NDC Code(s) : 43063-649-30
Packager : PD-Rx Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ProgesteroneProgesterone CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43063-649(NDC:0591-3965)
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:43063-649-3030 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product12/01/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019781 07/30/2010

PRINCIPAL DISPLAY PANEL

Progesterone, USP Capsules 200 mg

DO NOT USE IF ALLERGIC TO PEANUTS

43063649 Label