Ibuprofen

Product NDC: 58624-7012
Requested package NDC: 58624-7012-0
11-digit product format: 586247012
Labeler code: 58624
Product ID: 58624-7012_f0d5c414-1dee-411c-e053-2995a90ab83e
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Shandong Xinhua Pharmaceutical Co., Ltd.
Application: ANDA207095
Marketing category: ANDA
Marketing start: 2022-04-05
Marketing end: 0000-00-00
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: 2023-12-31
Current FDA listing: Historical FDA.report record

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	58624-7012	58624-7012-0	I	Inactivated by FDA		2026-08-10

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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A207095-001	IBUPROFEN	IBUPROFEN	200MG	TABLET / ORAL			2017-05-05
A207095-002	IBUPROFEN	IBUPROFEN	200MG	TABLET / ORAL			2018-08-21

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 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207095-001	IBUPROFEN	200MG	TABLET / ORAL	2017-05-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207095-002	IBUPROFEN	200MG	TABLET / ORAL	2018-08-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207095-001	IBUPROFEN	200MG	TABLET / ORAL	2017-05-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207095-002	IBUPROFEN	200MG	TABLET / ORAL	2018-08-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207095-001	IBUPROFEN	200MG	TABLET / ORAL	2017-05-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207095-002	IBUPROFEN	200MG	TABLET / ORAL	2018-08-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207095-001	IBUPROFEN	200MG	TABLET / ORAL	2017-05-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207095-002	IBUPROFEN	200MG	TABLET / ORAL	2018-08-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207095-001	IBUPROFEN	200MG	TABLET / ORAL	2017-05-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207095-002	IBUPROFEN	200MG	TABLET / ORAL	2018-08-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207095-001	IBUPROFEN	200MG	TABLET / ORAL	2017-05-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207095-002	IBUPROFEN	200MG	TABLET / ORAL	2018-08-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207095-001	IBUPROFEN	200MG	TABLET / ORAL	2017-05-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207095-002	IBUPROFEN	200MG	TABLET / ORAL	2018-08-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207095-001	IBUPROFEN	200MG	TABLET / ORAL	2017-05-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207095-002	IBUPROFEN	200MG	TABLET / ORAL	2018-08-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207095-001	IBUPROFEN	200MG	TABLET / ORAL	2017-05-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207095-002	IBUPROFEN	200MG	TABLET / ORAL	2018-08-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207095-001	IBUPROFEN	200MG	TABLET / ORAL	2017-05-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207095-002	IBUPROFEN	200MG	TABLET / ORAL	2018-08-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207095-001	IBUPROFEN	200MG	TABLET / ORAL	2017-05-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207095-002	IBUPROFEN	200MG	TABLET / ORAL	2018-08-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207095-001	IBUPROFEN	200MG	TABLET / ORAL	2017-05-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207095-002	IBUPROFEN	200MG	TABLET / ORAL	2018-08-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207095-001	IBUPROFEN	200MG	TABLET / ORAL	2017-05-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207095-002	IBUPROFEN	200MG	TABLET / ORAL	2018-08-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207095-001	IBUPROFEN	200MG	TABLET / ORAL	2017-05-05	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207095-002	IBUPROFEN	200MG	TABLET / ORAL	2018-08-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207095-001	IBUPROFEN	200MG	TABLET / ORAL	2017-05-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207095-002	IBUPROFEN	200MG	TABLET / ORAL	2018-08-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207095-001	IBUPROFEN	200MG	TABLET / ORAL	2017-05-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207095-002	IBUPROFEN	200MG	TABLET / ORAL	2018-08-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207095-001	IBUPROFEN	200MG	TABLET / ORAL	2017-05-05	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207095-002	IBUPROFEN	200MG	TABLET / ORAL	2018-08-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207095-001	IBUPROFEN	200MG	TABLET / ORAL	2017-05-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207095-001	IBUPROFEN	200MG	TABLET / ORAL	2017-05-05	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207095-002	IBUPROFEN	200MG	TABLET / ORAL	2018-08-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207095-001	IBUPROFEN	200MG	TABLET / ORAL	2017-05-05	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207095-002	IBUPROFEN	200MG	TABLET / ORAL	2018-08-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207095-001	IBUPROFEN	200MG	TABLET / ORAL	2017-05-05	`87673890dc5c…`

