IBUPROFEN

Product NDC: 61919-463
Requested package NDC: 61919-463-72
11-digit product format: 619190463
Labeler code: 61919
Product ID: 61919-463_4c493c0f-6b6e-a79a-e063-6294a90a982d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: IBUOROFEN
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Direct_Rx
Application: ANDA091625
Marketing category: ANDA
Marketing start: 2019-08-22
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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.

Product history page 1 of 4 · 123 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
2026-02-19 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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091625-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2015-09-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091625-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2015-09-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091625-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2015-09-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091625-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2015-09-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091625-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2015-09-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091625-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2015-09-15	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091625-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091625-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091625-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091625-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091625-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091625-001	AB	1	`8072bd15b7f6…`

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 · 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
90b8b80e-ab30-3590-e053-2a95a90a70ef	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

FDA-Initiated Inactive NDC Indexing#

NDC, Indexing SPL, Related label table
NDC	Indexing SPL	Related label
61919-463-21	2cef2736-87e0-d83d-e063-dadaa90ab31f	IBUPROFEN
61919-463-30	2cef2736-8b20-d83d-e063-dadaa90ab31f	IBUPROFEN
61919-463-40	2cef2736-87e0-d83d-e063-dadaa90ab31f	IBUPROFEN
61919-463-45	2cef2736-87e0-d83d-e063-dadaa90ab31f	IBUPROFEN
61919-463-60	2cef2736-87e0-d83d-e063-dadaa90ab31f	IBUPROFEN
61919-463-71	2cef2736-87e0-d83d-e063-dadaa90ab31f	IBUPROFEN
61919-463-72	2cef2736-87e0-d83d-e063-dadaa90ab31f	IBUPROFEN
61919-463-90	2cef2736-87e0-d83d-e063-dadaa90ab31f	IBUPROFEN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61919-463-15	IBUPROFEN	15 in 1 BOTTLE	TABLET, FILM COATED	15	7
61919-463-21	IBUPROFEN	21 in 1 BOTTLE	TABLET, FILM COATED	21	7
61919-463-40	IBUPROFEN	40 in 1 BOTTLE	TABLET, FILM COATED	40	7
61919-463-45	IBUPROFEN	45 in 1 BOTTLE	TABLET, FILM COATED	45	7
61919-463-60	IBUPROFEN	60 in 1 BOTTLE	TABLET, FILM COATED	60	7
61919-463-71	IBUPROFEN	100 in 1 BOTTLE	TABLET, FILM COATED	100	7
61919-463-72	IBUPROFEN	120 in 1 BOTTLE	TABLET, FILM COATED	120	7
61919-463-90	IBUPROFEN	90 in 1 BOTTLE	TABLET, FILM COATED	90	7
61919-463-30	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
61919-463-15	EA - Each	61919-463	4396a988-b9e8-4f1e-8885-42a455cc8db8	1	2026-03-17
61919-463-21	EA - Each	61919-463	9d7f64f2-bf4d-4f9e-8340-2fce6bec4e88	1	2023-02-06
61919-463-30	EA - Each	61919-463	c8e5d4cc-7e06-4e91-a113-3ec23202c976	1	2018-04-19
61919-463-40	EA - Each	61919-463	64d0f986-3660-4ff8-874e-130d2c3688bc	1	2022-10-06
61919-463-45	EA - Each	61919-463	e96d8b12-909e-4e2d-8f4a-5eee8f63303f	1	2019-09-05
61919-463-60	EA - Each	61919-463	c82cd7f5-af58-4d29-8d79-29569b73317a	1	2022-10-06
61919-463-71	EA - Each	61919-463	8219b4a1-8270-4e90-b6cd-7c6c356e5cff	1	2022-10-06
61919-463-72	EA - Each	61919-463	e1223385-c71f-48c8-b02a-8df80fbeb532	1	2023-06-06
61919-463-90	EA - Each	61919-463	0e21dfea-580b-4100-a227-76dfedf79532	1	2022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-463	IBUPROFEN (IBUOROFEN) TABLET, FILM COATED [DIRECT_RX]	6	Current NDC, Legacy NDC, 8 package rows	20230419_90b8b80e-ab30-3590-e053-2a95a90a70ef.zip
61919-463	IBUPROFEN (IBUOROFEN) TABLET, FILM COATED IBUPROFEN TABLET, FILM COATED [DIRECT RX]	2	Current NDC, Legacy NDC, 1 package rows	20190330_67377024-fe71-4fa0-e053-2991aa0afba2.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	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 ndc (package): 61919-463-72 ndc (product): 61919-463 ndc11 (package): 61919046372
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
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
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	Sample	Exclude flag	Status
61919-463-72	61919046372	120 TABLET, FILM COATED in 1 BOTTLE (61919-463-72)	2019-08-22	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
IBUPROFEN	Direct_Rx	2026-03-05	HUMAN PRESCRIPTION DRUG LABEL	7
IBUPROFEN	DIRECT RX	2019-03-29	HUMAN PRESCRIPTION DRUG LABEL	2