Cefdinir

Product NDC: 67296-1448
11-digit product format: 672961448
Labeler code: 67296
Product ID: 67296-1448_2c623bbf-8af9-a70c-e063-6294a90a6d94
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cefdinir
Dosage form: CAPSULE
Route: ORAL
Labeler: Redpharm Drug, Inc.
Application: ANDA210220
Marketing category: ANDA
Marketing start: 2021-02-20
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

Additional Listing Data#

Ingredient, Strength table
Ingredient	Strength
CEFDINIR	300 mg/1

Field, Values table
Field	Values
Unii	CI0FAO63WC
Rxcui	200346

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

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67296-1448-7	2025-01-30	C162847	48780-1	2cef2736-8729-d83d-e063-dadaa90ab31f	CEFDINIR CAPSULES, USP 300 mg Rx only To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir and other antibacterial drugs, cefdinir should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67296-1448-1	Cefdinir	10 in 1 BOTTLE	CAPSULE	10	3
67296-1448-2	Cefdinir	20 in 1 BOTTLE	CAPSULE	20	3
67296-1448-7	Cefdinir	14 in 1 BOTTLE	CAPSULE	14	1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67296-1448	CEFDINIR CAPSULE [REDPHARM DRUG, INC.]	3	Current NDC, 2 package rows	20250124_f3d228c8-bde9-ffcf-e053-2a95a90aa5c4.zip
67296-1448	CEFDINIR CAPSULE [REDPHARM DRUG,]	1	Current NDC, 1 package rows	20230204_f3cdc850-d3bf-1b0e-e053-2a95a90a7a3b.zip

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

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
200346	cefdinir 300 MG Oral Capsule	PSN	f3d228c8-bde9-ffcf-e053-2a95a90aa5c4	3
200346	cefdinir 300 MG Oral Capsule	SCD	f3d228c8-bde9-ffcf-e053-2a95a90aa5c4	3
200346	cefdinir 300 MG Oral Capsule	PSN	f3cdc850-d3bf-1b0e-e053-2a95a90a7a3b	1
200346	cefdinir 300 MG Oral Capsule	SCD	f3cdc850-d3bf-1b0e-e053-2a95a90a7a3b	1

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
67296-1448-1	67296144801	10 CAPSULE in 1 BOTTLE (67296-1448-1)	10 capsule	2021-02-20	No	No	Current
67296-1448-2	67296144802	20 CAPSULE in 1 BOTTLE (67296-1448-2)	20 capsule	2021-02-20	No	No	Current
67296-1448-7	67296144807	14 in 1 BOTTLE					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cefdinir	Redpharm Drug, Inc.	2025-01-23	HUMAN PRESCRIPTION DRUG LABEL	3
Cefdinir	Redpharm Drug, \| Redpharm Drug, Inc.	2023-02-03	HUMAN PRESCRIPTION DRUG LABEL	1