Cefdinir

Product NDC: 65862-177
11-digit product format: 658620177
Labeler code: 65862
Product ID: 65862-177_26399fd5-bcb0-4ab6-954a-ab3d5f20f2b3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cefdinir
Dosage form: CAPSULE
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA065434
Marketing category: ANDA
Marketing start: 2008-01-07
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#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CEFDINIR	300 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	CI0FAO63WC
Rxcui	200346

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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65862-177-05	Cefdinir	500 in 1 BOTTLE	CAPSULE	500	17
65862-177-30	Cefdinir	30 in 1 BOTTLE	CAPSULE	30	17
65862-177-60	Cefdinir	60 in 1 BOTTLE	CAPSULE	60	17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65862-177-60	EA - Each	65862-177	a8ab38cc-9c67-4880-94a0-f59e18d844dc	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CEFDINIR	ACTIVE INGREDIENT	CI0FAO63WC	CEFDINIR CAPSULE [AUROBINDO PHARMA LIMITED]	9
CEFDINIR	ACTIVE MOIETY	CI0FAO63WC	CEFDINIR CAPSULE [AUROBINDO PHARMA LIMITED]	9
CARBOXYMETHYLCELLULOSE CALCIUM	INACTIVE INGREDIENT	UTY7PDF93L	CEFDINIR CAPSULE [AUROBINDO PHARMA LIMITED]	9
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	CEFDINIR CAPSULE [AUROBINDO PHARMA LIMITED]	9
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CEFDINIR CAPSULE [AUROBINDO PHARMA LIMITED]	9
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	CEFDINIR CAPSULE [AUROBINDO PHARMA LIMITED]	9
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CEFDINIR CAPSULE [AUROBINDO PHARMA LIMITED]	9
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CEFDINIR CAPSULE [AUROBINDO PHARMA LIMITED]	9
SHELLAC	INACTIVE INGREDIENT	46N107B71O	CEFDINIR CAPSULE [AUROBINDO PHARMA LIMITED]	9
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CEFDINIR CAPSULE [AUROBINDO PHARMA LIMITED]	9
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CEFDINIR CAPSULE [AUROBINDO PHARMA LIMITED]	9
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CEFDINIR CAPSULE [AUROBINDO PHARMA LIMITED]	9
CEFDINIR	ACTIVE INGREDIENT	CI0FAO63WC	CEFDINIR CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
CEFDINIR	ACTIVE MOIETY	CI0FAO63WC	CEFDINIR CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
CARBOXYMETHYLCELLULOSE CALCIUM	INACTIVE INGREDIENT	UTY7PDF93L	CEFDINIR CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	CEFDINIR CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CEFDINIR CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	CEFDINIR CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CEFDINIR CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CEFDINIR CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
SHELLAC	INACTIVE INGREDIENT	46N107B71O	CEFDINIR CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CEFDINIR CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CEFDINIR CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CEFDINIR CAPSULE [PHYSICIANS TOTAL CARE, INC.]	3
CEFDINIR	ACTIVE INGREDIENT	CI0FAO63WC	CEFDINIR CAPSULE [REBEL DISTRIBUTORS CORP]	1
CEFDINIR	ACTIVE INGREDIENT	CI0FAO63WC	CEFDINIR CAPSULE [BLENHEIM PHARMACAL, INC.]	1
CEFDINIR	ACTIVE INGREDIENT	CI0FAO63WC	CEFDINIR (CEFDINIR) CAPSULE [H.J. HARKINS COMPANY, INC.]	1
CEFDINIR	ACTIVE MOIETY	CI0FAO63WC	CEFDINIR (CEFDINIR) CAPSULE [H.J. HARKINS COMPANY, INC.]	1
