Cefadroxil

Product NDC: 52959-428
11-digit product format: 529590428
Labeler code: 52959
Product ID: 52959-428_142c98e2-4356-4f18-a596-90fddd02d067
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cefadroxil
Dosage form: CAPSULE
Route: ORAL
Labeler: H.J. Harkins Company, Inc.
Application: ANDA065392
Marketing category: ANDA
Marketing start: 2008-04-01
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
52959-428-04	2019-11-13	C162847	48780-1	97449f38-c0a7-f6ea-e053-dbdaa90aa703	Cefadroxil Capsules USP 500 mg
52959-428-10	2019-11-13	C162847	48780-1	97449f38-c0a7-f6ea-e053-dbdaa90aa703	Cefadroxil Capsules USP 500 mg
52959-428-14	2019-11-13	C162847	48780-1	97449f38-c0a7-f6ea-e053-dbdaa90aa703	Cefadroxil Capsules USP 500 mg
52959-428-15	2019-11-13	C162847	48780-1	97449f38-c0a7-f6ea-e053-dbdaa90aa703	Cefadroxil Capsules USP 500 mg
52959-428-16	2019-11-13	C162847	48780-1	97449f38-c0a7-f6ea-e053-dbdaa90aa703	Cefadroxil Capsules USP 500 mg
52959-428-18	2019-11-13	C162847	48780-1	97449f38-c0a7-f6ea-e053-dbdaa90aa703	Cefadroxil Capsules USP 500 mg
52959-428-20	2019-11-13	C162847	48780-1	97449f38-c0a7-f6ea-e053-dbdaa90aa703	Cefadroxil Capsules USP 500 mg
52959-428-28	2019-11-13	C162847	48780-1	97449f38-c0a7-f6ea-e053-dbdaa90aa703	Cefadroxil Capsules USP 500 mg
52959-428-30	2019-11-13	C162847	48780-1	97449f38-c0a7-f6ea-e053-dbdaa90aa703	Cefadroxil Capsules USP 500 mg

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
52959-428-04	Cefadroxil	4 in 1 BOTTLE	CAPSULE	4	2
52959-428-10	Cefadroxil	10 in 1 BOTTLE	CAPSULE	10	2
52959-428-14	Cefadroxil	14 in 1 BOTTLE	CAPSULE	14	2
52959-428-15	Cefadroxil	15 in 1 BOTTLE	CAPSULE	15	2
52959-428-16	Cefadroxil	16 in 1 BOTTLE	CAPSULE	16	2
52959-428-18	Cefadroxil	18 in 1 BOTTLE	CAPSULE	18	2
52959-428-20	Cefadroxil	20 in 1 BOTTLE	CAPSULE	20	2
52959-428-28	Cefadroxil	28 in 1 BOTTLE	CAPSULE	28	2
52959-428-30	Cefadroxil	30 in 1 BOTTLE	CAPSULE	30	2

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52959-428-04	EA - Each	52959-428	aa7568ba-e5f2-49b5-a2fb-fd14aff7710d	1	2012-07-24
52959-428-10	EA - Each	52959-428	14a74ba6-3190-47b0-838a-401ec10bdc31	1	2012-07-24
52959-428-14	EA - Each	52959-428	1772e4ce-29a9-4b29-94f1-ebce410acf81	1	2012-07-24
52959-428-15	EA - Each	52959-428	d4bb3e53-6373-42c1-a4c1-55fc1781249f	1	2012-07-24
52959-428-16	EA - Each	52959-428	0abe2691-a841-4e01-ba15-0eda39958046	1	2012-07-24
52959-428-18	EA - Each	52959-428	f86c8c34-df93-4cc2-b30a-40484894fac4	1	2012-07-24
52959-428-20	EA - Each	52959-428	ed857f30-af56-45f7-96e6-d8993997fe48	1	2012-07-24
52959-428-28	EA - Each	52959-428	305c65cc-dd55-4afe-b058-2e1769c5ace2	1	2012-07-24
52959-428-30	EA - Each	52959-428	4791d3a0-ee1c-4424-9b25-8e0a32eabdd9	1	2012-07-24

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

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52959-428	CEFADROXIL CAPSULE [H.J. HARKINS COMPANY, INC.]	2	Legacy NDC, 9 package rows	20120120_7d49a2f4-c2b9-4127-82df-092da20a35d0.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	7d49a2f4-c2b9-4127-82df-092da20a35d0	2
309049	cefadroxil 500 MG Oral Capsule	SCD	7d49a2f4-c2b9-4127-82df-092da20a35d0	2
309049	cefadroxil (as cefadroxil monohydrate) 500 MG Oral Capsule	SY	7d49a2f4-c2b9-4127-82df-092da20a35d0	2

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
52959-428-04	52959042804	4 in 1 BOTTLE	Historical
52959-428-10	52959042810	10 in 1 BOTTLE	Historical
52959-428-14	52959042814	14 in 1 BOTTLE	Historical
52959-428-15	52959042815	15 in 1 BOTTLE	Historical
52959-428-16	52959042816	16 in 1 BOTTLE	Historical
52959-428-18	52959042818	18 in 1 BOTTLE	Historical
52959-428-20	52959042820	20 in 1 BOTTLE	Historical
52959-428-28	52959042828	28 in 1 BOTTLE	Historical
52959-428-30	52959042830	30 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cefadroxil Capsules USP 500 mg	H.J. Harkins Company, Inc.	2012-01-19	HUMAN PRESCRIPTION DRUG LABEL	2