Ibuprofen

Product NDC: 65162-465
11-digit product format: 651620465
Labeler code: 65162
Product ID: 65162-465_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: 600 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A078558-001	IBUPROFEN	IBUPROFEN	400MG	TABLET / ORAL	AB	2007-06-18
A078558-002	IBUPROFEN	IBUPROFEN	600MG	TABLET / ORAL	AB	2007-06-18
A078558-003	IBUPROFEN	IBUPROFEN	800MG	TABLET / ORAL	AB	2007-06-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A078558-001	AB
A078558-002	AB
A078558-003	AB

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A078558-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2007-06-18	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078558-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2007-06-18	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078558-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2007-06-18	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A078558-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078558-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078558-003	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	Amneal Pharmaceuticals LLC	17577b3b-e755-45d1-8b53-775d058578b2	2026-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078558 application number: ANDA078558 ndc (product): 65162-465
Ibuprofen	IBUPROFEN	Cardinal Health 107, LLC	0387bfaa-daca-48ec-b718-0216a848c16a	2026-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078558 application number: ANDA078558
Ibuprofen	IBUPROFEN	PHOENIX RX LLC	40202c76-4275-88fd-e063-6394a90a07b2	2025-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078558 application number: ANDA078558
Ibuprofen	IBUPROFEN	American Health Packaging	e080f7da-a506-4c04-a227-c1be77234f01	2025-09-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078558 application number: ANDA078558
Ibuprofen	IBUPROFEN	Aphena Pharma Solutions - Tennessee, LLC	334e40f3-6da4-ecbe-e063-6294a90a35bf	2025-04-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078558 application number: ANDA078558
Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals,Inc.	fc871659-ce41-1be6-e053-6294a90aa5e4	2025-01-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078558 application number: ANDA078558
Ibuprofen	IBUPROFEN	Advanced Rx of Tennessee, LLC	af9af7f4-6314-6217-e053-2995a90a5a0f	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078558 application number: ANDA078558
Ibuprofen	IBUPROFEN	Amneal Pharmaceuticals of New York LLC	faebc392-0fd9-4c71-8471-beba10dda022	2024-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078558 application number: ANDA078558
Ibuprofen	IBUPROFEN	Boswell Pharmacy Services LLC d/b/a BPS Wholesale	1a02fa34-b5ae-7183-e063-6294a90a3ae4	2024-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078558 application number: ANDA078558
Ibuprofen	IBUPROFEN	Bryant Ranch Prepack	e90c573d-eb0f-45a5-94d1-efdd3d2b7a11	2024-01-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078558 application number: ANDA078558
Ibuprofen	IBUPROFEN	A-S Medication Solutions	fa99f5ec-0306-473b-827f-86cd0a7978ec	2023-08-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078558 application number: ANDA078558
Ibuprofen	IBUPROFEN	Proficient Rx LP	e4bb22bb-6df6-4016-a023-0b454df9fb0b	2023-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078558 application number: ANDA078558
Ibuprofen	IBUPROFEN	Proficient Rx LP	e23eb275-ce0c-40ec-b809-a48c5e46c7ec	2021-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078558 application number: ANDA078558

Additional Listing Data#

Finished product: Yes
Brand name base: Ibuprofen
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
IBUPROFEN	600 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
WK2XYI10QM	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197805	Internal RxNorm lookup
197806	Internal RxNorm lookup
197807	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
17577b3b-e755-45d1-8b53-775d058578b2	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65162-465-03	Ibuprofen	30 in 1 BOTTLE	TABLET	30	10
65162-465-05	Ibuprofen	50 in 1 BOTTLE	TABLET	50	10
65162-465-06	Ibuprofen	60 in 1 BOTTLE	TABLET	60	10
65162-465-09	Ibuprofen	90 in 1 BOTTLE	TABLET	90	10
65162-465-10	Ibuprofen	100 in 1 BOTTLE	TABLET	100	10
65162-465-50	Ibuprofen	500 in 1 BOTTLE	TABLET	500	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65162-465-10	EA - Each	65162-465	14383308-4b8c-4070-8b3d-b6b2afff9422	1	2018-02-20
65162-465-50	EA - Each	65162-465	8660d4d3-787a-487d-b5d4-c0b1fac1d6a9	1	2018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65162-465	IBUPROFEN TABLET [AMNEAL PHARMACEUTICALS LLC]	10	Current NDC, Legacy NDC, 6 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

DailyMed RxNorm Mappings#

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
197806	ibuprofen 600 MG Oral Tablet	PSN	b337640d-8f9f-b6ab-e053-2a95a90a5032	4
197806	ibuprofen 600 MG Oral Tablet	SCD	b337640d-8f9f-b6ab-e053-2a95a90a5032	4
197806	ibuprofen 600 MG Oral Tablet	PSN	b69df3b8-ec45-06a1-e053-2995a90acc82	2
197806	ibuprofen 600 MG Oral Tablet	SCD	b69df3b8-ec45-06a1-e053-2995a90acc82	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65162-465-03	65162046503	30 TABLET in 1 BOTTLE (65162-465-03)	30 tablet	2009-11-23	0000-00-00	No	No	Current
65162-465-05	65162046505	50 TABLET in 1 BOTTLE (65162-465-05)	50 tablet	2009-11-23	0000-00-00	No	No	Current
65162-465-06	65162046506	60 TABLET in 1 BOTTLE (65162-465-06)	60 tablet	2009-11-23	0000-00-00	No	No	Current
65162-465-09	65162046509	90 TABLET in 1 BOTTLE (65162-465-09)	90 tablet	2009-11-23	0000-00-00	No	No	Current
65162-465-10	65162046510	100 TABLET in 1 BOTTLE (65162-465-10)	100 tablet	2009-11-23	0000-00-00	No	No	Current
65162-465-50	65162046550	500 TABLET in 1 BOTTLE (65162-465-50)	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 (400 mg , 600 mg and 800 mg) Rx only	Amneal Pharmaceuticals LLC \| Amneal Pharmaceuticals Private Limited	2026-07-29	HUMAN PRESCRIPTION DRUG LABEL	11
Ibuprofen Tablets, USP 8444601/0825 Rx only	American Health Packaging	2025-09-19	HUMAN PRESCRIPTION DRUG LABEL	7
Ibuprofen Tablets, USP 600 mg Rx only	PD-Rx Pharmaceuticals, Inc.	2025-03-07	HUMAN PRESCRIPTION DRUG LABEL	19
Ibuprofen 600MG Tablets	RedPharm Drug, Inc. \| RedPharm Drug	2024-07-25	HUMAN PRESCRIPTION DRUG LABEL	4
Ibuprofen Tablets, USP (400 mg , 600 mg and 800 mg) Rx Only	NuCare Pharmaceuticals,Inc.	2022-01-14	HUMAN PRESCRIPTION DRUG LABEL	2