CEFDINIR	ACTIVE MOIETY	CI0FAO63WC	CEFDINIR CAPSULE [REBEL DISTRIBUTORS CORP]	1
CEFDINIR	ACTIVE MOIETY	CI0FAO63WC	CEFDINIR CAPSULE [BLENHEIM PHARMACAL, INC.]	1
CARBOXYMETHYLCELLULOSE CALCIUM	INACTIVE INGREDIENT	UTY7PDF93L	CEFDINIR CAPSULE [BLENHEIM PHARMACAL, INC.]	1
CARBOXYMETHYLCELLULOSE CALCIUM	INACTIVE INGREDIENT	UTY7PDF93L	CEFDINIR (CEFDINIR) CAPSULE [H.J. HARKINS COMPANY, INC.]	1
CARBOXYMETHYLCELLULOSE CALCIUM	INACTIVE INGREDIENT	UTY7PDF93L	CEFDINIR CAPSULE [REBEL DISTRIBUTORS CORP]	1
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	CEFDINIR CAPSULE [REBEL DISTRIBUTORS CORP]	1
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	CEFDINIR (CEFDINIR) CAPSULE [H.J. HARKINS COMPANY, INC.]	1
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	CEFDINIR CAPSULE [BLENHEIM PHARMACAL, INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CEFDINIR CAPSULE [REBEL DISTRIBUTORS CORP]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CEFDINIR CAPSULE [BLENHEIM PHARMACAL, INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CEFDINIR (CEFDINIR) CAPSULE [H.J. HARKINS COMPANY, INC.]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	CEFDINIR (CEFDINIR) CAPSULE [H.J. HARKINS COMPANY, INC.]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	CEFDINIR CAPSULE [BLENHEIM PHARMACAL, INC.]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	CEFDINIR CAPSULE [REBEL DISTRIBUTORS CORP]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CEFDINIR CAPSULE [BLENHEIM PHARMACAL, INC.]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CEFDINIR CAPSULE [REBEL DISTRIBUTORS CORP]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CEFDINIR (CEFDINIR) CAPSULE [H.J. HARKINS COMPANY, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CEFDINIR CAPSULE [BLENHEIM PHARMACAL, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CEFDINIR CAPSULE [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CEFDINIR (CEFDINIR) CAPSULE [H.J. HARKINS COMPANY, INC.]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	CEFDINIR CAPSULE [REBEL DISTRIBUTORS CORP]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	CEFDINIR (CEFDINIR) CAPSULE [H.J. HARKINS COMPANY, INC.]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	CEFDINIR CAPSULE [BLENHEIM PHARMACAL, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CEFDINIR CAPSULE [REBEL DISTRIBUTORS CORP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CEFDINIR CAPSULE [BLENHEIM PHARMACAL, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CEFDINIR (CEFDINIR) CAPSULE [H.J. HARKINS COMPANY, INC.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CEFDINIR CAPSULE [REBEL DISTRIBUTORS CORP]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CEFDINIR CAPSULE [BLENHEIM PHARMACAL, INC.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CEFDINIR (CEFDINIR) CAPSULE [H.J. HARKINS COMPANY, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CEFDINIR CAPSULE [REBEL DISTRIBUTORS CORP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CEFDINIR CAPSULE [BLENHEIM PHARMACAL, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CEFDINIR (CEFDINIR) CAPSULE [H.J. HARKINS COMPANY, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-177	CEFDINIR CAPSULE [AUROBINDO PHARMA LIMITED]	17	Current NDC, Legacy NDC, 3 package rows	20240213_df26edb0-9bd6-449c-a187-0be0c9e2600c.zip

