Misoprostol (Page 5 of 5)

PRINCIPAL DISPLAY PANEL

100 mcg – Label

NDC 40032-160-06

Misoprostol

Tablets

100 mcg

Rx only

60 TABLETS

9023f150-figure-02
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200 mcg Label

NDC 40032-161-06

Misoprostol

Tablets

200 mcg

Rx only

60 TABLETS

9023f150-figure-03
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MISOPROSTOL misoprostol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:40032-160
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
HYDROGENATED CASTOR OIL
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE
Product Characteristics
Color white Score no score
Shape ROUND Size 6mm
Flavor Imprint Code 160;n
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:40032-160-06 60 TABLET in 1 BOTTLE None
2 NDC:40032-160-12 120 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091667 07/25/2012
MISOPROSTOL misoprostol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:40032-161
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
HYDROGENATED CASTOR OIL
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE
Product Characteristics
Color white Score 2 pieces
Shape ROUND Size 9mm
Flavor Imprint Code 161;n
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:40032-161-06 60 TABLET in 1 BOTTLE None
2 NDC:40032-161-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091667 07/25/2012
Labeler — Novel Laboratories, Inc. (793518643)
Registrant — Novel Laboratories, Inc. (793518643)
Establishment
Name Address ID/FEI Operations
Novel Laboratories, Inc. 793518643 analysis (40032-160), analysis (40032-161), manufacture (40032-160), manufacture (40032-161)

Revised: 12/2020 Novel Laboratories, Inc.

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