OMEPRAZOLE MAGNESIUM capsule, delayed release

Omeprazole Magnesium by

Drug Labeling and Warnings

Omeprazole Magnesium by is a Otc medication manufactured, distributed, or labeled by Dr. Reddy's Laboratories Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

INGREDIENTS AND APPEARANCE

OMEPRAZOLE MAGNESIUM 
omeprazole magnesium capsule, delayed release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55111-397
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Omeprazole Magnesium (UNII: 426QFE7XLK) (Omeprazole - UNII:KG60484QX9)	Omeprazole	20 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE, PINK	Score	no score
Shape	CAPSULE	Size	22mm
Flavor		Imprint Code	OMP20
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55111-397-89	1500 in 1 POUCH; Type 0: Not a Combination Product	11/12/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Export only		11/12/2009

Labeler - Dr. Reddy's Laboratories Limited (650562841)

Establishment
Name	Address	ID/FEI	Business Operations
Dr. Reddy's Laboratories Limited		918608162	analysis(55111-397) , manufacture(55111-397)