Acetazolamide (Page 3 of 3)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 27241-132-04
100 Tablets
AcetaZOLAMIDE Tablets, USP
125 mg
Rx Only
ajanta

acetazolamide_125mg
(click image for full-size original)

NDC 27241-133-04
100 Tablets
AcetaZOLAMIDE Tablets, USP
250 mg
Rx Only
ajanta

acetazolamide_250mg
(click image for full-size original)
ACETAZOLAMIDE
acetazolamide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:27241-132
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
STARCH, CORN
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
MAGNESIUM STEARATE
WATER
SODIUM STARCH GLYCOLATE TYPE A POTATO
POVIDONE
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 9mm
Flavor Imprint Code A3
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:27241-132-04 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211151 09/11/2023
ACETAZOLAMIDE
acetazolamide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:27241-133
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
STARCH, CORN
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
MAGNESIUM STEARATE
WATER
SODIUM STARCH GLYCOLATE TYPE A POTATO
POVIDONE
Product Characteristics
Color WHITE Score 4 pieces
Shape ROUND Size 11mm
Flavor Imprint Code A4
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:27241-133-04 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211151 09/11/2023
Labeler — Ajanta Pharma USA Inc. (557554156)
Registrant — Ajanta Pharma Limited, Paithan (918594859)
Establishment
Name Address ID/FEI Operations
Ajanta Pharma Limited, Paithan 918594859 MANUFACTURE (27241-132), MANUFACTURE (27241-133)

Revised: 08/2023 Ajanta Pharma USA Inc.

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