Ibuprofen

Product NDC: 54348-825
11-digit product format: 543480825
Labeler code: 54348
Product ID: 54348-825_eaa5b55d-10af-aab9-e053-2995a90a05d7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: IBUPROFEN
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: PharmPak, Inc.
Application: ANDA091625
Marketing category: ANDA
Marketing start: 2019-07-11
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

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
b493bf76-1e8b-4e72-bef6-aca4efc69cbe	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
54348-825-00	Ibuprofen	1 in 1 BOX	TABLET, FILM COATED	1	2
54348-825-00	Ibuprofen	1 in 1 BOTTLE	TABLET, FILM COATED	1	2
54348-825-06	Ibuprofen	1 in 1 BOX	TABLET, FILM COATED	1	2
54348-825-06	Ibuprofen	6 in 1 BOTTLE	TABLET, FILM COATED	6	2
54348-825-08	Ibuprofen	8 in 1 BOTTLE	TABLET, FILM COATED	8	2
54348-825-08	Ibuprofen	1 in 1 BOX	TABLET, FILM COATED	1	2
54348-825-09	Ibuprofen	9 in 1 BOTTLE	TABLET, FILM COATED	9	2
54348-825-09	Ibuprofen	1 in 1 BOX	TABLET, FILM COATED	1	2
54348-825-10	Ibuprofen	10 in 1 BOTTLE	TABLET, FILM COATED	10	2
54348-825-10	Ibuprofen	1 in 1 BOX	TABLET, FILM COATED	1	2
54348-825-12	Ibuprofen	1 in 1 BOX	TABLET, FILM COATED	1	2
54348-825-12	Ibuprofen	12 in 1 BOTTLE	TABLET, FILM COATED	12	2
54348-825-15	Ibuprofen	15 in 1 BOTTLE	TABLET, FILM COATED	15	2
54348-825-15	Ibuprofen	1 in 1 BOX	TABLET, FILM COATED	1	2
54348-825-20	Ibuprofen	20 in 1 BOTTLE	TABLET, FILM COATED	20	2
54348-825-20	Ibuprofen	1 in 1 BOX	TABLET, FILM COATED	1	2
54348-825-30	Ibuprofen	30 in 1 BOTTLE	TABLET, FILM COATED	30	2
54348-825-30	Ibuprofen	1 in 1 BOX	TABLET, FILM COATED	1	2
54348-825-60	Ibuprofen	60 in 1 BOTTLE	TABLET, FILM COATED	60	2
54348-825-60	Ibuprofen	1 in 1 BOX	TABLET, FILM COATED	1	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54348-825	IBUPROFEN TABLET, FILM COATED [PHARMPAK, INC.]	2	Current NDC, Legacy NDC, 20 package rows	20221011_b493bf76-1e8b-4e72-bef6-aca4efc69cbe.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
197807	ibuprofen 800 MG Oral Tablet	PSN	b493bf76-1e8b-4e72-bef6-aca4efc69cbe	2
197807	ibuprofen 800 MG Oral Tablet	SCD	b493bf76-1e8b-4e72-bef6-aca4efc69cbe	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
54348-825-00	54348082500	1 BOTTLE in 1 BOX (54348-825-00) / 1 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2019-07-11	0000-00-00	No	No	Current
54348-825-06	54348082506	1 BOTTLE in 1 BOX (54348-825-06) / 6 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2019-07-11	0000-00-00	No	No	Current
54348-825-08	54348082508	1 BOTTLE in 1 BOX (54348-825-08) / 8 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2019-07-11	0000-00-00	No	No	Current
54348-825-09	54348082509	1 BOTTLE in 1 BOX (54348-825-09) / 9 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2019-07-11	0000-00-00	No	No	Current
54348-825-10	54348082510	1 BOTTLE in 1 BOX (54348-825-10) / 10 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2019-07-11	0000-00-00	No	No	Current
54348-825-12	54348082512	1 BOTTLE in 1 BOX (54348-825-12) / 12 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2019-07-11	0000-00-00	No	No	Current
54348-825-15	54348082515	1 BOTTLE in 1 BOX (54348-825-15) / 15 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2019-07-11	0000-00-00	No	No	Current
54348-825-20	54348082520	1 BOTTLE in 1 BOX (54348-825-20) / 20 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2019-07-11	0000-00-00	No	No	Current
54348-825-30	54348082530	1 BOTTLE in 1 BOX (54348-825-30) / 30 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2019-07-11	0000-00-00	No	No	Current
54348-825-60	54348082560	1 BOTTLE in 1 BOX (54348-825-60) / 60 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2019-07-11	0000-00-00	No	No	Current