NDC Code(s) : 43598-349-99, 43598-350-69
Packager : Dr. Reddy’s Laboratories, 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:43598-349
Route of Administration NOT APPLICABLE 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)
Ammonia(UNII: 5138Q19F1X)
Ferrosoferric Oxide(UNII: XM0M87F357)
Propylene Glycol(UNII: 6DC9Q167V3)
Shellac(UNII: 46N107B71O)
Product Characteristics
Color ORANGE (Peach) Score no score
Shape ROUND Size 9 mm
Flavor Imprint Code P1
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43598-349-9925000 in 1 POUCH 25/03/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Export only ANDA208801 03/25/2017
ProgesteroneProgesterone CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43598-350
Route of Administration NOT APPLICABLE 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)
Ammonia(UNII: 5138Q19F1X)
Ferrosoferric Oxide(UNII: XM0M87F357)
Propylene Glycol(UNII: 6DC9Q167V3)
Shellac(UNII: 46N107B71O)
Product Characteristics
Color YELLOW (Pale Yellow) Score no score
Shape OVAL Size 15 mm
Flavor Imprint Code P2
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43598-350-6912000 in 1 POUCH 25/03/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Export only ANDA208801 03/25/2017

PRINCIPAL DISPLAY PANEL

PRODUCT: Progesterone Capsules, 100 mg

Count : 25,000 Capsules

NDC: 43598-349-99

STORAGE: 15 °C - 25 °C

Mfg Date: 10-Jan-2000

Bulk Expiry Date:09-Jul-2017

CODE: JB16291010

QUANTITY: 1X25000

CAUTION : Rx only for FURTHER MANUFACTURING,PROCESSING, OR REPACKING

BY: Dr. Reddy’s Laboratories, Inc.

This is a bulk pack and not intended for long-term storage.

Re-packaging should be done within 2 months after delivery.

Capsule should be repackaged in moisture and vapour-proof pack.

PRINCIPAL DISPLAY PANEL

PRODUCT: Progesterone Capsules, 200 mg

Count : 12,000 Capsules

NDC: 43598-350-69

STORAGE: 15 °C - 25 °C

Mfg Date: 10-Jan-2000

Bulk Expiry Date:09-Jul-2000

CODE: JB16291010

QUANTITY: 1X12000

CAUTION : Rx only for FURTHER MANUFACTURING,PROCESSING, OR REPACKING

BY: Dr. Reddy’s Laboratories, Inc.

This is a bulk pack and not intended for long-term storage.

Re-packaging should be done within 2 months after delivery.

Capsule should be repackaged in moisture and vapour-proof pack.