NDC Code(s) : 60429-936-40, 60429-936-05, 60429-939-40, 60429-939-05
Packager : Golden State Medical Supply, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CephalexinCephalexin CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-936(NDC:61442-161)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Cephalexin(UNII: OBN7UDS42Y)
(CEPHALEXIN ANHYDROUS - UNII:5SFF1W6677) 		CEPHALEXIN ANHYDROUS250 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE(UNII: 70097M6I30)
SODIUM STARCH GLYCOLATE TYPE B POTATO(UNII: 27NA468985)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
TALC(UNII: 7SEV7J4R1U)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
GELATIN(UNII: 2G86QN327L)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C YELLOW NO. 5(UNII: I753WB2F1M)
SHELLAC(UNII: 46N107B71O)
ALCOHOL(UNII: 3K9958V90M)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
BUTYL ALCOHOL(UNII: 8PJ61P6TS3)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
WATER(UNII: 059QF0KO0R)
AMMONIA(UNII: 5138Q19F1X)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
Product Characteristics
Color GREEN (Deep Green Cap) Score no score
Shape CAPSULE (Pale Green Body) Size 2 mm
Flavor Imprint Code CCC;250
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60429-936-4040 in 1 BOTTLE
2NDC:60429-936-05500 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065152 02/24/2005
CephalexinCephalexin CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-939(NDC:61442-162)
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
MAGNESIUM STEARATE(UNII: 70097M6I30)
SODIUM STARCH GLYCOLATE TYPE B POTATO(UNII: 27NA468985)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
TALC(UNII: 7SEV7J4R1U)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
GELATIN(UNII: 2G86QN327L)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C YELLOW NO. 5(UNII: I753WB2F1M)
SHELLAC(UNII: 46N107B71O)
ALCOHOL(UNII: 3K9958V90M)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
BUTYL ALCOHOL(UNII: 8PJ61P6TS3)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
WATER(UNII: 059QF0KO0R)
AMMONIA(UNII: 5138Q19F1X)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
Product Characteristics
Color GREEN (Green Cap) Score no score
Shape CAPSULE (Pale Green Body) Size 2 mm
Flavor Imprint Code CCC;500
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60429-939-4040 in 1 BOTTLE
2NDC:60429-939-05500 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065152 02/24/2005

PRINCIPAL DISPLAY PANEL

NDC 60429-936-40

CEPHALEXIN

Capsules

250 mg

Rx Only

GSMS, Inc.

Label Graphic - 250 mg 40s

PRINCIPAL DISPLAY PANEL

NDC 60429-939-40

CEPHALEXIN

Capsules

500 mg

Rx Only

GSMS, Inc.

Label Graphic - 500 mg 40s