PROGESTERONE- progesterone capsule 
Dr. Reddy’s Laboratories, Inc.

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Progesterone Capsules, 100 mg and 200 mg

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.

label-01

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.

label-02

PROGESTERONE 
progesterone capsule
Product Information
Product TypeBULK INGREDIENTItem Code (Source)NDC:43598-349
Route of AdministrationNOT APPLICABLE
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Progesterone (UNII: 4G7DS2Q64Y) (Progesterone - UNII:4G7DS2Q64Y) Progesterone100 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorORANGE (Peach) Scoreno score
ShapeROUNDSize9mm
FlavorImprint Code P1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43598-349-9925000 in 1 POUCH03/25/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export onlyANDA20880103/25/2017
PROGESTERONE 
progesterone capsule
Product Information
Product TypeBULK INGREDIENTItem Code (Source)NDC:43598-350
Route of AdministrationNOT APPLICABLE
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Progesterone (UNII: 4G7DS2Q64Y) (Progesterone - UNII:4G7DS2Q64Y) Progesterone200 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorYELLOW (Pale Yellow) Scoreno score
ShapeOVALSize15mm
FlavorImprint Code P2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43598-350-6912000 in 1 POUCH03/25/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export onlyANDA20880103/25/2017
Labeler - Dr. Reddy’s Laboratories, Inc. (802315887)
Establishment
NameAddressID/FEIBusiness Operations
Capsugel Ploermel493010524repack(43598-349, 43598-350) , manufacture(43598-349, 43598-350) , api manufacture(43598-349, 43598-350)

Revised: 3/2017
Document Id: b6e4a58d-d039-e7a4-d2b0-6832adb51782
Set id: 3788659e-f4ee-7d4f-2ae1-947df971d7bf
Version: 6
Effective Time: 20170314
 
Dr. Reddy’s Laboratories, Inc.