Cefadroxil

Product NDC: 10544-135
11-digit product format: 105440135
Labeler code: 10544
Product ID: 10544-135_11e2a86f-0d12-4eda-8472-9b94efe2ef58
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cefadroxil
Dosage form: CAPSULE
Route: ORAL
Labeler: Blenheim Pharmacal, Inc.
Application: ANDA065392
Marketing category: ANDA
Marketing start: 2011-07-11
Marketing end: 0000-00-00
Substance: CEFADROXIL
Active strength: 500 mg/1
Pharmacologic classes: Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

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

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
10544-135-20	2020-01-31	C162847	48780-1	9d75b9d0-5365-f424-e053-dadaa90a57ce	Cefadroxil Capsules USP 500 mg

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10544-135-20	Cefadroxil	50 in 1 BOTTLE	CAPSULE	50		2

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10544-135-20	EA - Each	10544-135	2b820c13-11ab-49a3-bcdf-0752aaad783b	1	2015-11-12

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CEFADROXIL	ACTIVE INGREDIENT	280111G160	CEFADROXIL CAPSULE [BLENHEIM PHARMACAL, INC.]	2
CEFADROXIL ANHYDROUS	ACTIVE MOIETY	Q525PA8JJB	CEFADROXIL CAPSULE [BLENHEIM PHARMACAL, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CEFADROXIL CAPSULE [BLENHEIM PHARMACAL, INC.]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	CEFADROXIL CAPSULE [BLENHEIM PHARMACAL, INC.]	2
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	CEFADROXIL CAPSULE [BLENHEIM PHARMACAL, INC.]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CEFADROXIL CAPSULE [BLENHEIM PHARMACAL, INC.]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	CEFADROXIL CAPSULE [BLENHEIM PHARMACAL, INC.]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	CEFADROXIL CAPSULE [BLENHEIM PHARMACAL, INC.]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CEFADROXIL CAPSULE [BLENHEIM PHARMACAL, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CEFADROXIL CAPSULE [BLENHEIM PHARMACAL, INC.]	2
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	CEFADROXIL CAPSULE [BLENHEIM PHARMACAL, INC.]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CEFADROXIL CAPSULE [BLENHEIM PHARMACAL, INC.]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	CEFADROXIL CAPSULE [BLENHEIM PHARMACAL, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CEFADROXIL CAPSULE [BLENHEIM PHARMACAL, INC.]	2

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10544-135	CEFADROXIL CAPSULE [BLENHEIM PHARMACAL, INC.]	2	Legacy NDC, 1 package rows	20151111_615617a6-40b9-46e2-9a3d-169ea5a671de.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
309049	cefadroxil 500 MG Oral Capsule	PSN	615617a6-40b9-46e2-9a3d-169ea5a671de	2
309049	cefadroxil 500 MG Oral Capsule	SCD	615617a6-40b9-46e2-9a3d-169ea5a671de	2
309049	cefadroxil (as cefadroxil monohydrate) 500 MG Oral Capsule	SY	615617a6-40b9-46e2-9a3d-169ea5a671de	2

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
10544-135-20	10544013520	50 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cefadroxil Capsules USP 500 mg	Blenheim Pharmacal, Inc.	2015-11-10	HUMAN PRESCRIPTION DRUG LABEL	2