PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1112-1 in bottle of 100 Tablets

Doxazosin Tablets USP, 1 mg

Rx only

100 Tablets

NDC 70771-1113-1 in bottle of 100 Tablets

Doxazosin Tablets USP, 2 mg

Rx only

100 Tablets

NDC 70771-1114-1 in bottle of 100 Tablets

Doxazosin Tablets USP, 4 mg

Rx only

100 Tablets

NDC 70771-1115-1 in bottle of 100 Tablets

Doxazosin Tablets USP, 8 mg

Rx only

100 Tablets

DOXAZOSIN
doxazosin tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1112
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DOXAZOSIN MESYLATE (UNII: 86P6PQK0MU) (DOXAZOSIN - UNII:NW1291F1W8)	DOXAZOSIN	1 mg

Ingredient Name	Strength
Inactive Ingredients
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	WHITE (WHITE TO OFF-WHITE)	Score	2 pieces
Shape	ROUND (ROUND BICONVEX)	Size	7mm
Flavor		Imprint Code	783
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1112-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	08/31/2017
2	NDC:70771-1112-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	08/31/2017
3	NDC:70771-1112-0	1000 in 1 BOTTLE; Type 0: Not a Combination Product	08/31/2017
4	NDC:70771-1112-4	10 in 1 CARTON	08/31/2017
4	NDC:70771-1112-2	10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA208719	08/31/2017

DOXAZOSIN
doxazosin tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1113
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DOXAZOSIN MESYLATE (UNII: 86P6PQK0MU) (DOXAZOSIN - UNII:NW1291F1W8)	DOXAZOSIN	2 mg

Ingredient Name	Strength
Inactive Ingredients
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
FERRIC OXIDE RED (UNII: 1K09F3G675)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	PINK (LIGHT PINK TO PINK)	Score	2 pieces
Shape	ROUND (ROUND BICONVEX)	Size	7mm
Flavor		Imprint Code	784
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1113-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	08/31/2017
2	NDC:70771-1113-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	08/31/2017
3	NDC:70771-1113-0	1000 in 1 BOTTLE; Type 0: Not a Combination Product	08/31/2017
4	NDC:70771-1113-4	10 in 1 CARTON	08/31/2017
4	NDC:70771-1113-2	10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA208719	08/31/2017

DOXAZOSIN
doxazosin tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1114
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DOXAZOSIN MESYLATE (UNII: 86P6PQK0MU) (DOXAZOSIN - UNII:NW1291F1W8)	DOXAZOSIN	4 mg

Ingredient Name	Strength
Inactive Ingredients
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
FERRIC OXIDE RED (UNII: 1K09F3G675)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	PINK (LIGHT PINK TO PINK)	Score	2 pieces
Shape	CAPSULE (CAPSULE, BICONVEX)	Size	12mm
Flavor		Imprint Code	785
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1114-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	08/31/2017
2	NDC:70771-1114-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	08/31/2017
3	NDC:70771-1114-0	1000 in 1 BOTTLE; Type 0: Not a Combination Product	08/31/2017
4	NDC:70771-1114-4	10 in 1 CARTON	08/31/2017
4	NDC:70771-1114-2	10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA208719	08/31/2017

DOXAZOSIN
doxazosin tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1115
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DOXAZOSIN MESYLATE (UNII: 86P6PQK0MU) (DOXAZOSIN - UNII:NW1291F1W8)	DOXAZOSIN	8 mg

Ingredient Name	Strength
Inactive Ingredients
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FD&C RED NO. 40 (UNII: WZB9127XOA)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	PURPLE (LIGHT PURPLE TO PURPLE)	Score	2 pieces
Shape	ROUND (ROUND BICONVEX)	Size	9mm
Flavor		Imprint Code	786
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1115-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	08/31/2017
2	NDC:70771-1115-0	1000 in 1 BOTTLE; Type 0: Not a Combination Product	08/31/2017
3	NDC:70771-1115-4	10 in 1 CARTON	08/31/2017
3	NDC:70771-1115-2	10 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC:70771-1115-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	08/31/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA208719	08/31/2017

Labeler - Zydus Lifesciences Limited (918596198)

Registrant - Zydus Lifesciences Limited (918596198)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		863362789	ANALYSIS(70771-1112, 70771-1113, 70771-1114, 70771-1115) , MANUFACTURE(70771-1112, 70771-1113, 70771-1114, 70771-1115)

DOXAZOSIN TABLETS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL