IBUPROFEN

Product NDC: 61919-628
Requested package NDC: 61919-628-21
11-digit product format: 619190628
Labeler code: 61919
Product ID: 61919-628_edad129d-d395-5999-e053-2a95a90a47f1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: IBUPROFEN
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Direct_Rx
Application: ANDA091625
Marketing category: ANDA
Marketing start: 2019-08-20
Marketing end: 0000-00-00
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: 2023-12-31
Current FDA listing: Historical FDA.report record

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
excluded package	package	61919-628	61919-628-21	I	Inactivated by FDA		2026-08-03

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

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
61919-628-21	2025-01-30	C162847	48780-1	2cef2736-b0c7-d83d-e063-dadaa90ab31f	IBUPROFEN
61919-628-30	2025-01-30	C162847	48780-1	2cef2736-8b20-d83d-e063-dadaa90ab31f	IBUPROFEN
61919-628-60	2025-01-30	C162847	48780-1	2cef2736-b0c7-d83d-e063-dadaa90ab31f	IBUPROFEN
61919-628-90	2025-01-30	C162847	48780-1	2cef2736-b0c7-d83d-e063-dadaa90ab31f	IBUPROFEN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61919-628-21	IBUPROFEN	21 in 1 BOTTLE	TABLET, FILM COATED	21	4
61919-628-60	IBUPROFEN	60 in 1 BOTTLE	TABLET, FILM COATED	60	4
61919-628-90	IBUPROFEN	90 in 1 BOTTLE	TABLET, FILM COATED	90	4
61919-628-30	IBUPROFEN	30 in 1 BOTTLE	TABLET, FILM COATED	30	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-628-21	EA - Each	61919-628	a3a67547-4a69-43b4-89d2-7cd1e656c759	1	2019-09-05
61919-628-30	EA - Each	61919-628	a78afcb2-87c0-40e4-9df7-dd65c05e732f	1	2019-04-11
61919-628-60	EA - Each	61919-628	0a00b310-5a22-445e-b060-54c1a0a71feb	1	2022-10-06
61919-628-90	EA - Each	61919-628	f3ee5e17-c10a-413c-bd6c-922d1ee63b9b	1	2022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-628	IBUPROFEN TABLET, FILM COATED [DIRECT_RX]	4	Legacy NDC, 3 package rows	20230510_908e2b06-f642-db7c-e053-2995a90a51a4.zip
61919-628	IBUPROFEN (IBUOROFEN) TABLET, FILM COATED IBUPROFEN TABLET, FILM COATED [DIRECT RX]	2	Legacy NDC, 1 package rows	20190330_67377024-fe71-4fa0-e053-2991aa0afba2.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
197806	ibuprofen 600 MG Oral Tablet	PSN	908e2b06-f642-db7c-e053-2995a90a51a4	4
197806	ibuprofen 600 MG Oral Tablet	SCD	908e2b06-f642-db7c-e053-2995a90a51a4	4
197806	ibuprofen 600 MG Oral Tablet	PSN	67377024-fe71-4fa0-e053-2991aa0afba2	2
197807	ibuprofen 800 MG Oral Tablet	PSN	67377024-fe71-4fa0-e053-2991aa0afba2	2
197806	ibuprofen 600 MG Oral Tablet	SCD	67377024-fe71-4fa0-e053-2991aa0afba2	2
197807	ibuprofen 800 MG Oral Tablet	SCD	67377024-fe71-4fa0-e053-2991aa0afba2	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-628-21	61919062821	21 TABLET, FILM COATED in 1 BOTTLE (61919-628-21)	2019-08-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
IBUPROFEN	Direct_Rx	2023-05-09	HUMAN PRESCRIPTION DRUG LABEL	4
IBUPROFEN	DIRECT RX	2019-03-29	HUMAN PRESCRIPTION DRUG LABEL	2