NDC Code(s) : 50436-0219-2
Packager : Unit Dose Services

Category : Human Prescription Drug Label

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Cephalexin Cephalexin CAPSULE
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:50436-0219(NDC:67877-219)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEPHALEXIN(UNII: OBN7UDS42Y)
(CEPHALEXIN ANHYDROUS - UNII:5SFF1W6677) 		CEPHALEXIN ANHYDROUS500 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
MAGNESIUM STEARATE(UNII: 70097M6I30)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SHELLAC(UNII: 46N107B71O)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
AMMONIA(UNII: 5138Q19F1X)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
Product Characteristics
Color GREEN (light green cap and body) Score no score
Shape CAPSULE Size 22 mm
Flavor Imprint Code 219
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50436-0219-220 in 1 BOTTLE Type 0: Not a Combination Product27/09/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090836 01/19/2011

LABELER - Unit Dose Services(831995316)

Establishment
Name Address ID/FEI Business Operations
Unit Dose Services 831995316 REPACK(50436-0219), RELABEL(50436-0219)

PRINCIPAL DISPLAY PANEL

Label Image