Application 050739

Type: NDA
Sponsor: ABBVIE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OMNICEF	CEFDINIR	CAPSULE;ORAL	300MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N050739-001	OMNICEF	CEFDINIR	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1997-12-04

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N050739-001	OMNICEF	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1997-12-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050739-001	OMNICEF	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1997-12-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050739-001	OMNICEF	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1997-12-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050739-001	OMNICEF	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1997-12-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050739-001	OMNICEF	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1997-12-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050739-001	OMNICEF	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1997-12-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050739-001	OMNICEF	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1997-12-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050739-001	OMNICEF	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1997-12-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050739-001	OMNICEF	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1997-12-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050739-001	OMNICEF	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1997-12-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050739-001	OMNICEF	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1997-12-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050739-001	OMNICEF	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1997-12-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050739-001	OMNICEF	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1997-12-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050739-001	OMNICEF	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1997-12-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050739-001	OMNICEF	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1997-12-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050739-001	OMNICEF	300MG	CAPSULE / ORAL	RLD	1997-12-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050739-001	OMNICEF	300MG	CAPSULE / ORAL	RLD	1997-12-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050739-001	OMNICEF	300MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	RLD	1997-12-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050739-001	OMNICEF	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1997-12-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050739-001	OMNICEF	300MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	RLD	1997-12-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050739-001	OMNICEF	300MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	RLD	1997-12-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050739-001	OMNICEF	300MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	RLD	1997-12-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050739-001	OMNICEF	300MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	RLD	1997-12-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050739-001	OMNICEF	300MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	RLD	1997-12-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050739-001	OMNICEF	300MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	RLD	1997-12-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050739-001	OMNICEF	300MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	RLD	1997-12-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050739-001	OMNICEF	300MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	RLD	1997-12-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050739-001	OMNICEF	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1997-12-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050739-001	OMNICEF	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1997-12-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050739-001	OMNICEF	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1997-12-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050739-001	OMNICEF	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1997-12-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050739-001	OMNICEF	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1997-12-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050739-001	OMNICEF	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1997-12-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050739-001	OMNICEF	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1997-12-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050739-001	OMNICEF	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1997-12-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050739-001	OMNICEF	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1997-12-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050739-001	OMNICEF	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1997-12-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050739-001	OMNICEF	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1997-12-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050739-001	OMNICEF	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1997-12-04	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050739-001	OMNICEF	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1997-12-04	`cb3db0bc1861…`

