Ibuprofen

Product NDC: 59651-360
11-digit product format: 596510360
Labeler code: 59651
Product ID: 59651-360_5e595111-8477-4ec7-8d32-a0aeabc04e1a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ibuprofen
Dosage form: TABLET
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA213794
Marketing category: ANDA
Marketing start: 2020-05-08
Substance: IBUPROFEN
Active strength: 400 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: 2026-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
unfinished product	product	59651-360		UNFINISHED	Active or certified unfinished drug listing		2026-08-07
unfinished package	package	59651-360	59651-360-23	UNFINISHED	Active or certified unfinished drug listing		2026-08-07

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 · 32 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 21:27 UTC · source 2025-12-05	unfinished product	product		`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	59651-360-23	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished product	product		`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	59651-360-23	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished product	product		`390b4c401c3f…`	`2c692c2daee3…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	59651-360-23	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished product	product		`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	59651-360-23	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished product	product		`bbbc9f937eca…`	`946b9c97cf81…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	59651-360-23	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished product	product		`f268b84574a6…`	`26285f5ac5df…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	59651-360-23	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished product	product		`f764e8902f78…`	`92046438deef…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	59651-360-23	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished product	product		`68b1e3bced9e…`	`98a755eb8bc6…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished package	package	59651-360-23	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished product	product		`05c55d027831…`	`ca05dca9dc4c…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished package	package	59651-360-23	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished product	product		`48b4f40e6753…`	`c7c7a00d2afa…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished package	package	59651-360-23	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished product	product		`27f29a85d7e4…`	`1372111e901f…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished package	package	59651-360-23	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished product	product		`8d62ce987f31…`	`9fe9ef23e30d…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished package	package	59651-360-23	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished product	product		`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished package	package	59651-360-23	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished product	product		`50b4072663b7…`	`eae3003ed65e…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished package	package	59651-360-23	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished product	product		`906f6e251498…`	`bf70b80e44f0…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished package	package	59651-360-23	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished product	product		`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished package	package	59651-360-23	`6db9cb8d1e19…`	`3449e1ec5b70…`

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
A213794-001	IBUPROFEN	IBUPROFEN	400MG	TABLET / ORAL	AB	2020-05-08
A213794-002	IBUPROFEN	IBUPROFEN	600MG	TABLET / ORAL	AB	2020-05-08
A213794-003	IBUPROFEN	IBUPROFEN	800MG	TABLET / ORAL	AB	2020-05-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213794-001	AB
A213794-002	AB
A213794-003	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 3 · 111 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	A213794-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2020-05-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213794-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2020-05-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213794-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2020-05-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213794-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2020-05-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213794-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2020-05-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213794-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2020-05-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213794-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2020-05-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213794-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2020-05-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213794-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2020-05-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213794-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2020-05-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213794-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2020-05-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213794-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2020-05-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213794-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2020-05-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213794-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2020-05-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213794-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2020-05-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213794-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2020-05-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213794-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2020-05-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213794-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2020-05-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213794-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2020-05-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213794-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2020-05-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