Misoprostol (Page 4 of 4)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Misoprostol Tablets, 100 mcg

NDC 70954-443-10 — unit-of-use bottle of 60

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Misoprostol Tablets, 100 mcg

NDC 70954-443-20 — unit-of-use bottle of 120

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Misoprostol Tablets, 200 mcg

NDC 70954-444-10 — unit-of-use bottle of 60

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Misoprostol Tablets, 200 mcg

NDC 70954-444-20 — unit-of-use bottle of 100

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MISOPROSTOL misoprostol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70954-443
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MISOPROSTOL (MISOPROSTOL) MISOPROSTOL 100 ug
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
HYPROMELLOSES
HYDROGENATED COTTONSEED OIL
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 7mm
Flavor Imprint Code 443;N
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70954-443-10 60 TABLET in 1 BOTTLE None
2 NDC:70954-443-20 120 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076095 04/11/2022
MISOPROSTOL misoprostol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70954-444
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MISOPROSTOL (MISOPROSTOL) MISOPROSTOL 200 ug
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
HYPROMELLOSES
HYDROGENATED COTTONSEED OIL
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 9mm
Flavor Imprint Code N444
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70954-444-10 60 TABLET in 1 BOTTLE None
2 NDC:70954-444-20 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076095 04/11/2022
Labeler — Novitium Pharma LLC (080301870)

Revised: 04/2022 Novitium Pharma LLC

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