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 4 · 68 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cefdinir	CEFDINIR	Northwind Health Company, LLC	1d0d50ba-8c2b-855c-e063-6394a90a5c7d	2026-07-09	Warnings, Adverse reactions	Name fallback generic name: CEFDINIR
Cefdinir	CEFDINIR	Proficient Rx LP	63d2f931-6896-47e5-905e-4f812d6cb105	2026-06-01	Warnings, Adverse reactions	Name fallback generic name: CEFDINIR
Cefdinir	CEFDINIR	REMEDYREPACK INC.	a8029f7c-6353-46db-8c8c-c86a9485a14f	2026-05-15	Warnings, Adverse reactions	Name fallback generic name: CEFDINIR
Cefdinir	CEFDINIR	NuCare Pharmaceuticals, Inc.	5128dc70-f3cd-25c0-e063-6294a90aa52f	2026-05-06	Warnings, Adverse reactions	Name fallback generic name: CEFDINIR
Cefdinir	CEFDINIR	Preferred Pharmaceuticals Inc.	3714d558-cbaa-42e8-831b-ffbbc951ebf2	2026-04-21	Warnings	Name fallback generic name: CEFDINIR
Cefdinir	CEFDINIR	Preferred Pharmaceuticals Inc.	5b6c1b5d-a1d5-4e08-9077-2af3f38fea4e	2026-03-24	Warnings, Adverse reactions	Name fallback generic name: CEFDINIR
Cefdinir	CEFDINIR	Preferred Pharmaceuticals Inc.	c3892cd7-0e98-4ba3-a845-4aedf6c2a830	2026-03-24	Warnings, Adverse reactions	Name fallback generic name: CEFDINIR
Cefdinir	CEFDINIR	Preferred Pharmaceuticals Inc.	2da6eb80-63b0-4377-8d7b-865733ebbab1	2026-03-24	Warnings, Adverse reactions	Name fallback generic name: CEFDINIR
Cefdinir	CEFDINIR	Preferred Pharmaceuticals Inc.	0d1212c9-604f-4999-8f7d-e7cf300705ef	2026-03-24	Warnings, Adverse reactions	Name fallback generic name: CEFDINIR
cefdinir	CEFDINIR	Preferred Pharmaceuticals Inc.	2e384d98-642e-4841-9f62-fcea4c242f4e	2026-03-24	Warnings, Adverse reactions	Name fallback generic name: CEFDINIR
Cefdinir	CEFDINIR	Preferred Pharmaceuticals, Inc.	8787ea15-bf90-4178-9b0f-08b075f1aa3d	2026-03-24	Warnings	Name fallback generic name: CEFDINIR
Cefdinir	CEFDINIR	NuCare Pharmaceuticals,Inc.	c23af6af-a97b-b98d-e053-2995a90ae780	2026-03-13	Warnings, Adverse reactions	Name fallback generic name: CEFDINIR
cefdinir	CEFDINIR	A-S Medication Solutions	2bd2101c-511d-45a9-b1d8-a45ed40c5b80	2026-03-12	Warnings, Adverse reactions	Name fallback generic name: CEFDINIR
Cefdinir	CEFDINIR	PD-Rx Pharmaceuticals, Inc.	a5f028d5-ab33-491e-a385-56e79e165150	2026-02-24	Warnings, Adverse reactions	Name fallback generic name: CEFDINIR
Cefdinir	CEFDINIR	REMEDYREPACK INC.	eb354221-c476-41cb-ad87-52423f81d698	2026-01-28	Warnings, Adverse reactions	Name fallback generic name: CEFDINIR
Cefdinir	CEFDINIR	AvKARE	1acc5d17-10a4-e23d-e063-6394a90a52c3	2026-01-13	Warnings, Adverse reactions	Name fallback generic name: CEFDINIR
Cefdinir	CEFDINIR	A-S Medication Solutions	17b4e82f-4169-4ab9-bd4a-79781a71e160	2025-12-19	Warnings	Name fallback generic name: CEFDINIR
Cefdinir	CEFDINIR	NuCare Pharmaceuticals,Inc.	9ba5cb2d-6272-27de-e053-2995a90a58c8	2025-12-03	Warnings, Adverse reactions	Name fallback generic name: CEFDINIR
Cefdinir	CEFDINIR	Major Pharmaceuticals	a0934baf-4745-4546-a63a-d4a660a188b3	2025-10-23	Warnings, Adverse reactions	Name fallback generic name: CEFDINIR
Cefdinir	CEFDINIR	PD-Rx Pharmaceuticals, Inc.	e296387e-eb20-4451-a184-f91748a4e9c7	2025-10-17	Warnings, Adverse reactions	Name fallback generic name: CEFDINIR

Documents#

Document, Submission type, Date table
Document	Submission type	Date
30415	SUPPL	2015-11-20
18147	SUPPL	2015-11-19
39220	SUPPL	2009-01-02
8149	SUPPL	2008-12-19
8148	SUPPL	2007-09-25
39219	SUPPL	2007-09-19
30414	SUPPL	2007-07-05
18146	SUPPL	2007-06-27
42709	ORIG	2006-01-03
30413	SUPPL	2005-07-21
18145	SUPPL	2005-07-21
30412	SUPPL	2004-09-03
8147	SUPPL	2002-07-24
39218	SUPPL	1999-11-24
30411	SUPPL	1999-11-24