NDC Code(s) : 60429-566-01, 60429-567-01
Packager : Golden State Medical Supply, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CIV

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

EstazolamEstazolam TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-566(NDC:0591-0744)
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESTAZOLAM(UNII: 36S3EQV54C)
(ESTAZOLAM - UNII:36S3EQV54C) 		ESTAZOLAM1 mg
Inactive Ingredients
Ingredient Name Strength
DOCUSATE SODIUM(UNII: F05Q2T2JA0)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SODIUM BENZOATE(UNII: OJ245FE5EU)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
STEARIC ACID(UNII: 4ELV7Z65AP)
Product Characteristics
Color WHITE Score 2 pieces
Shape DIAMOND Size 9 mm
Flavor Imprint Code WATSON;744;1
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60429-566-01100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product19/08/1997
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074818 08/19/1997 12/31/2013
EstazolamEstazolam TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-567(NDC:0591-0745)
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESTAZOLAM(UNII: 36S3EQV54C)
(ESTAZOLAM - UNII:36S3EQV54C) 		ESTAZOLAM2 mg
Inactive Ingredients
Ingredient Name Strength
DOCUSATE SODIUM(UNII: F05Q2T2JA0)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SODIUM BENZOATE(UNII: OJ245FE5EU)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
STEARIC ACID(UNII: 4ELV7Z65AP)
FD&C RED NO. 40(UNII: WZB9127XOA)
ALUMINUM OXIDE(UNII: LMI26O6933)
Product Characteristics
Color PINK (dark pink) Score 2 pieces
Shape DIAMOND Size 9 mm
Flavor Imprint Code WATSON;745;2
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60429-567-01100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product19/08/1997
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074818 08/19/1997 12/31/2013

PRINCIPAL DISPLAY PANEL

NDC 60429-566-01
CIV
Estazolam Tablets, USP
1mg
PHARMACIST: Dispense the
accompanying Medication
Guide to each patient.

GSMS     
100 Tablets
Rx Only

Label Graphic-Estazolam 1mg 100s

PRINCIPAL DISPLAY PANEL

NDC 60429-567-01
CIV
Estazolam Tablets, USP
2mg
PHARMACIST: Dispense the
accompanying Medication
Guide to each patient.

GSMS
100 Tablets
Rx Only

Label Graphic-Estazolam 2mg