Ibuprofen

Product NDC: 67877-321
Requested package NDC: 67877-321-27
11-digit product format: 678770321
Labeler code: 67877
Product ID: 67877-321_8050d9d9-0b0b-4136-be37-a824114f7ea0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ibuprofen
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Ascend Laboratories, LLC
Application: ANDA091625
Marketing category: ANDA
Marketing start: 2015-12-21
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: 2027-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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	67877-321	67877-321-27	UNFINISHED	Active or certified unfinished drug listing		2026-09-14

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	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
9ce036ef-a22d-4fca-9a62-1b10978f7b26	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
67877-321-01	Ibuprofen	100 in 1 BOTTLE	TABLET, FILM COATED	100	9
67877-321-05	Ibuprofen	500 in 1 BOTTLE	TABLET, FILM COATED	500	9
67877-321-27	Ibuprofen	11400 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK	TABLET, FILM COATED	11400	9
67877-321-30	Ibuprofen	30 in 1 BOTTLE	TABLET, FILM COATED	30	9
67877-321-50	Ibuprofen	50 in 1 BOTTLE	TABLET, FILM COATED	50	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67877-321-01	EA - Each	67877-321	badbd35a-56d9-4946-be55-4e29e1014668	1	2016-05-16
67877-321-05	EA - Each	67877-321	c7bc4e4f-8b87-4054-9182-71a85d0ae80a	1	2016-06-14
67877-321-30	EA - Each	67877-321	90516d5e-45be-4e55-af12-be0cf06c351b	1	2017-06-15
67877-321-50	EA - Each	67877-321	f4a95c2f-23c7-4863-8d6c-90cce2e4164f	1	2017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67877-321	IBUPROFEN TABLET, FILM COATED [ASCEND LABORATORIES, LLC]	8	Current NDC, Legacy NDC, 5 package rows	20210323_9ce036ef-a22d-4fca-9a62-1b10978f7b26.zip

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
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 ndc (product): 67877-321
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197805	ibuprofen 400 MG Oral Tablet	PSN	51de1183-d226-4869-a00a-f6c74e126a39	55
197806	ibuprofen 600 MG Oral Tablet	PSN	51de1183-d226-4869-a00a-f6c74e126a39	55
197807	ibuprofen 800 MG Oral Tablet	PSN	51de1183-d226-4869-a00a-f6c74e126a39	55
197805	ibuprofen 400 MG Oral Tablet	SCD	51de1183-d226-4869-a00a-f6c74e126a39	55
197806	ibuprofen 600 MG Oral Tablet	SCD	51de1183-d226-4869-a00a-f6c74e126a39	55
197807	ibuprofen 800 MG Oral Tablet	SCD	51de1183-d226-4869-a00a-f6c74e126a39	55
197805	ibuprofen 400 MG Oral Tablet	PSN	fd691a4a-8010-45e6-b3da-b26374792f24	44
197807	ibuprofen 800 MG Oral Tablet	PSN	fd691a4a-8010-45e6-b3da-b26374792f24	44
197805	ibuprofen 400 MG Oral Tablet	SCD	fd691a4a-8010-45e6-b3da-b26374792f24	44
197807	ibuprofen 800 MG Oral Tablet	SCD	fd691a4a-8010-45e6-b3da-b26374792f24	44
197807	ibuprofen 800 MG Oral Tablet	PSN	8553e29a-7f6f-4ff8-9991-836e619c504d	41
197807	ibuprofen 800 MG Oral Tablet	SCD	8553e29a-7f6f-4ff8-9991-836e619c504d	41
197807	ibuprofen 800 MG Oral Tablet	PSN	0cb73c19-a7cb-4ad9-9aa5-c24afb80d6d8	18
197807	ibuprofen 800 MG Oral Tablet	PSN	421156d2-85dc-4680-b2b4-d15b67539e87	18
197807	ibuprofen 800 MG Oral Tablet	SCD	421156d2-85dc-4680-b2b4-d15b67539e87	18
197807	ibuprofen 800 MG Oral Tablet	SCD	0cb73c19-a7cb-4ad9-9aa5-c24afb80d6d8	18
197807	ibuprofen 800 MG Oral Tablet	PSN	560e4e05-21e0-4b2a-ab2f-872b5dbb3901	17
197807	ibuprofen 800 MG Oral Tablet	SCD	560e4e05-21e0-4b2a-ab2f-872b5dbb3901	17
197805	ibuprofen 400 MG Oral Tablet	PSN	a4c74188-9af6-422c-abd9-087a8ab4b43a	12
197806	ibuprofen 600 MG Oral Tablet	PSN	a4c74188-9af6-422c-abd9-087a8ab4b43a	12
197807	ibuprofen 800 MG Oral Tablet	PSN	a4c74188-9af6-422c-abd9-087a8ab4b43a	12
197805	ibuprofen 400 MG Oral Tablet	SCD	a4c74188-9af6-422c-abd9-087a8ab4b43a	12
197806	ibuprofen 600 MG Oral Tablet	SCD	a4c74188-9af6-422c-abd9-087a8ab4b43a	12
197807	ibuprofen 800 MG Oral Tablet	SCD	a4c74188-9af6-422c-abd9-087a8ab4b43a	12
197807	ibuprofen 800 MG Oral Tablet	PSN	b81c6495-8b30-41ef-8a0f-4cbfd87f1eb4	11
197807	ibuprofen 800 MG Oral Tablet	SCD	b81c6495-8b30-41ef-8a0f-4cbfd87f1eb4	11
197807	ibuprofen 800 MG Oral Tablet	PSN	af9ac948-440c-5abf-e053-2995a90af2b5	10
197807	ibuprofen 800 MG Oral Tablet	SCD	af9ac948-440c-5abf-e053-2995a90af2b5	10
197805	ibuprofen 400 MG Oral Tablet	PSN	9ce036ef-a22d-4fca-9a62-1b10978f7b26	9
197806	ibuprofen 600 MG Oral Tablet	PSN	5ca441f9-a4b4-4bd8-aa54-319fae4c3d1a	9
197806	ibuprofen 600 MG Oral Tablet	PSN	9ce036ef-a22d-4fca-9a62-1b10978f7b26	9
197807	ibuprofen 800 MG Oral Tablet	PSN	5ca441f9-a4b4-4bd8-aa54-319fae4c3d1a	9
197807	ibuprofen 800 MG Oral Tablet	PSN	9ce036ef-a22d-4fca-9a62-1b10978f7b26	9
197805	ibuprofen 400 MG Oral Tablet	SCD	9ce036ef-a22d-4fca-9a62-1b10978f7b26	9
197806	ibuprofen 600 MG Oral Tablet	SCD	5ca441f9-a4b4-4bd8-aa54-319fae4c3d1a	9
197806	ibuprofen 600 MG Oral Tablet	SCD	9ce036ef-a22d-4fca-9a62-1b10978f7b26	9
197807	ibuprofen 800 MG Oral Tablet	SCD	9ce036ef-a22d-4fca-9a62-1b10978f7b26	9
197807	ibuprofen 800 MG Oral Tablet	SCD	5ca441f9-a4b4-4bd8-aa54-319fae4c3d1a	9
197807	ibuprofen 800 MG Oral Tablet	PSN	90b8b80e-ab30-3590-e053-2a95a90a70ef	7
197807	ibuprofen 800 MG Oral Tablet	SCD	90b8b80e-ab30-3590-e053-2a95a90a70ef	7
197807	ibuprofen 800 MG Oral Tablet	PSN	4cfa7cec-81e6-6c0a-e054-00144ff8d46c	6
197807	ibuprofen 800 MG Oral Tablet	PSN	2dc3108f-d917-40c6-865d-c900cf055d1c	6
197807	ibuprofen 800 MG Oral Tablet	PSN	d0198bdc-fe2b-4b09-8f78-9e5a7f6ae784	6
197807	ibuprofen 800 MG Oral Tablet	PSN	ab80abe6-f7db-479b-e053-2a95a90a90e3	6
197807	ibuprofen 800 MG Oral Tablet	SCD	4cfa7cec-81e6-6c0a-e054-00144ff8d46c	6
197807	ibuprofen 800 MG Oral Tablet	SCD	2dc3108f-d917-40c6-865d-c900cf055d1c	6
197807	ibuprofen 800 MG Oral Tablet	SCD	d0198bdc-fe2b-4b09-8f78-9e5a7f6ae784	6
197807	ibuprofen 800 MG Oral Tablet	SCD	ab80abe6-f7db-479b-e053-2a95a90a90e3	6
197807	ibuprofen 800 MG Oral Tablet	PSN	888a5dbc-9464-e272-e053-2a95a90ad687	4
197807	ibuprofen 800 MG Oral Tablet	PSN	2f12a20c-4293-d18a-e063-6294a90a3afc	4
197807	ibuprofen 800 MG Oral Tablet	SCD	888a5dbc-9464-e272-e053-2a95a90ad687	4
