NDC Code(s) : 0032-1708-01, 0032-1711-01
Packager : AbbVie Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

PrometriumProgesterone CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0032-1708
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
progesterone(UNII: 4G7DS2Q64Y)
(progesterone - UNII:4G7DS2Q64Y) 		progesterone100 mg
Inactive Ingredients
Ingredient Name Strength
peanut oil(UNII: 5TL50QU0W4)
gelatin(UNII: 2G86QN327L)
glycerin(UNII: PDC6A3C0OX)
lecithin, soybean(UNII: 1DI56QDM62)
titanium dioxide(UNII: 15FIX9V2JP)
D&C yellow no. 10(UNII: 35SW5USQ3G)
FD&C red no. 40(UNII: WZB9127XOA)
Product Characteristics
Color ORANGE (peach) Score no score
Shape ROUND (ROUND) Size 13 mm
Flavor Imprint Code SV
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0032-1708-01100 in 1 BOTTLE Type 0: Not a Combination Product30/07/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019781 07/30/2010 09/30/2018
PrometriumProgesterone CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0032-1711
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
progesterone(UNII: 4G7DS2Q64Y)
(progesterone - UNII:4G7DS2Q64Y) 		progesterone200 mg
Inactive Ingredients
Ingredient Name Strength
peanut oil(UNII: 5TL50QU0W4)
gelatin(UNII: 2G86QN327L)
glycerin(UNII: PDC6A3C0OX)
lecithin, soybean(UNII: 1DI56QDM62)
titanium dioxide(UNII: 15FIX9V2JP)
D&C yellow no. 10(UNII: 35SW5USQ3G)
FD&C yellow no. 6(UNII: H77VEI93A8)
Product Characteristics
Color YELLOW (Pale Yellow) Score no score
Shape OVAL (OVAL) Size 15 mm
Flavor Imprint Code SV2
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0032-1711-01100 in 1 BOTTLE Type 0: Not a Combination Product30/07/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019781 07/30/2010 07/31/2018

PRINCIPAL DISPLAY PANEL

NDC 0032–1708–01

100 Capsules

PROMETRIUM® (progesterone, USP) Capsules 100 mg

Rx only

DO NOT USE IF ALLERGIC TO PEANUTS

abbvie

prometrium 100 mg

NDC 0032–1711–01

100 Capsules

PROMETRIUM® (progesterone, USP) Capsules 200 mg

Rx only

DO NOT USE IF ALLERGIC TO PEANUTS

abbvie

prometrium 100 mg