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, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58624-7012-0	2025-01-30	C162847	48780-1	2cef2736-8e28-d83d-e063-dadaa90ab31f	Ibuprofen Tablets, USP 200 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58624-7012-0	Ibuprofen	1 in 1 CARTON	TABLET, FILM COATED	1		2
58624-7012-0	Ibuprofen	24 in 1 BOTTLE	TABLET, FILM COATED	24		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58624-7012	IBUPROFEN TABLET, FILM COATED [SHANDONG XINHUA PHARMACEUTICAL CO., LTD.]	2	Legacy NDC, 2 package rows	20230307_f0d5cd00-e92a-9100-e053-2995a90a6dac.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	Shield Pharmaceuticals Corp	216e5600-56b4-44b0-88b7-69adfb245802	2026-08-06	Warnings	Exact identifier application applno (ANDA): 207095 application number: ANDA207095
Ibuprofen	IBUPROFEN	Shield Pharmaceuticals Corp	1ca722bb-940e-4b3e-9561-d87e2feb1ff8	2026-07-24	Warnings	Exact identifier application applno (ANDA): 207095 application number: ANDA207095
Ibuprofen	IBUPROFEN	Shield Pharmaceuticals Corp	fc6c29b4-f1b3-4cfe-8c96-564d083be39c	2026-07-24	Warnings	Exact identifier application applno (ANDA): 207095 application number: ANDA207095
Ibuprofen	IBUPROFEN	PROSTAT FIRST AID	3bca27b4-3df6-b7d1-e063-6394a90ac6af	2025-08-07	Warnings	Exact identifier application applno (ANDA): 207095 application number: ANDA207095
Ibuprofen	IBUPROFEN	Trifecta Pharmaceuticals USA LLC	37299475-e2f3-de26-e063-6394a90ad62d	2025-06-09	Warnings	Exact identifier application applno (ANDA): 207095 application number: ANDA207095
Ibuprofen	IBUPROFEN	Allegiant Health	2ea039d6-f522-4103-a1f9-5b80a3b12a27	2025-04-14	Warnings	Exact identifier application applno (ANDA): 207095 application number: ANDA207095
Ibuprofen	IBUPROFEN	Trifecta Pharmaceuticals USA LLC	09972806-e064-238d-e063-6394a90a7434	2024-12-31	Warnings	Exact identifier application applno (ANDA): 207095 application number: ANDA207095
Ibuprofen 200mg	IBUPROFEN 200MG	Allegiant Health	265e2b47-d14a-45a8-adc0-7214e2057103	2024-09-30	Warnings	Exact identifier application applno (ANDA): 207095 application number: ANDA207095
Ibuprofen	IBUPROFEN	Trifecta Pharmaceuticals USA LLC	114b5e23-6cd7-41d8-e063-6294a90aa0f0	2024-06-12	Warnings	Exact identifier application applno (ANDA): 207095 application number: ANDA207095

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	f0d5cd00-e92a-9100-e053-2995a90a6dac	2
310965	ibuprofen 200 MG Oral Tablet	SCD	f0d5cd00-e92a-9100-e053-2995a90a6dac	2
310965	ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral Tablet	SY	f0d5cd00-e92a-9100-e053-2995a90a6dac	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58624-7012-0	58624701200	1 BOTTLE in 1 CARTON (58624-7012-0) > 24 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2022-04-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ibuprofen Tablets, USP 200 mg	Shandong Xinhua Pharmaceutical Co., Ltd.	2023-03-06	HUMAN OTC DRUG LABEL	2