Ibuprofen

Product NDC: 62207-356
Requested package NDC: 62207-356-65
11-digit product format: 622070356
Labeler code: 62207
Product ID: 62207-356_44dee7dd-17ff-8faa-e063-6294a90a6712
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ibuprofen
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Granules India Limited
Application: ANDA091625
Marketing category: ANDA
Marketing start: 2015-09-21
Substance: IBUPROFEN
Active strength: 800 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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
unfinished package	package	62207-356	62207-356-65	UNFINISHED	Active or certified unfinished drug listing		2026-07-31

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
A091625-001	IBUPROFEN	IBUPROFEN	400MG	TABLET / ORAL	AB	2015-09-15
A091625-002	IBUPROFEN	IBUPROFEN	600MG	TABLET / ORAL	AB	2015-09-15
A091625-003	IBUPROFEN	IBUPROFEN	800MG	TABLET / ORAL	AB	2015-09-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091625-001	AB
A091625-002	AB
A091625-003	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	A091625-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2015-09-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A091625-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2015-09-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A091625-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2015-09-15	`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	A091625-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A091625-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A091625-003	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 3 · 41 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	PD-Rx Pharmaceuticals, Inc.	d3a7ebef-f7ab-4b34-b62e-278a8deabf78	2026-07-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091625 application number: ANDA091625
Ibuprofen	IBUPROFEN	PD-Rx Pharmaceuticals, Inc.	b81c6495-8b30-41ef-8a0f-4cbfd87f1eb4	2026-07-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091625 application number: ANDA091625
Ibuprofen	IBUPROFEN	PD-Rx Pharmaceuticals, Inc.	0cb73c19-a7cb-4ad9-9aa5-c24afb80d6d8	2026-07-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091625 application number: ANDA091625
Ibuprofen	IBUPROFEN	REMEDYREPACK INC.	57a1bf99-5aaf-432d-86ba-5f0e7cfab1a0	2026-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091625 application number: ANDA091625
Ibuprofen	IBUPROFEN	Bryant Ranch Prepack	f1c88d74-09b0-4b14-baea-106fbbbc54bf	2026-07-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091625 application number: ANDA091625
Ibuprofen	IBUPROFEN	REMEDYREPACK INC.	b6a6c940-daf6-4e0e-aefb-35cce87a9a55	2026-07-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091625 application number: ANDA091625
Ibuprofen	IBUPROFEN	REMEDYREPACK INC.	421156d2-85dc-4680-b2b4-d15b67539e87	2026-07-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091625 application number: ANDA091625
Ibuprofen	IBUPROFEN	REMEDYREPACK INC.	20078671-536f-4b0b-a079-f90ac186a670	2026-07-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091625 application number: ANDA091625
Ibuprofen	IBUPROFEN	REMEDYREPACK INC.	1e6f3ce7-e8a3-40e8-8437-523ef5277b2e	2026-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091625 application number: ANDA091625
Ibuprofen	IBUPROFEN	Unit Dose Solutions, Inc.	5515661b-6373-2191-e063-6294a90a17e0	2026-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091625 application number: ANDA091625
Ibuprofen	IBUPROFEN	A-S Medication Solutions	b40f39e4-a37c-4039-ae37-210c1c3c6235	2026-06-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091625 application number: ANDA091625
Ibuprofen	IBUPROFEN	A-S Medication Solutions	51de1183-d226-4869-a00a-f6c74e126a39	2026-06-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091625 application number: ANDA091625
Ibuprofen	IBUPROFEN	A-S Medication Solutions	25a94943-9acc-49c8-a4da-7e07bb2c35eb	2026-06-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091625 application number: ANDA091625
Ibuprofen	IBUPROFEN	Northwind Health Company, LLC	ab80abe6-f7db-479b-e053-2a95a90a90e3	2026-06-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091625 application number: ANDA091625
Ibuprofen	IBUPROFEN	Ascend Laboratories, LLC	9ce036ef-a22d-4fca-9a62-1b10978f7b26	2026-06-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091625 application number: ANDA091625
Ibuprofen	IBUPROFEN	REMEDYREPACK INC.	560e4e05-21e0-4b2a-ab2f-872b5dbb3901	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091625 application number: ANDA091625
Ibuprofen	IBUPROFEN	QPharma Inc	fd8b82a7-96fe-8bf5-e053-6394a90a3935	2026-05-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091625 application number: ANDA091625
Ibuprofen	IBUPROFEN	Granules Pharmaceuticals Inc.	4aefcb3a-5dc8-b88e-e063-6294a90ac044	2026-05-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091625 application number: ANDA091625
IBUPROFEN	IBUOROFEN	Direct_Rx	90b8b80e-ab30-3590-e053-2a95a90a70ef	2026-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091625 application number: ANDA091625
Ibuprofen	IBUPROFEN	Legacy Pharmaceutical Packaging, LLC	5ca441f9-a4b4-4bd8-aa54-319fae4c3d1a	2026-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091625 application number: ANDA091625

