Cefdinir

Product NDC: 67296-0868
Requested package NDC: 67296-0868-2
11-digit product format: 672960868
Labeler code: 67296
Product ID: 67296-0868_bd5caea8-56e8-7279-e053-2995a90aa1a1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cefdinir
Dosage form: CAPSULE
Route: ORAL
Labeler: EPM Packaging, Inc.
Application: ANDA065368
Marketing category: ANDA
Marketing start: 2007-05-09
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	67296-0868	67296-0868-2	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 · 4 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`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
A065368-001	CEFDINIR	CEFDINIR	300MG	CAPSULE / ORAL	AB		2007-05-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065368-001	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	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065368-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	2007-05-09	`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	A065368-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065368-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065368-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065368-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065368-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065368-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065368-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065368-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065368-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065368-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065368-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065368-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065368-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065368-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065368-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065368-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065368-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065368-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065368-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065368-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065368-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065368-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065368-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065368-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065368-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065368-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065368-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065368-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065368-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065368-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065368-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065368-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065368-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065368-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065368-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065368-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065368-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065368-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065368-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065368-001	AB	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
351abe41-466c-4dd8-840a-0fdb68318bd5	Product name	1	20230316
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
67296-0868-1	2024-07-11	Cefdinir 300mg capsules
67296-0868-2	2024-07-11	Cefdinir 300mg capsules
67296-0868-3	2024-07-11	Cefdinir 300mg capsules
67296-0868-4	2024-07-11	Cefdinir 300mg capsules
67296-0868-1	2023-01-30	Cefdinir 300mg capsules
67296-0868-2	2023-01-30	Cefdinir 300mg capsules
67296-0868-3	2023-01-30	Cefdinir 300mg capsules
67296-0868-4	2023-01-30	Cefdinir 300mg capsules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67296-0868-1	Cefdinir	20 in 1 BOTTLE	CAPSULE	20	2
67296-0868-2	Cefdinir	14 in 1 BOTTLE	CAPSULE	14	2
67296-0868-3	Cefdinir	28 in 1 BOTTLE	CAPSULE	28	2
67296-0868-4	Cefdinir	10 in 1 BOTTLE	CAPSULE	10	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67296-0868	CEFDINIR CAPSULE [REDPHARM DRUG]	2	Legacy NDC, 4 package rows	20240712_bd5caea8-56e7-7279-e053-2995a90aa1a1.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cefdinir	CEFDINIR	AvKARE	1acc5d17-10a4-e23d-e063-6394a90a52c3	2026-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065368 application number: ANDA065368
Cefdinir	CEFDINIR	Teva Pharmaceuticals USA, Inc.	de3441e3-7fd2-4d29-a8b7-0f9b66e35c9c	2018-08-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065368 application number: ANDA065368

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	bd5caea8-56e7-7279-e053-2995a90aa1a1	2
200346	cefdinir 300 MG Oral Capsule	SCD	bd5caea8-56e7-7279-e053-2995a90aa1a1	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67296-0868-2	67296086802	14 CAPSULE in 1 BOTTLE (67296-0868-2)	14 capsule	2021-03-01	0000-00-00	No	No	Current