Cefdinir

Product NDC: 68071-2683
Requested package NDC: 68071-2683-1
11-digit product format: 680712683
Labeler code: 68071
Product ID: 68071-2683_ddbdb94c-509f-d65b-e053-2a95a90afec7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cefdinir
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA210534
Marketing category: ANDA
Marketing start: 2021-02-20
Marketing end: 0000-00-00
Substance: CEFDINIR
Active strength: 250 mg/5mL
Pharmacologic classes: Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	68071-2683	68071-2683-1	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 · 9 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
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A210534-001	CEFDINIR	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB		2021-02-19
A210534-002	CEFDINIR	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB		2021-02-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A210534-001	AB
A210534-002	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 · 68 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	A210534-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210534-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210534-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210534-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210534-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210534-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210534-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210534-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210534-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210534-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210534-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210534-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210534-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210534-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210534-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210534-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210534-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210534-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210534-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210534-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210534-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210534-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210534-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210534-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210534-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210534-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210534-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210534-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210534-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210534-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210534-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210534-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210534-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210534-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210534-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210534-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210534-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210534-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210534-001	CEFDINIR	125MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210534-002	CEFDINIR	250MG/5ML	FOR SUSPENSION / ORAL	AB	2021-02-19	`87673890dc5c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 68 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	A210534-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210534-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210534-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210534-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210534-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210534-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210534-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210534-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210534-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210534-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210534-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210534-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210534-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210534-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210534-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210534-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210534-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210534-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210534-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210534-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210534-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210534-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210534-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210534-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210534-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210534-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210534-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210534-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210534-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210534-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210534-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210534-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210534-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210534-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210534-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210534-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210534-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210534-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210534-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210534-002	AB	1	`87673890dc5c…`

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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-2683-1	2025-01-30	C162847	48780-1	2cef2736-75c8-d83d-e063-dadaa90ab31f	Cefdinir for Oral Suspension USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-2683-1	Cefdinir	100 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	100		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2683	CEFDINIR POWDER, FOR SUSPENSION [NUCARE PHARMACEUTICALS,INC.]	1	Legacy NDC, 1 package rows	20220429_ddbdb94c-509e-d65b-e053-2a95a90afec7.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
cefdinir	CEFDINIR	Preferred Pharmaceuticals Inc.	2e384d98-642e-4841-9f62-fcea4c242f4e	2026-03-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210534 application number: ANDA210534
cefdinir	CEFDINIR	A-S Medication Solutions	2bd2101c-511d-45a9-b1d8-a45ed40c5b80	2026-03-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210534 application number: ANDA210534
CEFDINIR	CEFDINIR	DIRECT RX	982d0f53-20bc-1cb4-e053-2995a90ad33c	2025-01-22	Warnings	Exact identifier application applno (ANDA): 210534 application number: ANDA210534
cefdinir	CEFDINIR	A-S Medication Solutions	7bbcc4ac-c964-4c6b-88c0-11c0ba9933db	2023-11-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210534 application number: ANDA210534
cefdinir	CEFDINIR	Ascend Laboratories, LLC	efb5a975-75ec-46e1-ba84-f68d0b9bf36f	2022-06-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210534 application number: ANDA210534

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
476576	cefdinir 250 MG in 5 mL Oral Suspension	PSN	ddbdb94c-509e-d65b-e053-2a95a90afec7	1
476576	cefdinir 50 MG/ML Oral Suspension	SCD	ddbdb94c-509e-d65b-e053-2a95a90afec7	1
476576	cefdinir 250 MG per 5 ML Oral Suspension	SY	ddbdb94c-509e-d65b-e053-2a95a90afec7	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-2683-1	68071268301	100 mL in 1 BOTTLE (68071-2683-1)	100 ml	2022-04-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cefdinir for Oral Suspension USP Rx only	NuCare Pharmaceuticals,Inc.	2022-04-28	HUMAN PRESCRIPTION DRUG LABEL	1