Cefdinir

Product NDC: 68071-4856
Requested package NDC: 68071-4856-2
11-digit product format: 680714856
Labeler code: 68071
Product ID: 68071-4856_3cd49451-feee-089c-e063-6294a90a7103
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cefdinir
Dosage form: CAPSULE
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA065264
Marketing category: ANDA
Marketing start: 2007-05-01
Substance: CEFDINIR
Active strength: 300 mg/1
Pharmacologic classes: Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 13 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
2025-04-01 02:39 UTC · source 2025-03-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Cefdinir
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CEFDINIR	300 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
CI0FAO63WC	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
200346	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
86c21cdd-8b94-f4dc-e053-2991aa0a51eb	Available on FDA.report

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#

Effective, Related label table
Effective	Related label
2024-06-14	CEFDINIR CAPSULES USP
2023-01-30	CEFDINIR CAPSULES USP
2021-02-17	CEFDINIR CAPSULES USP
2021-01-29	CEFDINIR CAPSULES USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-4856-2	Cefdinir	20 in 1 BOTTLE	CAPSULE	20		5
68071-4856-7	Cefdinir	14 in 1 BOTTLE	CAPSULE	14		5

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 ndc (package): 68071-4856-2 ndc (product): 68071-4856 ndc11 (package): 68071485602
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	86c21cdd-8b94-f4dc-e053-2991aa0a51eb	5
200346	cefdinir 300 MG Oral Capsule	SCD	86c21cdd-8b94-f4dc-e053-2991aa0a51eb	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-4856-2	68071485602	20 CAPSULE in 1 BOTTLE (68071-4856-2)	20 capsule	2019-04-17	0000-00-00	No	No	Current