Acetazolamide (Page 3 of 3)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 250 MG (1000 TABLETS)

NDC 23155-288 -10

AcetaZOLAMIDE Tablets, USP

250 mg

1000 Tablets

Rx Only

label 250 mg 1000 tablets
(click image for full-size original)
ACETAZOLAMIDE
acetazolamide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:23155-287
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAZOLAMIDE (ACETAZOLAMIDE) ACETAZOLAMIDE 125 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE
STARCH, CORN
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 9mm
Flavor Imprint Code HP;287
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:23155-287-10 1000 TABLET in 1 BOTTLE None
2 NDC:23155-287-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205530 10/27/2016
ACETAZOLAMIDE
acetazolamide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:23155-288
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAZOLAMIDE (ACETAZOLAMIDE) ACETAZOLAMIDE 250 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE
STARCH, CORN
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color WHITE Score 4 pieces
Shape ROUND Size 11mm
Flavor Imprint Code HP;288
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:23155-288-01 100 TABLET in 1 BOTTLE None
2 NDC:23155-288-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205530 10/27/2016
Labeler — Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. (780779901)
Registrant — Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc. (189630168)
Establishment
Name Address ID/FEI Operations
Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc. 189630168 ANALYSIS (23155-287), ANALYSIS (23155-288), LABEL (23155-287), LABEL (23155-288), MANUFACTURE (23155-287), MANUFACTURE (23155-288), PACK (23155-287), PACK (23155-288)

Revised: 04/2022 Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

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