Doxazosin (Page 6 of 6)

PRINCIPAL DISPLAY PANEL

Doxazosin Tablets USP

1 mg

Doxazosin Tablets USP

2 mg

Doxazosin Tablets USP

4 mg

Doxazosin Tablets USP

8 mg

DOXAZOSIN doxazosin tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16729-414 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOXAZOSIN MESYLATE (DOXAZOSIN) DOXAZOSIN 2 mg

Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE LACTOSE MONOHYDRATE SODIUM STARCH GLYCOLATE TYPE A POTATO SODIUM LAURYL SULFATE FERRIC OXIDE YELLOW

Product Characteristics Color yellow (Cream to yellow) Score 2 pieces Shape ROUND Size 7mm Flavor Imprint Code C7 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:16729-414-01 100 TABLET in 1 BOTTLE None 2 NDC:16729-414-17 1000 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA202824 06/14/2017

DOXAZOSIN doxazosin tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16729-211 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOXAZOSIN MESYLATE (DOXAZOSIN) DOXAZOSIN 1 mg

Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE LACTOSE MONOHYDRATE SODIUM STARCH GLYCOLATE TYPE A POTATO SODIUM LAURYL SULFATE

Product Characteristics Color white (White to off white) Score 2 pieces Shape ROUND Size 7mm Flavor Imprint Code C3 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:16729-211-01 100 TABLET in 1 BOTTLE None 2 NDC:16729-211-17 1000 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA202824 03/04/2015

DOXAZOSIN doxazosin tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16729-213 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOXAZOSIN MESYLATE (DOXAZOSIN) DOXAZOSIN 4 mg

Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE LACTOSE MONOHYDRATE SODIUM STARCH GLYCOLATE TYPE A POTATO SODIUM LAURYL SULFATE FERRIC OXIDE YELLOW

Product Characteristics Color yellow (Cream to yellow) Score 2 pieces Shape ROUND Size 10mm Flavor Imprint Code C4 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:16729-213-01 100 TABLET in 1 BOTTLE None 2 NDC:16729-213-17 1000 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA202824 04/22/2015

DOXAZOSIN doxazosin tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16729-415 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOXAZOSIN MESYLATE (DOXAZOSIN) DOXAZOSIN 8 mg

Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE LACTOSE MONOHYDRATE SODIUM STARCH GLYCOLATE TYPE A POTATO SODIUM LAURYL SULFATE

Product Characteristics Color white ( White to off white ) Score 2 pieces Shape ROUND Size 10mm Flavor Imprint Code C5 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:16729-415-01 100 TABLET in 1 BOTTLE None 2 NDC:16729-415-17 1000 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA202824 07/10/2017

Labeler — Accord Healthcare Inc. (604222237)

Registrant — Accord Healthcare Inc. (604222237)

Establishment
Name	Address	ID/FEI	Operations
Intas Pharmaceuticals Limited.		725927649	manufacture (16729-211), manufacture (16729-414), manufacture (16729-213), manufacture (16729-415), analysis (16729-211), analysis (16729-414), analysis (16729-213), analysis (16729-415)

Establishment
Name	Address	ID/FEI	Operations
Intas Pharmaceuticals Limited.		915837971	manufacture (16729-211), manufacture (16729-414), manufacture (16729-213), manufacture (16729-415), analysis (16729-211), analysis (16729-414), analysis (16729-213), analysis (16729-415)

Revised: 03/2023 Accord Healthcare Inc.