Ibuprofen

Product NDC: 58602-802
11-digit product format: 586020802
Labeler code: 58602
Product ID: 58602-802_5e6a6cce-b25c-4d6c-9d58-b4db175c6f8e
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen
Dosage form: TABLET
Route: ORAL
Labeler: Aurohealth LLC
Application: ANDA208865
Marketing category: ANDA
Marketing start: 2017-11-08
Substance: IBUPROFEN
Active strength: 200 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

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A208865-001	IBUPROFEN	IBUPROFEN	200MG	TABLET / ORAL			2017-11-08

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 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208865-001	IBUPROFEN	200MG	TABLET / ORAL	2017-11-08	`e64feba35796…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
IBUPROFEN	200 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
310965	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
cf6fbf3b-a0f3-4e08-a981-d183fa285758	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
58602-802-07	Ibuprofen	24 in 1 BOTTLE	TABLET	24	3
58602-802-07	Ibuprofen	1 in 1 CARTON	TABLET	1	3
58602-802-14	Ibuprofen	1 in 1 CARTON	TABLET	1	3
58602-802-14	Ibuprofen	50 in 1 BOTTLE	TABLET	50	3
58602-802-21	Ibuprofen	1 in 1 CARTON	TABLET	1	3
58602-802-21	Ibuprofen	100 in 1 BOTTLE	TABLET	100	3
58602-802-29	Ibuprofen	1 in 1 CARTON	TABLET	1	3
58602-802-29	Ibuprofen	150 in 1 BOTTLE	TABLET	150	3
58602-802-34	Ibuprofen	200 in 1 BOTTLE	TABLET	200	3
58602-802-38	Ibuprofen	300 in 1 BOTTLE	TABLET	300	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58602-802	IBUPROFEN TABLET [AUROHEALTH LLC]	3	Current NDC, Legacy NDC, 10 package rows	20220310_cf6fbf3b-a0f3-4e08-a981-d183fa285758.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 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AMAZON BASIC CARE IBUPROFEN	IBUPROFEN	Amazon.com Services LLC	113dd693-6abe-1a0f-e063-6394a90a167e	2025-06-06	Warnings	Exact identifier application applno (ANDA): 208865 application number: ANDA208865
Ibuprofen	IBUPROFEN	Aurohealth LLC	09bd3935-526d-4ad1-898a-4f0d9499ebb9	2024-12-26	Warnings	Exact identifier application applno (ANDA): 208865 application number: ANDA208865
Ibuprofen	IBUPROFEN	Aurohealth LLC	1100648c-6b9f-49c9-94d0-c40f24fe5c27	2022-03-23	Warnings	Exact identifier application applno (ANDA): 208865 application number: ANDA208865
Ibuprofen	IBUPROFEN	Aurohealth LLC	0ade8ee2-7c74-4b05-925e-d92742fc2b90	2022-03-03	Warnings	Exact identifier application applno (ANDA): 208865 application number: ANDA208865
Ibuprofen	IBUPROFEN	Aurohealth LLC	cf6fbf3b-a0f3-4e08-a981-d183fa285758	2022-03-03	Warnings	Exact identifier application applno (ANDA): 208865 application number: ANDA208865 ndc (product): 58602-802

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
310965	ibuprofen 200 MG Oral Tablet	PSN	cf6fbf3b-a0f3-4e08-a981-d183fa285758	3
310965	ibuprofen 200 MG Oral Tablet	SCD	cf6fbf3b-a0f3-4e08-a981-d183fa285758	3
310965	ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral Tablet	SY	cf6fbf3b-a0f3-4e08-a981-d183fa285758	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58602-802-07	58602080207	1 BOTTLE in 1 CARTON (58602-802-07) / 24 TABLET in 1 BOTTLE	1 bottle	2017-11-08	0000-00-00	No	No	Current
58602-802-14	58602080214	1 BOTTLE in 1 CARTON (58602-802-14) / 50 TABLET in 1 BOTTLE	1 bottle	2017-11-08	0000-00-00	No	No	Current
58602-802-21	58602080221	1 BOTTLE in 1 CARTON (58602-802-21) / 100 TABLET in 1 BOTTLE	1 bottle	2017-11-08	0000-00-00	No	No	Current
58602-802-29	58602080229	1 BOTTLE in 1 CARTON (58602-802-29) / 150 TABLET in 1 BOTTLE	1 bottle	2017-11-08	0000-00-00	No	No	Current
58602-802-34	58602080234	200 TABLET in 1 BOTTLE (58602-802-34)	200 tablet	2017-11-08	0000-00-00	No	No	Current
58602-802-38	58602080238	300 TABLET in 1 BOTTLE (58602-802-38)	300 tablet	2017-11-08	0000-00-00	No	No	Current