LANSOPRAZOLE - lansoprazole tablet, orally disintegrating 
Zydus Lifesciences Limited

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LANSOPRAZOLE DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1132-4

Lansoprazole Delayed-release Orally Disintegrating Tablets, 15 mg

Rx only

100 Tablets (10 x 10 Unit Dose)

Lansoprazole delayed-release orally disintegrating tablets, 15 mg

NDC 70771-1133-4

Lansoprazole Delayed-release Orally Disintegrating Tablets, 30 mg

Rx only

100 Tablets (10 x 10 Unit Dose)

Lansoprazole delayed-release orally disintegrating tablets, 30 mg
LANSOPRAZOLE 
lansoprazole tablet, orally disintegrating
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1132
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LANSOPRAZOLE (UNII: 0K5C5T2QPG) (LANSOPRAZOLE - UNII:0K5C5T2QPG) LANSOPRAZOLE15 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
ASPARTAME (UNII: Z0H242BBR1)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM CARBONATE (UNII: 0E53J927NA)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)  
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STARCH, CORN (UNII: O8232NY3SJ)  
STRAWBERRY (UNII: 4J2TY8Y81V)  
TALC (UNII: 7SEV7J4R1U)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeROUND (ROUND) Size10mm
FlavorSTRAWBERRY (STRAWBERRY) Imprint Code 771
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1132-410 in 1 CARTON11/30/2018
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20081611/30/2018
LANSOPRAZOLE 
lansoprazole tablet, orally disintegrating
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1133
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LANSOPRAZOLE (UNII: 0K5C5T2QPG) (LANSOPRAZOLE - UNII:0K5C5T2QPG) LANSOPRAZOLE30 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
ASPARTAME (UNII: Z0H242BBR1)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM CARBONATE (UNII: 0E53J927NA)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)  
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STARCH, CORN (UNII: O8232NY3SJ)  
STRAWBERRY (UNII: 4J2TY8Y81V)  
TALC (UNII: 7SEV7J4R1U)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeROUND (ROUND) Size13mm
FlavorSTRAWBERRY (STRAWBERRY) Imprint Code 772
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1133-410 in 1 CARTON11/30/2018
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20081611/30/2018
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(70771-1132, 70771-1133) , MANUFACTURE(70771-1132, 70771-1133)

Revised: 10/2022
Document Id: 92d1ddb6-f7af-49c0-b490-2794c8caefbc
Set id: 76ffd38e-bea8-45a0-b6bd-82f0043ce64d
Version: 4
Effective Time: 20221018
 
Zydus Lifesciences Limited