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	f4f62b64-5350-4b4e-b8f2-381f54a0cd10	24
200346	cefdinir 300 MG Oral Capsule	PSN	e296387e-eb20-4451-a184-f91748a4e9c7	24
200346	cefdinir 300 MG Oral Capsule	SCD	f4f62b64-5350-4b4e-b8f2-381f54a0cd10	24
200346	cefdinir 300 MG Oral Capsule	SCD	e296387e-eb20-4451-a184-f91748a4e9c7	24
200346	cefdinir 300 MG Oral Capsule	PSN	a5f028d5-ab33-491e-a385-56e79e165150	18
200346	cefdinir 300 MG Oral Capsule	SCD	a5f028d5-ab33-491e-a385-56e79e165150	18
200346	cefdinir 300 MG Oral Capsule	PSN	df26edb0-9bd6-449c-a187-0be0c9e2600c	17
200346	cefdinir 300 MG Oral Capsule	SCD	df26edb0-9bd6-449c-a187-0be0c9e2600c	17
200346	cefdinir 300 MG Oral Capsule	PSN	9a90c686-fea0-47bb-bd71-e200b0e19c35	10
200346	cefdinir 300 MG Oral Capsule	SCD	9a90c686-fea0-47bb-bd71-e200b0e19c35	10
200346	cefdinir 300 MG Oral Capsule	PSN	9ba5cb2d-6272-27de-e053-2995a90a58c8	5
200346	cefdinir 300 MG Oral Capsule	SCD	9ba5cb2d-6272-27de-e053-2995a90a58c8	5
200346	cefdinir 300 MG Oral Capsule	PSN	2da6eb80-63b0-4377-8d7b-865733ebbab1	4
200346	cefdinir 300 MG Oral Capsule	SCD	2da6eb80-63b0-4377-8d7b-865733ebbab1	4
200346	cefdinir 300 MG Oral Capsule	PSN	f431ad55-24c8-e12a-e053-2a95a90aa043	3
200346	cefdinir 300 MG Oral Capsule	PSN	1a8e02a1-ecd0-41c5-8917-164991d9ceca	3
200346	cefdinir 300 MG Oral Capsule	PSN	a78a68a4-5425-43c4-81cc-7733b72445b8	3
200346	cefdinir 300 MG Oral Capsule	SCD	f431ad55-24c8-e12a-e053-2a95a90aa043	3
200346	cefdinir 300 MG Oral Capsule	SCD	1a8e02a1-ecd0-41c5-8917-164991d9ceca	3
200346	cefdinir 300 MG Oral Capsule	SCD	a78a68a4-5425-43c4-81cc-7733b72445b8	3
200346	cefdinir 300 MG Oral Capsule	PSN	a3262279-1f9e-401b-9b02-6da3ef374b46	1
200346	cefdinir 300 MG Oral Capsule	PSN	a84712bf-221d-4366-9cf0-b8c19428c276	1
200346	cefdinir 300 MG Oral Capsule	PSN	1181a59e-a433-20d0-e054-00144ff88e88	1
200346	cefdinir 300 MG Oral Capsule	PSN	5128dc70-f3cd-25c0-e063-6294a90aa52f	1
200346	cefdinir 300 MG Oral Capsule	PSN	1c422c29-9200-2d09-e063-6394a90aeb1a	1
200346	cefdinir 300 MG Oral Capsule	SCD	a84712bf-221d-4366-9cf0-b8c19428c276	1
200346	cefdinir 300 MG Oral Capsule	SCD	a3262279-1f9e-401b-9b02-6da3ef374b46	1
200346	cefdinir 300 MG Oral Capsule	SCD	5128dc70-f3cd-25c0-e063-6294a90aa52f	1
200346	cefdinir 300 MG Oral Capsule	SCD	1c422c29-9200-2d09-e063-6394a90aeb1a	1
200346	cefdinir 300 MG Oral Capsule	SCD	1181a59e-a433-20d0-e054-00144ff88e88	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65862-177-05	65862017705	500 CAPSULE in 1 BOTTLE (65862-177-05)	500 capsule	2008-01-07	0000-00-00	No	No	Current
65862-177-30	65862017730	30 CAPSULE in 1 BOTTLE (65862-177-30)	30 capsule	2008-01-07	0000-00-00	No	No	Current
65862-177-60	65862017760	60 CAPSULE in 1 BOTTLE (65862-177-60)	60 capsule	2008-01-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cefdinir Capsules, USP Rx only	NuCare Pharmaceuticals, Inc.	2026-05-06	HUMAN PRESCRIPTION DRUG LABEL	1
Cefdinir Capsules, USP Rx only	Preferred Pharmaceuticals Inc.	2026-03-24	HUMAN PRESCRIPTION DRUG LABEL	4
Cefdinir Capsules, USP Rx only	PD-Rx Pharmaceuticals, Inc.	2026-02-24	HUMAN PRESCRIPTION DRUG LABEL	18
Cefdinir Capsules, USP Rx only	NuCare Pharmaceuticals,Inc.	2025-12-03	HUMAN PRESCRIPTION DRUG LABEL	5
Cefdinir Capsules, USP Rx only	PD-Rx Pharmaceuticals, Inc.	2025-10-17	HUMAN PRESCRIPTION DRUG LABEL	24
Cefdinir Capsules, USP Rx only	PD-Rx Pharmaceuticals, Inc.	2025-10-17	HUMAN PRESCRIPTION DRUG LABEL	24
Cefdinir	Direct_Rx	2025-01-22	HUMAN PRESCRIPTION DRUG LABEL	3
Cefdinir Capsules, USP Rx only	Redpharm Drug	2024-07-02	HUMAN PRESCRIPTION DRUG LABEL	1
Cefdinir Capsules, USP Rx only	Aurobindo Pharma Limited	2024-02-12	Human Prescription Drug Label	17
Cefdinir Capsules, USP Rx only	A-S Medication Solutions	2021-02-22	Human Prescription Drug Label	10
Cefdinir Capsules, USP Rx only	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2021-01-04	HUMAN PRESCRIPTION DRUG LABEL	3
Cefdinir Capsules, USP Rx Only	Blenheim Pharmacal, Inc.	2015-03-17	HUMAN PRESCRIPTION DRUG LABEL	1
Cefdinir Capsules	H.J. Harkins Company, Inc. \| Aurobindo Pharma Limited	2011-08-23	Human Prescription Drug Label	1
Cefdinir Capsules	Rebel Distributors Corp	2011-01-17	HUMAN PRESCRIPTION DRUG LABEL	1
Cefdinir Capsules	Physicians Total Care, Inc.	2010-12-02	Human Prescription Drug Label	3

Cefdinir

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#