Cefadroxil

Product NDC: 65862-084
11-digit product format: 658620084
Labeler code: 65862
Product ID: 65862-084_74923cbc-7511-447d-b6b2-b2d0e805a0f5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cefadroxil
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA065349
Marketing category: ANDA
Marketing start: 2013-04-25
Substance: CEFADROXIL
Active strength: 500 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	500 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	SPL version
65862-084-01	Cefadroxil	100 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	100	8
65862-084-50	Cefadroxil	50 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	50	8
65862-084-75	Cefadroxil	75 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	75	8

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65862-084-01	ML - Milliliter	65862-084	e62041cc-dde3-4a50-87f3-9cddbc0715dd	1	2014-01-04
65862-084-75	ML - Milliliter	65862-084	2548a1a2-cb39-42b0-aae4-cf52302c7088	1	2014-01-04

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CEFADROXIL	ACTIVE INGREDIENT	280111G160	CEFADROXIL POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]	2
CEFADROXIL ANHYDROUS	ACTIVE MOIETY	Q525PA8JJB	CEFADROXIL POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CEFADROXIL POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	CEFADROXIL POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	CEFADROXIL POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	CEFADROXIL POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]	2
SULFUR DIOXIDE	INACTIVE INGREDIENT	0UZA3422Q4	CEFADROXIL POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]	2
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	CEFADROXIL POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]	2

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-084	CEFADROXIL POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]	8	Current NDC, Legacy NDC, 3 package rows	20240213_776a8dbc-e68e-4732-acf4-0133dca0f54c.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	776a8dbc-e68e-4732-acf4-0133dca0f54c	8
105171	cefadroxil 500 MG in 5 mL Oral Suspension	PSN	776a8dbc-e68e-4732-acf4-0133dca0f54c	8
105171	cefadroxil 100 MG/ML Oral Suspension	SCD	776a8dbc-e68e-4732-acf4-0133dca0f54c	8
309048	cefadroxil 50 MG/ML Oral Suspension	SCD	776a8dbc-e68e-4732-acf4-0133dca0f54c	8
105171	cefadroxil (as cefadroxil monohydrate) 100 MG/ML Oral Suspension	SY	776a8dbc-e68e-4732-acf4-0133dca0f54c	8
309048	cefadroxil (as cefadroxil monohydrate) 50 MG/ML Oral Suspension	SY	776a8dbc-e68e-4732-acf4-0133dca0f54c	8
309048	cefadroxil 250 MG per 5 ML Powder for Oral Suspension	SY	776a8dbc-e68e-4732-acf4-0133dca0f54c	8
105171	cefadroxil 500 MG per 5 ML Powder for Oral Suspension	SY	776a8dbc-e68e-4732-acf4-0133dca0f54c	8

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65862-084-01	65862008401	100 mL in 1 BOTTLE (65862-084-01)	100 ml	2013-04-25	0000-00-00	No	No	Current
65862-084-50	65862008450	50 mL in 1 BOTTLE (65862-084-50)	50 ml	2013-04-25	0000-00-00	No	No	Current
65862-084-75	65862008475	75 mL in 1 BOTTLE (65862-084-75)	75 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	Aurobindo Pharma Limited	2024-02-09	Human Prescription Drug Label	8