197807	ibuprofen 800 MG Oral Tablet	SCD	2f12a20c-4293-d18a-e063-6294a90a3afc	4
197806	ibuprofen 600 MG Oral Tablet	PSN	57ec3a3f-b5ac-3a97-e053-2a91aa0a788f	2
197806	ibuprofen 600 MG Oral Tablet	PSN	67377024-fe71-4fa0-e053-2991aa0afba2	2
197807	ibuprofen 800 MG Oral Tablet	PSN	34885247-d379-4c3c-b891-b02f31a203b5	2
197807	ibuprofen 800 MG Oral Tablet	PSN	b493bf76-1e8b-4e72-bef6-aca4efc69cbe	2
197807	ibuprofen 800 MG Oral Tablet	PSN	67377024-fe71-4fa0-e053-2991aa0afba2	2
197807	ibuprofen 800 MG Oral Tablet	PSN	57ec3a3f-b5ac-3a97-e053-2a91aa0a788f	2
197807	ibuprofen 800 MG Oral Tablet	PSN	6637efdc-996a-75b9-e053-2a91aa0a9046	2
197806	ibuprofen 600 MG Oral Tablet	SCD	67377024-fe71-4fa0-e053-2991aa0afba2	2
197806	ibuprofen 600 MG Oral Tablet	SCD	57ec3a3f-b5ac-3a97-e053-2a91aa0a788f	2
197807	ibuprofen 800 MG Oral Tablet	SCD	57ec3a3f-b5ac-3a97-e053-2a91aa0a788f	2
197807	ibuprofen 800 MG Oral Tablet	SCD	b493bf76-1e8b-4e72-bef6-aca4efc69cbe	2
197807	ibuprofen 800 MG Oral Tablet	SCD	34885247-d379-4c3c-b891-b02f31a203b5	2
197807	ibuprofen 800 MG Oral Tablet	SCD	67377024-fe71-4fa0-e053-2991aa0afba2	2
197807	ibuprofen 800 MG Oral Tablet	SCD	6637efdc-996a-75b9-e053-2a91aa0a9046	2
197807	ibuprofen 800 MG Oral Tablet	PSN	bc06d982-d670-ef05-e053-2a95a90a973a	1
197807	ibuprofen 800 MG Oral Tablet	PSN	e4644cb5-7fae-456a-98d3-62ba521cd0b2	1
197807	ibuprofen 800 MG Oral Tablet	PSN	7d786d5e-3864-daba-e053-2991aa0ab629	1
197807	ibuprofen 800 MG Oral Tablet	SCD	bc06d982-d670-ef05-e053-2a95a90a973a	1
197807	ibuprofen 800 MG Oral Tablet	SCD	7d786d5e-3864-daba-e053-2991aa0ab629	1
197807	ibuprofen 800 MG Oral Tablet	SCD	e4644cb5-7fae-456a-98d3-62ba521cd0b2	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
67877-321-27	67877032127	11400 TABLET, FILM COATED in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK (67877-321-27)	2017-04-14	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
IBUPROFEN Tablets, USP	REMEDYREPACK INC.	2026-08-04	HUMAN PRESCRIPTION DRUG LABEL	18
IBUPROFEN Tablets, USP	PD-Rx Pharmaceuticals, Inc.	2026-07-21	HUMAN PRESCRIPTION DRUG LABEL	12
IBUPROFEN Tablets, USP	PD-Rx Pharmaceuticals, Inc.	2026-07-20	HUMAN PRESCRIPTION DRUG LABEL	19
IBUPROFEN Tablets, USP	REMEDYREPACK INC.	2026-07-17	HUMAN PRESCRIPTION DRUG LABEL	18
IBUPROFEN Tablets, USP	REMEDYREPACK INC.	2026-07-06	HUMAN PRESCRIPTION DRUG LABEL	19
IBUPROFEN Tablets, USP	A-S Medication Solutions	2026-06-23	Human Prescription Drug Label	57
IBUPROFEN Tablets, USP	Northwind Health Company, LLC	2026-06-12	HUMAN PRESCRIPTION DRUG LABEL	7
IBUPROFEN Tablets, USP	Ascend Laboratories, LLC \| Granules India Limited	2026-06-05	Human Prescription Drug Label	10
IBUPROFEN Tablets, USP	Legacy Pharmaceutical Packaging, LLC	2026-03-05	HUMAN PRESCRIPTION DRUG LABEL	9
IBUPROFEN	Direct_Rx	2026-03-05	HUMAN PRESCRIPTION DRUG LABEL	7
IBUPROFEN Tablets, USP	Northwind Health Company, LLC	2026-01-02	HUMAN PRESCRIPTION DRUG LABEL	4
Ibuprofen Tablets	Advanced Rx of Tennessee, LLC	2025-08-07	HUMAN PRESCRIPTION DRUG LABEL	10