Cefadroxil

Product NDC: 57237-097
11-digit product format: 572370097
Labeler code: 57237
Product ID: 57237-097_59b4c983-458c-4363-b2e6-4253a2bc7992
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cefadroxil
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: Rising Pharma Holdings, Inc.
Application: ANDA065349
Marketing category: ANDA
Marketing start: 2013-04-25
Substance: CEFADROXIL
Active strength: 250 mg/5mL
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
CEFADROXIL	250 mg/5mL

Field, Values table
Field	Values
Unii	280111G160
Rxcui	105171, 309048

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
560bed03-0257-a1db-0638-2c46fc35054c	Product name	2	20170824
34f1b9ee-0673-df8c-ddae-36eaf4c48382	Product name	1	20140508
3793572a-4958-68b2-f923-8cf695ec1cc1	Product name	1	20140508

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57237-097-01	Cefadroxil	100 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	100		6
57237-097-50	Cefadroxil	50 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	50		6

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57237-097-01	ML - Milliliter	57237-097	431c9fd9-09bd-4a7d-8167-78fc1aee1cb2	1	2015-02-02

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CEFADROXIL	ACTIVE INGREDIENT	280111G160	CEFADROXIL POWDER, FOR SUSPENSION [CITRON PHARMA LLC]	1
CEFADROXIL ANHYDROUS	ACTIVE MOIETY	Q525PA8JJB	CEFADROXIL POWDER, FOR SUSPENSION [CITRON PHARMA LLC]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CEFADROXIL POWDER, FOR SUSPENSION [CITRON PHARMA LLC]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	CEFADROXIL POWDER, FOR SUSPENSION [CITRON PHARMA LLC]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	CEFADROXIL POWDER, FOR SUSPENSION [CITRON PHARMA LLC]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	CEFADROXIL POWDER, FOR SUSPENSION [CITRON PHARMA LLC]	1
SULFUR DIOXIDE	INACTIVE INGREDIENT	0UZA3422Q4	CEFADROXIL POWDER, FOR SUSPENSION [CITRON PHARMA LLC]	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	CEFADROXIL POWDER, FOR SUSPENSION [CITRON PHARMA LLC]	1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57237-097	CEFADROXIL POWDER, FOR SUSPENSION [RISING PHARMA HOLDINGS, INC.]	6	Current NDC, Legacy NDC, 2 package rows	20240215_6e4111d3-f11b-403c-b340-b216022709df.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
280111G160	CEFADROXIL	66592-87-8	CEFADROXIL

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
309048	cefadroxil 250 MG in 5 mL Oral Suspension	PSN	6e4111d3-f11b-403c-b340-b216022709df	6
105171	cefadroxil 500 MG in 5 mL Oral Suspension	PSN	6e4111d3-f11b-403c-b340-b216022709df	6
105171	cefadroxil 100 MG/ML Oral Suspension	SCD	6e4111d3-f11b-403c-b340-b216022709df	6
309048	cefadroxil 50 MG/ML Oral Suspension	SCD	6e4111d3-f11b-403c-b340-b216022709df	6
105171	cefadroxil (as cefadroxil monohydrate) 100 MG/ML Oral Suspension	SY	6e4111d3-f11b-403c-b340-b216022709df	6
309048	cefadroxil (as cefadroxil monohydrate) 50 MG/ML Oral Suspension	SY	6e4111d3-f11b-403c-b340-b216022709df	6
309048	cefadroxil 250 MG per 5 ML Powder for Oral Suspension	SY	6e4111d3-f11b-403c-b340-b216022709df	6
105171	cefadroxil 500 MG per 5 ML Powder for Oral Suspension	SY	6e4111d3-f11b-403c-b340-b216022709df	6

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57237-097-01	57237009701	100 mL in 1 BOTTLE (57237-097-01)	100 ml	2013-04-25	0000-00-00	No	No	Current
57237-097-50	57237009750	50 mL in 1 BOTTLE (57237-097-50)	50 ml	2013-04-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cefadroxil for Oral Suspension, USP Rx only	Rising Pharma Holdings, Inc. \| Aurobindo Pharma Limited	2024-02-09	Human Prescription Drug Label	6