Additional Listing Data#

Finished product: Yes
Brand name base: Ibuprofen
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
IBUPROFEN	800 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
8804564c-9e1b-43c1-8b58-fd6ace645f00	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
62207-356-42	Ibuprofen	50 in 1 BOTTLE	TABLET, FILM COATED	50	24
62207-356-43	Ibuprofen	100 in 1 BOTTLE	TABLET, FILM COATED	100	24
62207-356-47	Ibuprofen	500 in 1 BOTTLE	TABLET, FILM COATED	500	24
62207-356-49	Ibuprofen	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	24
62207-356-54	Ibuprofen	30 in 1 BOTTLE	TABLET, FILM COATED	30	24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET, FILM COATED [GRANULES INDIA LIMITED]	6
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET, FILM COATED [GRANULES INDIA LIMITED]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	IBUPROFEN TABLET, FILM COATED [GRANULES INDIA LIMITED]	6
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	IBUPROFEN TABLET, FILM COATED [GRANULES INDIA LIMITED]	6
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	IBUPROFEN TABLET, FILM COATED [GRANULES INDIA LIMITED]	6
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	IBUPROFEN TABLET, FILM COATED [GRANULES INDIA LIMITED]	6
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	IBUPROFEN TABLET, FILM COATED [GRANULES INDIA LIMITED]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	IBUPROFEN TABLET, FILM COATED [GRANULES INDIA LIMITED]	6
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	IBUPROFEN TABLET, FILM COATED [GRANULES INDIA LIMITED]	6
POVIDONE K90	INACTIVE INGREDIENT	RDH86HJV5Z	IBUPROFEN TABLET, FILM COATED [GRANULES INDIA LIMITED]	6
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	IBUPROFEN TABLET, FILM COATED [GRANULES INDIA LIMITED]	6
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	IBUPROFEN TABLET, FILM COATED [GRANULES INDIA LIMITED]	6
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	IBUPROFEN TABLET, FILM COATED [GRANULES INDIA LIMITED]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	IBUPROFEN TABLET, FILM COATED [GRANULES INDIA LIMITED]	6
WATER	INACTIVE INGREDIENT	059QF0KO0R	IBUPROFEN TABLET, FILM COATED [GRANULES INDIA LIMITED]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62207-356	IBUPROFEN TABLET, FILM COATED [GRANULES INDIA LIMITED]	23	Current NDC, Legacy NDC, 5 package rows	20240719_8804564c-9e1b-43c1-8b58-fd6ace645f00.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	8804564c-9e1b-43c1-8b58-fd6ace645f00	24
197806	ibuprofen 600 MG Oral Tablet	PSN	8804564c-9e1b-43c1-8b58-fd6ace645f00	24
197807	ibuprofen 800 MG Oral Tablet	PSN	8804564c-9e1b-43c1-8b58-fd6ace645f00	24
197805	ibuprofen 400 MG Oral Tablet	SCD	8804564c-9e1b-43c1-8b58-fd6ace645f00	24
197806	ibuprofen 600 MG Oral Tablet	SCD	8804564c-9e1b-43c1-8b58-fd6ace645f00	24
197807	ibuprofen 800 MG Oral Tablet	SCD	8804564c-9e1b-43c1-8b58-fd6ace645f00	24

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Status
62207-356-65	62207035665	11400 TABLET, FILM COATED in 1 BOX (62207-356-65)	24-MAR-22	Current