Cefdinir

Product NDC: 67253-011
11-digit product format: 672530011
Labeler code: 67253
Product ID: 67253-011_b357e467-f169-418a-b3aa-9e3b8215969a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cefdinir
Dosage form: CAPSULE
Route: ORAL
Labeler: DAVA Pharmaceuticals Inc
Application: ANDA065330
Marketing category: ANDA
Marketing start: 2014-05-01
Marketing end: 2020-11-30
Substance: CEFDINIR
Active strength: 300 mg/1
Pharmacologic classes: Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	67253-011		D	Discontinued by firm		2026-08-03
excluded package	package	67253-011	67253-011-06	D	Discontinued by firm		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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67253-011-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67253-011-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67253-011-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67253-011-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67253-011-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67253-011-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67253-011-06	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67253-011-06	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67253-011-06	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67253-011-06	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	67253-011-06	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67253-011-06	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A065330-001	CEFDINIR	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065330-001	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065330-001	CEFDINIR	300MG	CAPSULE / ORAL	AB	RS	2007-04-06	`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	A065330-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065330-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065330-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065330-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065330-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065330-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065330-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065330-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065330-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065330-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065330-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065330-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065330-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065330-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065330-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065330-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065330-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065330-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065330-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065330-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065330-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065330-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065330-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065330-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065330-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065330-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065330-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065330-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065330-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065330-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065330-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065330-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065330-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065330-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065330-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065330-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065330-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065330-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065330-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065330-001	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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67253-011-06	EA - Each	67253-011	f6769ce9-7291-42d4-aff6-7ac7af0a1682	1	2014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CEFDINIR	ACTIVE INGREDIENT	CI0FAO63WC	CEFDINIR CAPSULE [DAVA PHARMACEUTICALS INC]	10
CEFDINIR	ACTIVE MOIETY	CI0FAO63WC	CEFDINIR CAPSULE [DAVA PHARMACEUTICALS INC]	10
CARBOXYMETHYLCELLULOSE CALCIUM	INACTIVE INGREDIENT	UTY7PDF93L	CEFDINIR CAPSULE [DAVA PHARMACEUTICALS INC]	10
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	CEFDINIR CAPSULE [DAVA PHARMACEUTICALS INC]	10
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CEFDINIR CAPSULE [DAVA PHARMACEUTICALS INC]	10
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CEFDINIR CAPSULE [DAVA PHARMACEUTICALS INC]	10
POLYOXYL 40 STEARATE	INACTIVE INGREDIENT	13A4J4NH9I	CEFDINIR CAPSULE [DAVA PHARMACEUTICALS INC]	10
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CEFDINIR CAPSULE [DAVA PHARMACEUTICALS INC]	10
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CEFDINIR CAPSULE [DAVA PHARMACEUTICALS INC]	10
CEFDINIR	ACTIVE INGREDIENT	CI0FAO63WC	CEFDINIR CAPSULE [NORTHWIND PHARMACEUTICALS, LLC]	1
CEFDINIR	ACTIVE MOIETY	CI0FAO63WC	CEFDINIR CAPSULE [NORTHWIND PHARMACEUTICALS, LLC]	1

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	Sandoz Inc	38f6adf7-e26c-4764-8ec9-360813874dd4	2020-02-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065330 application number: ANDA065330
Cefdinir	CEFDINIR	Proficient Rx LP	f30d01e3-0839-4928-a45a-b46c89aa454c	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065330 application number: ANDA065330

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	4f30e131-a11d-042a-e054-00144ff88e88	2
200346	cefdinir 300 MG Oral Capsule	SCD	4f30e131-a11d-042a-e054-00144ff88e88	2

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cefdinir - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2020-01-20	HUMAN PRESCRIPTION DRUG LABEL	2
CEFDINIR CAPSULES	A-S Medication Solutions	2017-12-01	HUMAN PRESCRIPTION DRUG LABEL	7
CEFDINIR	Northwind Pharmaceuticals, LLC	2015-03-25	HUMAN PRESCRIPTION DRUG LABEL	1
CEFDINIR CAPSULES	DAVA Pharmaceuticals Inc	2014-02-12	HUMAN PRESCRIPTION DRUG LABEL	13