Triazolam by Zydus Lifesciences Limited TRIAZOLAM tablet

Triazolam by

Drug Labeling and Warnings

Triazolam by is a Prescription medication manufactured, distributed, or labeled by Zydus Lifesciences Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 70771-1576-1

Triazolam Tablets USP, 0.125 mg

100 Tablets

Rx only

NDC: 70771-1162- 1

Triazolam Tablets USP, 0.25 mg

100 Tablets

Rx only

INGREDIENTS AND APPEARANCE

TRIAZOLAM 
triazolam tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1162
Route of Administration	ORAL	DEA Schedule	CIV

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRIAZOLAM (UNII: 1HM943223R) (TRIAZOLAM - UNII:1HM943223R)	TRIAZOLAM	0.25 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	GRAY (light-grayish blue)	Score	2 pieces
Shape	OVAL (elliptical)	Size	8mm
Flavor		Imprint Code	12;89
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1162-8	10 in 1 BOTTLE; Type 0: Not a Combination Product	12/30/2022
2	NDC: 70771-1162-5	500 in 1 BOTTLE; Type 0: Not a Combination Product	12/30/2022
3	NDC: 70771-1162-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	12/30/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA213003	12/30/2022

TRIAZOLAM 
triazolam tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1576
Route of Administration	ORAL	DEA Schedule	CIV

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRIAZOLAM (UNII: 1HM943223R) (TRIAZOLAM - UNII:1HM943223R)	TRIAZOLAM	0.125 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE (off-white)	Score	no score
Shape	OVAL (elliptical)	Size	8mm
Flavor		Imprint Code	1521
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1576-8	10 in 1 BOTTLE; Type 0: Not a Combination Product	12/30/2022
2	NDC: 70771-1576-5	500 in 1 BOTTLE; Type 0: Not a Combination Product	12/30/2022
3	NDC: 70771-1576-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	12/30/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA213003	12/30/2022

Labeler - Zydus Lifesciences Limited (918596198)

Establishment
Name	Address	ID/FEI	Business Operations
Zydus Lifesciences Limited		918596198	ANALYSIS(70771-1576, 70771-1162) , MANUFACTURE(70771-1576, 70771-1162)