TRIAZOLAM- triazolam tablet 
Zydus Lifesciences Limited

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Triazolam Tablets, USP CIV

SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1576-8

Triazolam Tablets USP, 0.125 mg

10 Tablets

Rx only

0.125 mg label

NDC 70771-1162- 8

Triazolam Tablets USP, 0.25 mg

10 Tablets

Rx only

0.25 mg label
TRIAZOLAM 
triazolam tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1162
Route of AdministrationORALDEA ScheduleCIV    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRIAZOLAM (UNII: 1HM943223R) (TRIAZOLAM - UNII:1HM943223R) TRIAZOLAM0.25 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POVIDONE (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorGRAY (light-grayish blue) Score2 pieces
ShapeOVAL (elliptical) Size8mm
FlavorImprint Code 12;89
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1162-810 in 1 BOTTLE; Type 0: Not a Combination Product12/30/2022
2NDC:70771-1162-5500 in 1 BOTTLE; Type 0: Not a Combination Product12/30/2022
3NDC:70771-1162-1100 in 1 BOTTLE; Type 0: Not a Combination Product12/30/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21300312/30/2022
TRIAZOLAM 
triazolam tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1576
Route of AdministrationORALDEA ScheduleCIV    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRIAZOLAM (UNII: 1HM943223R) (TRIAZOLAM - UNII:1HM943223R) TRIAZOLAM0.125 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POVIDONE (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorWHITE (off-white) Scoreno score
ShapeOVAL (elliptical) Size8mm
FlavorImprint Code 1521
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1576-810 in 1 BOTTLE; Type 0: Not a Combination Product12/30/2022
2NDC:70771-1576-5500 in 1 BOTTLE; Type 0: Not a Combination Product12/30/2022
3NDC:70771-1576-1100 in 1 BOTTLE; Type 0: Not a Combination Product12/30/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21300312/30/2022
Labeler - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(70771-1576, 70771-1162) , MANUFACTURE(70771-1576, 70771-1162)

Revised: 9/2023
Document Id: 2fe3e1a1-2ef6-4bd9-8bdf-b5127873c393
Set id: 4084da13-5825-4399-ad69-de701508c71d
Version: 2
Effective Time: 20230928
 
Zydus Lifesciences Limited