Cephalexin

Product NDC: 66116-607
11-digit product format: 661160607
Labeler code: 66116
Product ID: 66116-607_ca2ed054-b1a5-4174-b107-a26d8c9b31b2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cephalexin
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: MedVantx, Inc.
Application: ANDA062703
Marketing category: ANDA
Marketing start: 1990-09-30
Marketing end: 0000-00-00
Substance: CEPHALEXIN
Active strength: 250 mg/5mL
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
dfa3f520-409c-432e-b6d3-9250d468c772	Product name	1	20250401
64bb7f1a-2c2e-4741-8301-dbfeda7239f6	Product name	1	20190628
398aa563-bb78-fe0f-46a8-757c40ef28bf	Product name	1	20140508

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
66116-607-20	2019-11-27	C162847	48780-1	9855e2a2-42ae-60a7-e053-dbdaa90a05bd	CEPHALEXIN CAPSULES USP, 250 mg and 500 mg / CEPHALEXIN FOR ORAL SUSPENSION USP, 125 mg/5 mL and 250 mg/5 mL / CEPHALEXIN TABLETS USP, 250 mg and 500 mg 3145 3147 4175 4177 2238 2240 Rx only

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66116-607-20	Cephalexin	200 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	200		1

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CEPHALEXIN	ACTIVE INGREDIENT	OBN7UDS42Y	CEPHALEXIN POWDER, FOR SUSPENSION [MEDVANTX, INC.]	1
CEPHALEXIN ANHYDROUS	ACTIVE MOIETY	5SFF1W6677	CEPHALEXIN POWDER, FOR SUSPENSION [MEDVANTX, INC.]	1
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	CEPHALEXIN POWDER, FOR SUSPENSION [MEDVANTX, INC.]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	CEPHALEXIN POWDER, FOR SUSPENSION [MEDVANTX, INC.]	1
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	CEPHALEXIN POWDER, FOR SUSPENSION [MEDVANTX, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CEPHALEXIN POWDER, FOR SUSPENSION [MEDVANTX, INC.]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	CEPHALEXIN POWDER, FOR SUSPENSION [MEDVANTX, INC.]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	CEPHALEXIN POWDER, FOR SUSPENSION [MEDVANTX, INC.]	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	CEPHALEXIN POWDER, FOR SUSPENSION [MEDVANTX, INC.]	1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66116-607	CEPHALEXIN POWDER, FOR SUSPENSION [MEDVANTX, INC.]	1	Legacy NDC, 1 package rows	20140201_ca2ed054-b1a5-4174-b107-a26d8c9b31b2.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
OBN7UDS42Y	CEPHALEXIN	23325-78-2	CEPHALEXIN

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
309113	cephalexin 250 MG in 5 mL Oral Suspension	PSN	ca2ed054-b1a5-4174-b107-a26d8c9b31b2	1
309113	cephalexin 50 MG/ML Oral Suspension	SCD	ca2ed054-b1a5-4174-b107-a26d8c9b31b2	1
309113	cefalexin 50 MG/ML Oral Suspension	SY	ca2ed054-b1a5-4174-b107-a26d8c9b31b2	1
309113	cephalexin 250 MG per 5 ML Oral Suspension	SY	ca2ed054-b1a5-4174-b107-a26d8c9b31b2	1

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
66116-607-20	66116060720	200 mL in 1 BOTTLE	200 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cephalexin	MedVantx, Inc. \| Teva Pharmaceuticals USA Inc \| Blenheim Pharmacal Inc.	2012-07-25	HUMAN PRESCRIPTION DRUG LABEL	1