Ibuprofen

Product NDC: 87441-044
Requested package NDC: 87441-044-01
11-digit product format: 874410044
Labeler code: 87441
Product ID: 87441-044_55156629-4e09-90ac-e063-6394a90a8a7f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ibuprofen
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Unit Dose Solutions, Inc.
Application: ANDA091625
Marketing category: ANDA
Marketing start: 2015-12-21
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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.

Product history page 1 of 4 · 129 observed 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
2026-09-14 22:38:34	2026-08	A091625-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2015-09-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091625-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2015-09-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091625-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2015-09-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091625-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2015-09-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091625-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2015-09-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091625-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2015-09-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091625-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2015-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091625-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2015-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091625-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2015-09-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091625-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2015-09-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091625-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2015-09-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091625-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2015-09-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091625-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2015-09-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091625-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2015-09-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091625-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2015-09-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091625-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2015-09-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091625-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2015-09-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091625-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2015-09-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091625-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2015-09-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091625-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2015-09-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091625-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2015-09-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091625-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2015-09-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091625-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2015-09-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091625-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2015-09-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091625-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2015-09-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091625-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2015-09-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091625-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2015-09-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091625-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2015-09-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091625-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2015-09-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091625-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2015-09-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091625-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2015-09-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091625-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2015-09-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091625-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2015-09-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091625-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2015-09-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091625-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2015-09-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091625-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2015-09-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091625-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2015-09-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091625-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2015-09-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091625-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2015-09-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091625-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2015-09-15	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A091625-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091625-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091625-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091625-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091625-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091625-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091625-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091625-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091625-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091625-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091625-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091625-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091625-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091625-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091625-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091625-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091625-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091625-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091625-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091625-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091625-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091625-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091625-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091625-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091625-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091625-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091625-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091625-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091625-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091625-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091625-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091625-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091625-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091625-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091625-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091625-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091625-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091625-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091625-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091625-001	AB	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197806	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
5515661b-6373-2191-e063-6294a90a17e0	Available on FDA.report

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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	REMEDYREPACK INC.	560e4e05-21e0-4b2a-ab2f-872b5dbb3901	2026-08-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091625 application number: ANDA091625
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 ndc (package): 87441-044-01 ndc (product): 87441-044 ndc11 (package): 87441004401
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	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

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
87441-044-01	87441004401	30 TABLET, FILM COATED in 1 BLISTER PACK (87441-044-01)	2026-06-25	No	No	Current