Ibuprofen

Product NDC: 70518-2902
11-digit product format: 705182902
Labeler code: 70518
Product ID: 70518-2902_503587fe-bff9-1089-e063-6294a90af099
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ibuprofen
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA202413
Marketing category: ANDA
Marketing start: 2020-10-06
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

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
excluded package	package	70518-2902	70518-2902-0	D	Discontinued by firm		2026-08-17

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-2902-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-2902-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70518-2902-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70518-2902-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70518-2902-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70518-2902-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70518-2902-0	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70518-2902-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70518-2902-0	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70518-2902-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70518-2902-0	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70518-2902-0	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A202413-001	IBUPROFEN	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23
A202413-002	IBUPROFEN	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23
A202413-003	IBUPROFEN	IBUPROFEN	800MG	TABLET / ORAL	AB	2016-11-23
A202413-004	IBUPROFEN	IBUPROFEN	300MG	TABLET / ORAL		2024-07-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A202413-001	AB
A202413-002	AB
A202413-003	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 · 139 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
2026-08-18 06:07:40	2026-07	A202413-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202413-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202413-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2016-11-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202413-004	IBUPROFEN	300MG	TABLET / ORAL		2024-07-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202413-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202413-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202413-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2016-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202413-004	IBUPROFEN	300MG	TABLET / ORAL		2024-07-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202413-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202413-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202413-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2016-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202413-004	IBUPROFEN	300MG	TABLET / ORAL		2024-07-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202413-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202413-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202413-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2016-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202413-004	IBUPROFEN	300MG	TABLET / ORAL		2024-07-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202413-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202413-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202413-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2016-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202413-004	IBUPROFEN	300MG	TABLET / ORAL		2024-07-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202413-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202413-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202413-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2016-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202413-004	IBUPROFEN	300MG	TABLET / ORAL		2024-07-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202413-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202413-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202413-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2016-11-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202413-004	IBUPROFEN	300MG	TABLET / ORAL		2024-07-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202413-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202413-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202413-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2016-11-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202413-004	IBUPROFEN	300MG	TABLET / ORAL		2024-07-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202413-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202413-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202413-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2016-11-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202413-004	IBUPROFEN	300MG	TABLET / ORAL		2024-07-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202413-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2016-11-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202413-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2016-11-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202413-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2016-11-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202413-004	IBUPROFEN	300MG	TABLET / ORAL		2024-07-05	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A202413-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202413-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202413-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202413-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202413-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202413-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202413-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202413-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202413-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202413-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202413-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202413-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202413-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202413-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202413-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202413-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202413-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202413-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202413-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202413-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202413-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202413-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202413-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202413-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202413-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202413-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202413-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202413-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202413-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202413-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202413-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202413-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202413-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202413-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202413-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202413-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202413-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202413-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202413-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202413-001	AB	1	`1e350fbaab3a…`

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
2572ed69-d5a7-4513-a202-aca3230e7ec5	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#

Effective, Related label table
Effective	Related label
2022-02-09	Ibuprofen Tablets, USP 300 mg, 400 mg, 600 mg and 800 mg
2022-02-09	Ibuprofen Tablets, USP 300 mg, 400 mg, 600 mg and 800 mg
2022-01-28	Ibuprofen Tablets, USP 300 mg, 400 mg, 600 mg and 800 mg
2022-01-28	Ibuprofen Tablets, USP 300 mg, 400 mg, 600 mg and 800 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70518-2902-0	Ibuprofen	30 in 1 BLISTER PACK	TABLET, FILM COATED	30	5
70518-2902-1	Ibuprofen	50 in 1 BOX	TABLET, FILM COATED	50	5
70518-2902-2	Ibuprofen	1 in 1 POUCH	TABLET, FILM COATED	1	5

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 · 44 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	AiPing Pharmaceutical, Inc.	3e131710-2579-446e-8076-f602ecea813f	2026-08-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	PD-Rx Pharmaceuticals, Inc.	3a38add6-a114-4e18-836c-3bfc727db231	2026-08-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	REMEDYREPACK INC.	2572ed69-d5a7-4513-a202-aca3230e7ec5	2026-07-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413 ndc (product): 70518-2902
Ibuprofen	IBUPROFEN	PD-Rx Pharmaceuticals, Inc.	656658cc-8cf0-42b6-af4f-4e3ab7648625	2026-07-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	Preferred Pharmaceuticals Inc.	c0156053-add5-4bd5-b89f-f90df2e73be4	2026-07-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	Redpharm Drug	5302291e-4816-8495-e063-6394a90a9cc0	2026-05-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	REMEDYREPACK INC.	404df13d-4ada-4324-9eed-e21f5d5043a4	2026-04-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	ST. MARY'S MEDICAL PARK PHARMACY	4e67aef4-c3ac-232a-e063-6394a90a3a85	2026-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	Bryant Ranch Prepack	886c974c-0d32-4a1b-8f54-40c2c12efa45	2026-04-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals, Inc.	2e0f74a5-b8f3-fc81-e063-6394a90a647a	2026-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	Proficient Rx LP	ab2f1a30-611b-41b6-9baf-6a82305da845	2026-03-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals, Inc.	4b34b58b-2cf7-9aa8-e063-6294a90a0658	2026-02-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	A-S Medication Solutions	0170876a-d8cd-4a2d-8397-db2acdf72ffb	2026-02-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	Preferred Pharmaceuticals Inc.	70e191ef-8fad-49eb-9850-fceea119e92f	2026-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	Preferred Pharmaceuticals Inc.	b84ea215-e61d-4c00-8a34-d47c4080779b	2026-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	Coupler LLC	4831785a-cde2-79a2-e063-6294a90a9a40	2026-01-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	Chartwell RX, LLC	39f2664f-6c0a-4726-85d7-4227530d4a49	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	Redpharm Drug	44f278ac-6bf9-6aef-e063-6394a90a0bb6	2025-12-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	Redpharm Drug	44f5743f-8c98-dc4d-e063-6294a90a6dfa	2025-12-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413
Ibuprofen	IBUPROFEN	Redpharm Drug	44f609dd-c868-493f-e063-6294a90a7138	2025-12-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202413 application number: ANDA202413

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	2572ed69-d5a7-4513-a202-aca3230e7ec5	5
197806	ibuprofen 600 MG Oral Tablet	SCD	2572ed69-d5a7-4513-a202-aca3230e7ec5	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-2902-0	70518290200	30 TABLET, FILM COATED in 1 BLISTER PACK (70518-2902-0)		2020-10-06	0000-00-00	No	No	Current
70518-2902-1	70518290201	50 POUCH in 1 BOX (70518-2902-1) / 1 TABLET, FILM COATED in 1 POUCH (70518-2902-2)	50 pouch	2026-04-23		No	No	Current
70518-2902-2	70518290202	1 in 1 POUCH						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ibuprofen Tablets, USP 300 mg, 400 mg, 600 mg and 800 mg	REMEDYREPACK INC.	2026-07-30	HUMAN PRESCRIPTION DRUG LABEL	6