162-464
11-digit product format: 651620464
Labeler code: 65162
Product ID: 65162-464_32c8853c-ed52-4791-9350-ab724724d342
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ibuprofen
Dosage form: TABLET
Route: ORAL
Labeler: Amneal Pharmaceuticals LLC
Application: ANDA078558
Marketing category: ANDA
Marketing start: 2009-11-23
Substance: IBUPROFEN
Active strength: 400 mg/1
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Ingredient, Strength table
Ingredient	Strength
IBUPROFEN	400 mg/1

Field, Values table
Field	Values
Unii	WK2XYI10QM
Rxcui	197805, 197806, 197807

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

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65162-464-03	Ibuprofen	30 in 1 BOTTLE	TABLET	30	10
65162-464-06	Ibuprofen	60 in 1 BOTTLE	TABLET	60	10
65162-464-09	Ibuprofen	90 in 1 BOTTLE	TABLET	90	10
65162-464-10	Ibuprofen	100 in 1 BOTTLE	TABLET	100	10
65162-464-50	Ibuprofen	500 in 1 BOTTLE	TABLET	500	10

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65162-464-10	EA - Each	65162-464	65380f32-c7d3-4da2-b0a5-450215a8444d	1	2018-02-20
65162-464-50	EA - Each	65162-464	70d63c20-3ec1-4dd8-87ba-278599306a12	1	2018-02-20

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65162-464	IBUPROFEN TABLET [AMNEAL PHARMACEUTICALS LLC]	10	Current NDC, Legacy NDC, 5 package rows	20250123_17577b3b-e755-45d1-8b53-775d058578b2.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WK2XYI10QM	IBUPROFEN	15687-27-1	IBUPROFEN

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197805	ibuprofen 400 MG Oral Tablet	PSN	17577b3b-e755-45d1-8b53-775d058578b2	10
197806	ibuprofen 600 MG Oral Tablet	PSN	17577b3b-e755-45d1-8b53-775d058578b2	10
197807	ibuprofen 800 MG Oral Tablet	PSN	17577b3b-e755-45d1-8b53-775d058578b2	10
197805	ibuprofen 400 MG Oral Tablet	SCD	17577b3b-e755-45d1-8b53-775d058578b2	10
197806	ibuprofen 600 MG Oral Tablet	SCD	17577b3b-e755-45d1-8b53-775d058578b2	10
197807	ibuprofen 800 MG Oral Tablet	SCD	17577b3b-e755-45d1-8b53-775d058578b2	10
197805	ibuprofen 400 MG Oral Tablet	PSN	e080f7da-a506-4c04-a227-c1be77234f01	7
197806	ibuprofen 600 MG Oral Tablet	PSN	e080f7da-a506-4c04-a227-c1be77234f01	7
197807	ibuprofen 800 MG Oral Tablet	PSN	e080f7da-a506-4c04-a227-c1be77234f01	7
197805	ibuprofen 400 MG Oral Tablet	SCD	e080f7da-a506-4c04-a227-c1be77234f01	7
197806	ibuprofen 600 MG Oral Tablet	SCD	e080f7da-a506-4c04-a227-c1be77234f01	7
197807	ibuprofen 800 MG Oral Tablet	SCD	e080f7da-a506-4c04-a227-c1be77234f01	7
197805	ibuprofen 400 MG Oral Tablet	PSN	0b266934-da61-4dc9-e063-6294a90a5445	2
197805	ibuprofen 400 MG Oral Tablet	SCD	0b266934-da61-4dc9-e063-6294a90a5445	2
197805	ibuprofen 400 MG Oral Tablet	PSN	1a02fa34-b5ae-7183-e063-6294a90a3ae4	1
197805	ibuprofen 400 MG Oral Tablet	SCD	1a02fa34-b5ae-7183-e063-6294a90a3ae4	1

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65162-464-03	65162046403	30 TABLET in 1 BOTTLE (65162-464-03)	30 tablet	2009-11-23	0000-00-00	No	No	Current
65162-464-06	65162046406	60 TABLET in 1 BOTTLE (65162-464-06)	60 tablet	2009-11-23	0000-00-00	No	No	Current
65162-464-09	65162046409	90 TABLET in 1 BOTTLE (65162-464-09)	90 tablet	2009-11-23	0000-00-00	No	No	Current
65162-464-10	65162046410	100 TABLET in 1 BOTTLE (65162-464-10)	100 tablet	2009-11-23	0000-00-00	No	No	Current
65162-464-50	65162046450	500 TABLET in 1 BOTTLE (65162-464-50)	500 tablet	2009-11-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ibuprofen Tablets, USP 8444601/0825 Rx only	American Health Packaging	2025-09-19	HUMAN PRESCRIPTION DRUG LABEL	7
Ibuprofen Tablets, USP (400 mg Rx only	PD-Rx Pharmaceuticals, Inc.	2025-03-07	HUMAN PRESCRIPTION DRUG LABEL	16
Ibuprofen Tablets, USP (400 mg , 600 mg and 800 mg) Rx only	Amneal Pharmaceuticals LLC	2024-12-20	HUMAN PRESCRIPTION DRUG LABEL	10
Ibuprofen	Redpharm Drug	2024-07-24	HUMAN PRESCRIPTION DRUG LABEL	2
Ibuprofen 400 mg Tablets	Boswell Pharmacy Services LLC d/b/a BPS Wholesale	2024-06-03	HUMAN PRESCRIPTION DRUG LABEL	1