OMEPRAZOLE MAGNESIUM- omeprazole magnesium capsule, delayed release 
Dr. Reddy's Laboratories Limited

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Omeprazole Magnesium DR Capsules 20.6 mg

PRINCIPAL DISPLAY PANEL - Pouch Label

DR. REDDY'S

NDC 55111-397-89
Count :
1,500 Capsules

Omeprazole Magnesium Delayed-Release Capsules 20.6 mg
(equivalent to 20 mg omeprazole)

Batch No. :

Mfg. Date :

Repack Before :

Expiration Date :

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]

Caution: For manufacturing, processing or repackaging only.

DO NOT OPEN POUCHES UNTIL REPACKAGING

Mfd. by : Dr. Reddy's Laboratories Limited
Bachupally - 500 090 INDIA

150071750

M.L. 59/RR/AP/97/F/R

Omeprazole_Foil Pouch

Omeprazole_Foil Pouch

OMEPRAZOLE MAGNESIUM 
omeprazole magnesium capsule, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55111-397
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Omeprazole Magnesium (UNII: 426QFE7XLK) (Omeprazole - UNII:KG60484QX9) Omeprazole20 mg
Inactive Ingredients
Ingredient NameStrength
Ferrosoferric Oxide (UNII: XM0M87F357)  
Anhydrous Dibasic Calcium Phosphate (UNII: L11K75P92J)  
Gelatin (UNII: 2G86QN327L)  
Glyceryl Monostearate (UNII: 230OU9XXE4)  
Hypromellose 2910 (3 Mpa.S) (UNII: 0VUT3PMY82)  
Magnesium Oxide (UNII: 3A3U0GI71G)  
Magnesium Stearate (UNII: 70097M6I30)  
Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type A (UNII: NX76LV5T8J)  
Methacrylic Acid - Methyl Methacrylate Copolymer (1:2) (UNII: 5KY68S2577)  
Cellulose, Microcrystalline (UNII: OP1R32D61U)  
Polysorbate 80 (UNII: 6OZP39ZG8H)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Shellac (UNII: 46N107B71O)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Sodium Lauryl Sulfate (UNII: 368GB5141J)  
Talc (UNII: 7SEV7J4R1U)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Ferric Oxide Red (UNII: 1K09F3G675)  
Raw Sugar (UNII: 8M707QY5GH)  
Potassium Hydroxide (UNII: WZH3C48M4T)  
Triethyl Citrate (UNII: 8Z96QXD6UM)  
Product Characteristics
ColorWHITE, PINKScoreno score
ShapeCAPSULESize22mm
FlavorImprint Code OMP20
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55111-397-891500 in 1 POUCH; Type 0: Not a Combination Product11/12/2009
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only11/12/2009
Labeler - Dr. Reddy's Laboratories Limited (650562841)
Establishment
NameAddressID/FEIBusiness Operations
Dr. Reddy's Laboratories Limited918608162analysis(55111-397) , manufacture(55111-397)

Revised: 2/2020
Document Id: 879ff4a5-833c-f57b-3970-aeed17688cac
Set id: fe870574-6a7c-5fbb-999e-80ad5af1799b
Version: 4
Effective Time: 20200204
 
Dr. Reddy's Laboratories Limited