213794-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2020-05-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213794-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2020-05-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213794-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2020-05-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213794-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2020-05-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213794-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2020-05-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213794-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2020-05-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213794-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2020-05-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213794-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2020-05-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213794-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2020-05-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213794-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2020-05-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213794-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2020-05-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213794-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2020-05-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213794-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2020-05-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213794-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2020-05-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213794-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2020-05-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213794-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2020-05-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213794-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2020-05-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213794-002	IBUPROFEN	600MG	TABLET / ORAL	AB	2020-05-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213794-003	IBUPROFEN	800MG	TABLET / ORAL	AB	2020-05-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213794-001	IBUPROFEN	400MG	TABLET / ORAL	AB	2020-05-08	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 111 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	A213794-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213794-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213794-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213794-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213794-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213794-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213794-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213794-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213794-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213794-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213794-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213794-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213794-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213794-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213794-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213794-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213794-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213794-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213794-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213794-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213794-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213794-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213794-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213794-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213794-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213794-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213794-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213794-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213794-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213794-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213794-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213794-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213794-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213794-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213794-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213794-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213794-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213794-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213794-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213794-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Ibuprofen
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
IBUPROFEN	400 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
00872852-680a-41b3-901b-b991b12a176d	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
16cde546-8deb-4df2-a072-dab5566ede95	Product name	1	20231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015	Product name	4	20230808
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
874f4e63-49d2-5150-5d77-052172814ebd	Product name	6	20230105
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
557673c2-8256-b351-e863-4ec71a5a64b0	Product name	2	20160714
dbc9a339-6215-4e94-9546-57a3b34902ce	Product name	1	20160517
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
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
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59651-360-01	Ibuprofen	100 in 1 BOTTLE	TABLET	100		6
59651-360-05	Ibuprofen	500 in 1 BOTTLE	TABLET	500		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59651-360-01	EA - Each	59651-360	35c7599c-52f8-4141-8999-478c3ea83992	1	2021-01-08
59651-360-05	EA - Each	59651-360	07232d8a-a6d2-4e9c-bbce-74dd417b9bc9	1	2021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59651-360	IBUPROFEN TABLET [AUROBINDO PHARMA LIMITED]	6	Current NDC, Legacy NDC, 2 package rows	20250216_00872852-680a-41b3-901b-b991b12a176d.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 2 · 38 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	St. Mary's Medical Park Pharmacy	0a98cce4-f5c0-12a8-e063-6294a90a4e7e	2026-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	Proficient Rx LP	34a9b94f-93ba-4a7c-92eb-d0b4b530d887	2026-07-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	HAWAII REPACK, INC.	6239818c-747d-4cbb-9b41-27ca8bbce41b	2026-06-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	Sportpharm LLC	cef04ae4-e78a-454d-bb66-84b1d348c106	2026-06-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	Unit Dose Solutions, Inc.	5515e80f-7513-b425-e063-6294a90aa542	2026-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	REMEDYREPACK INC.	2fa4bfc8-386c-433b-bc46-24fc8ec1bca1	2026-06-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	REMEDYREPACK INC.	ec6b2df4-2f4f-4601-8b53-0542664e0bd9	2026-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	Preferred Pharmaceuticals Inc.	bdc3f482-6fba-4420-9118-0f5cb7744e97	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	Preferred Pharmaceuticals Inc.	13fd4401-1821-4f2b-a44e-96aa2fa75b5c	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	Preferred Pharmaceuticals Inc.	25d9f5fc-4d95-4018-add8-ba696b6079b2	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals,Inc.	05ce8e8e-0b25-061e-e063-6394a90a2e92	2026-05-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	Coupler LLC	50766a3d-1a22-be14-e063-6294a90a0ed2	2026-04-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	NorthStar Rx LLC	aeee629b-255c-40d8-8e95-779aec00f723	2026-03-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	Direct_Rx	1aa11b52-1aca-9219-e063-6294a90a470f	2026-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	A-S Medication Solutions	f24582be-8d70-4848-bd54-e55fa28f394f	2025-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	A-S Medication Solutions	e5db46f3-043b-40ac-a89b-c90bd562e7b4	2025-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	A-S Medication Solutions	3db0c659-cc43-45dc-8442-bc89093d94d7	2025-12-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals,Inc.	f60445d3-807e-0bbf-e053-2995a90a1299	2025-10-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	A-S Medication Solutions	8d5f7d2a-af48-4d47-8bf5-48f01c092d24	2025-10-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794
Ibuprofen	IBUPROFEN	A-S Medication Solutions	4b75bd6f-5455-4237-991c-eacc0fdcf709	2025-10-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213794 application number: ANDA213794

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	00872852-680a-41b3-901b-b991b12a176d	6
197805	ibuprofen 400 MG Oral Tablet	PSN	1991c503-ef6e-42dc-ada4-f909962dd789	6
197805	ibuprofen 400 MG Oral Tablet	PSN	408c977c-2cf7-4175-877d-d221ed49248a	6
197806	ibuprofen 600 MG Oral Tablet	PSN	00872852-680a-41b3-901b-b991b12a176d	6
197807	ibuprofen 800 MG Oral Tablet	PSN	00872852-680a-41b3-901b-b991b12a176d	6
197805	ibuprofen 400 MG Oral Tablet	SCD	00872852-680a-41b3-901b-b991b12a176d	6
197805	ibuprofen 400 MG Oral Tablet	SCD	1991c503-ef6e-42dc-ada4-f909962dd789	6
197805	ibuprofen 400 MG Oral Tablet	SCD	408c977c-2cf7-4175-877d-d221ed49248a	6
197806	ibuprofen 600 MG Oral Tablet	SCD	00872852-680a-41b3-901b-b991b12a176d	6
197807	ibuprofen 800 MG Oral Tablet	SCD	00872852-680a-41b3-901b-b991b12a176d	6
197805	ibuprofen 400 MG Oral Tablet	PSN	ec6b2df4-2f4f-4601-8b53-0542664e0bd9	4
197805	ibuprofen 400 MG Oral Tablet	PSN	bdc3f482-6fba-4420-9118-0f5cb7744e97	4
197805	ibuprofen 400 MG Oral Tablet	SCD	ec6b2df4-2f4f-4601-8b53-0542664e0bd9	4
197805	ibuprofen 400 MG Oral Tablet	SCD	bdc3f482-6fba-4420-9118-0f5cb7744e97	4
197805	ibuprofen 400 MG Oral Tablet	PSN	fe939219-d752-63a0-e053-6394a90a0ab2	3
197805	ibuprofen 400 MG Oral Tablet	SCD	fe939219-d752-63a0-e053-6394a90a0ab2	3
197805	ibuprofen 400 MG Oral Tablet	PSN	793e4b36-8208-4fa3-9f4f-9e9e72648280	2
197805	ibuprofen 400 MG Oral Tablet	PSN	f4235736-3053-1ee0-e053-2a95a90a421c	2
197805	ibuprofen 400 MG Oral Tablet	PSN	05ce8e8e-0b25-061e-e063-6394a90a2e92	2
197805	ibuprofen 400 MG Oral Tablet	PSN	1be33b4f-4987-580f-e063-6294a90a3103	2
197806	ibuprofen 600 MG Oral Tablet	PSN	793e4b36-8208-4fa3-9f4f-9e9e72648280	2
197807	ibuprofen 800 MG Oral Tablet	PSN	793e4b36-8208-4fa3-9f4f-9e9e72648280	2
197805	ibuprofen 400 MG Oral Tablet	SCD	793e4b36-8208-4fa3-9f4f-9e9e72648280	2
197805	ibuprofen 400 MG Oral Tablet	SCD	1be33b4f-4987-580f-e063-6294a90a3103	2
197805	ibuprofen 400 MG Oral Tablet	SCD	f4235736-3053-1ee0-e053-2a95a90a421c	2
197805	ibuprofen 400 MG Oral Tablet	SCD	05ce8e8e-0b25-061e-e063-6394a90a2e92	2
197806	ibuprofen 600 MG Oral Tablet	SCD	793e4b36-8208-4fa3-9f4f-9e9e72648280	2
197807	ibuprofen 800 MG Oral Tablet	SCD	793e4b36-8208-4fa3-9f4f-9e9e72648280	2
197805	ibuprofen 400 MG Oral Tablet	PSN	266d7b87-8b21-3db2-e063-6394a90a4de0	1
197805	ibuprofen 400 MG Oral Tablet	PSN	d50f829d-071f-4299-9b74-0f28caac7118	1
197805	ibuprofen 400 MG Oral Tablet	SCD	d50f829d-071f-4299-9b74-0f28caac7118	1
197805	ibuprofen 400 MG Oral Tablet	SCD	266d7b87-8b21-3db2-e063-6394a90a4de0	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59651-360-01	59651036001	100 TABLET in 1 BOTTLE (59651-360-01)	100 tablet	2020-05-08	0000-00-00	No	No	Current
59651-360-05	59651036005	500 TABLET in 1 BOTTLE (59651-360-05)	500 tablet	2020-05-08	0000-00-00	No	No	Current
59651-360-23	59651036023	2100 TABLET in 1 BAG (59651-360-23)	2100 tablet	08-MAY-20				Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ibuprofen Tablets, USP Rx only	HAWAII REPACK, INC.	2026-06-26	HUMAN PRESCRIPTION DRUG LABEL	1
Ibuprofen Tablets, USP Rx only	Sportpharm LLC	2026-06-26	HUMAN PRESCRIPTION DRUG LABEL	1
Ibuprofen Tablets, USP Rx only	REMEDYREPACK INC.	2026-06-10	HUMAN PRESCRIPTION DRUG LABEL	5
Ibuprofen Tablets, USP Rx only	Preferred Pharmaceuticals Inc.	2026-05-13	HUMAN PRESCRIPTION DRUG LABEL	4
Ibuprofen Tablets, USP Rx only	NuCare Pharmaceuticals,Inc.	2026-05-07	HUMAN PRESCRIPTION DRUG LABEL	2
Ibuprofen	Direct_rx	2025-10-13	HUMAN PRESCRIPTION DRUG LABEL	2
Ibuprofen Tablets, USP Rx only	Bryant Ranch Prepack	2025-09-17	HUMAN PRESCRIPTION DRUG LABEL	1
Ibuprofen Tablets, USP Rx only	Aurobindo Pharma Limited \| APL HEALTHCARE LIMITED	2025-02-14	Human Prescription Drug Label	6
Ibuprofen Tablets, USP Rx only	NuCare Pharmaceuticals,Inc.	2024-12-19	HUMAN PRESCRIPTION DRUG LABEL	3
Ibuprofen Tablets, USP Rx only	Coupler LLC	2024-11-08	HUMAN PRESCRIPTION DRUG LABEL	1
Ibuprofen Tablets, USP Rx only	Redpharm Drug, Inc.	2024-08-08	HUMAN PRESCRIPTION DRUG LABEL	2
Ibuprofen Tablets, USP Rx only	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2023-10-06	HUMAN PRESCRIPTION DRUG LABEL	2
Ibuprofen Tablets, USP Rx only	A-S Medication Solutions	2023-09-06	Human Prescription Drug Label	6
Ibuprofen Tablets, USP Rx only	A-S Medication Solutions	2023-09-06	Human Prescription Drug Label	6