Acetazolamide: Package Insert and Label Information (Page 2 of 2)

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

NDC 70756-721-11

acetaZOLAMIDE Tablets, USP

250 mg

100 Tablets

Rx only

Manufactured for:

Lifestar Pharma LLC

1200 MacArthur Blvd.

Mahwah, NJ 07430 USA

Made in India

PRINCIPAL DISPLAY PANEL -- 250 mg Tablet Bottle Label
(click image for full-size original)

NDC 70756-721-11

acetaZOLAMIDE Tablets, USP

250 mg

100 Tablets

Rx only

Manufactured in India for:

Lifestar Pharma LLC

1200 MacArthur Blvd.

Mahwah, NJ 07430 USA

Product of Poland

250 mg- Poland
(click image for full-size original)
ACETAZOLAMIDE
acetazolamide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70756-720
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
POVIDONE K30
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
TALC
WATER
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 9mm
Flavor Imprint Code LS;720
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70756-720-11 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214282 11/13/2020
ACETAZOLAMIDE
acetazolamide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70756-721
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
POVIDONE K30
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
TALC
WATER
Product Characteristics
Color WHITE Score 4 pieces
Shape ROUND Size 11mm
Flavor Imprint Code LS;721
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70756-721-11 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214282 11/13/2020
Labeler — Lifestar Pharma LLC (080268943)
Registrant — Mankind Pharma Limited (915834068)
Establishment
Name Address ID/FEI Operations
Mankind Pharma Limited 916512493 MANUFACTURE (70756-720), MANUFACTURE (70756-721), ANALYSIS (70756-720), ANALYSIS (70756-721), PACK (70756-720), PACK (70756-721)

Revised: 11/2020 Lifestar Pharma LLC

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