Cefdinir

Product NDC: 67296-0469
Requested package NDC: 67296-0469-3
11-digit product format: 672960469
Labeler code: 67296
Product ID: 67296-0469_b8d03810-88c1-d272-e053-2a95a90aa617
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cefdinir
Dosage form: CAPSULE
Route: ORAL
Labeler: RedPharm Drug, Inc.
Application: ANDA065264
Marketing category: ANDA
Marketing start: 2007-05-01
Marketing end: 0000-00-00
Substance: CEFDINIR
Active strength: 300 mg/1
Pharmacologic classes: Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag: No
Listing certified through: 2022-12-31
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	67296-0469	67296-0469-3	I	Inactivated by FDA		2026-08-03

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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	67296-0469	67296-0469-3	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	67296-0469	67296-0469-3	I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67296-0469	67296-0469-3	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`

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
A065264-001	CEFDINIR	CEFDINIR	300MG	CAPSULE / ORAL	AB		2006-05-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065264-001	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 2 · 41 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	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065264-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2006-05-19	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A065264-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065264-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065264-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065264-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065264-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065264-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065264-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065264-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065264-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065264-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065264-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065264-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065264-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065264-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065264-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065264-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065264-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065264-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065264-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065264-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065264-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065264-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065264-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065264-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065264-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065264-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065264-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065264-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065264-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065264-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065264-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065264-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065264-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065264-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065264-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065264-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065264-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065264-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065264-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065264-001	AB	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d3e72f63-2c41-955f-f4ce-e90c6403e67c	Product name	2	20210729
e8e66e64-d220-99cb-44eb-0f32dc8cbda1	Product name	2	20210729

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
67296-0469-1	2026-01-29	Cednifir 300mg
67296-0469-2	2026-01-29	Cednifir 300mg
67296-0469-3	2026-01-29	Cednifir 300mg
67296-0469-1	2024-07-03	Cednifir 300mg
67296-0469-2	2024-07-03	Cednifir 300mg
67296-0469-3	2024-07-03	Cednifir 300mg
67296-0469-1	2023-01-30	Cednifir 300mg
67296-0469-2	2023-01-30	Cednifir 300mg
67296-0469-3	2023-01-30	Cednifir 300mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67296-0469-1	Cefdinir	20 in 1 BOTTLE	CAPSULE	20	11
67296-0469-2	Cefdinir	14 in 1 BOTTLE	CAPSULE	14	11
67296-0469-3	Cefdinir	10 in 1 BOTTLE	CAPSULE	10	11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CEFDINIR	ACTIVE INGREDIENT	CI0FAO63WC	CEFDINIR CAPSULE [REDPHARM DRUG INC.]	2
CEFDINIR	ACTIVE MOIETY	CI0FAO63WC	CEFDINIR CAPSULE [REDPHARM DRUG INC.]	2
CARBOXYMETHYLCELLULOSE CALCIUM	INACTIVE INGREDIENT	UTY7PDF93L	CEFDINIR CAPSULE [REDPHARM DRUG INC.]	2
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CEFDINIR CAPSULE [REDPHARM DRUG INC.]	2
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	CEFDINIR CAPSULE [REDPHARM DRUG INC.]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CEFDINIR CAPSULE [REDPHARM DRUG INC.]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	CEFDINIR CAPSULE [REDPHARM DRUG INC.]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CEFDINIR CAPSULE [REDPHARM DRUG INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CEFDINIR CAPSULE [REDPHARM DRUG INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CEFDINIR CAPSULE [REDPHARM DRUG INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67296-0469	CEFDINIR CAPSULE [REDPHARM DRUG, INC.]	11	Legacy NDC, 3 package rows	20240704_bcf04f49-8d0b-4563-9d0f-93939cdf6a6c.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cefdinir	CEFDINIR	Preferred Pharmaceuticals, Inc.	8787ea15-bf90-4178-9b0f-08b075f1aa3d	2026-03-24	Warnings	Exact identifier application applno (ANDA): 065264 application number: ANDA065264
Cefdinir	CEFDINIR	Lupin Pharmaceuticals, Inc.	cb7366ce-1778-451f-aba5-65cf73c9b87a	2025-10-14	Warnings	Exact identifier application applno (ANDA): 065264 application number: ANDA065264
Cefdinir	CEFDINIR	NuCare Pharmaceuticals,Inc.	86c21cdd-8b94-f4dc-e053-2991aa0a51eb	2025-08-20	Warnings	Exact identifier application applno (ANDA): 065264 application number: ANDA065264
Cefdinir	CEFDINIR	A-S Medication Solutions	12e89d69-7ef8-4dd6-ab64-a7fc3f1f8e70	2025-04-01	Warnings	Exact identifier application applno (ANDA): 065264 application number: ANDA065264

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
CI0FAO63WC	CEFDINIR	91832-40-5	CEFDINIR

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
200346	cefdinir 300 MG Oral Capsule	PSN	bcf04f49-8d0b-4563-9d0f-93939cdf6a6c	11
200346	cefdinir 300 MG Oral Capsule	SCD	bcf04f49-8d0b-4563-9d0f-93939cdf6a6c	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67296-0469-3	67296046903	10 CAPSULE in 1 BOTTLE (67296-0469-3)	10 capsule	2019-01-01	0000-00-00	No	No	Current