TRAZODONE HYDROCHLORIDE- trazodone hydrochloride tablet 
Cadila Healthcare Limited

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TRAZODONE HYDROCHLORIDE TABLETS

SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1128-1

Trazodone Hydrochloride Tablets USP, 50 mg

100 Tablets

Rx only

Trazodone Hyadrochloride Tablets, USP

NDC 70771-1129-1

Trazodone Hydrochloride Tablets USP, 100 mg

100 Tablets

Rx only

Trazodone Hyadrochloride Tablets, USP

NDC 70771-1130-1

Trazodone Hydrochloride Tablets USP, 150 mg

100 Tablets

Rx only

Trazodone Hyadrochloride Tablets, USP

NDC 70771-1131-1

Trazodone Hydrochloride Tablets USP, 300 mg

100 Tablets

Rx only

Trazodone Hyadrochloride Tablets, USP
TRAZODONE HYDROCHLORIDE 
trazodone hydrochloride tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1128
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRAZODONE HYDROCHLORIDE (UNII: 6E8ZO8LRNM) (TRAZODONE - UNII:YBK48BXK30) TRAZODONE HYDROCHLORIDE50 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Score2 pieces
ShapeROUND (ROUND) Size8mm
FlavorImprint Code 8;05
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1128-990 in 1 BOTTLE; Type 0: Not a Combination Product12/11/2017
2NDC:70771-1128-1100 in 1 BOTTLE; Type 0: Not a Combination Product12/11/2017
3NDC:70771-1128-5500 in 1 BOTTLE; Type 0: Not a Combination Product12/11/2017
4NDC:70771-1128-01000 in 1 BOTTLE; Type 0: Not a Combination Product12/11/2017
5NDC:70771-1128-410 in 1 CARTON12/11/2017
5NDC:70771-1128-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
6NDC:70771-1128-330 in 1 BOTTLE; Type 0: Not a Combination Product12/11/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20525312/11/2017
TRAZODONE HYDROCHLORIDE 
trazodone hydrochloride tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1129
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRAZODONE HYDROCHLORIDE (UNII: 6E8ZO8LRNM) (TRAZODONE - UNII:YBK48BXK30) TRAZODONE HYDROCHLORIDE100 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Score2 pieces
ShapeROUND (ROUND) Size10mm
FlavorImprint Code 8;06
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1129-330 in 1 BOTTLE; Type 0: Not a Combination Product12/11/2017
2NDC:70771-1129-990 in 1 BOTTLE; Type 0: Not a Combination Product12/11/2017
3NDC:70771-1129-1100 in 1 BOTTLE; Type 0: Not a Combination Product12/11/2017
4NDC:70771-1129-5500 in 1 BOTTLE; Type 0: Not a Combination Product12/11/2017
5NDC:70771-1129-01000 in 1 BOTTLE; Type 0: Not a Combination Product12/11/2017
6NDC:70771-1129-410 in 1 CARTON12/11/2017
6NDC:70771-1129-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20525312/11/2017
TRAZODONE HYDROCHLORIDE 
trazodone hydrochloride tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1130
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRAZODONE HYDROCHLORIDE (UNII: 6E8ZO8LRNM) (TRAZODONE - UNII:YBK48BXK30) TRAZODONE HYDROCHLORIDE150 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Score3 pieces
ShapeOVAL (OVAL) Size17mm
FlavorImprint Code 8;07
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1130-330 in 1 BOTTLE; Type 0: Not a Combination Product12/11/2017
2NDC:70771-1130-990 in 1 BOTTLE; Type 0: Not a Combination Product12/11/2017
3NDC:70771-1130-1100 in 1 BOTTLE; Type 0: Not a Combination Product12/11/2017
4NDC:70771-1130-5500 in 1 BOTTLE; Type 0: Not a Combination Product12/11/2017
5NDC:70771-1130-01000 in 1 BOTTLE; Type 0: Not a Combination Product12/11/2017
6NDC:70771-1130-410 in 1 CARTON12/11/2017
6NDC:70771-1130-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20525312/11/2017
TRAZODONE HYDROCHLORIDE 
trazodone hydrochloride tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1131
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRAZODONE HYDROCHLORIDE (UNII: 6E8ZO8LRNM) (TRAZODONE - UNII:YBK48BXK30) TRAZODONE HYDROCHLORIDE300 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Score3 pieces
ShapeOVAL (OVAL) Size21mm
FlavorImprint Code 8;08
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1131-330 in 1 BOTTLE; Type 1: Convenience Kit of Co-Package12/11/2017
2NDC:70771-1131-990 in 1 BOTTLE; Type 0: Not a Combination Product12/11/2017
3NDC:70771-1131-1100 in 1 BOTTLE; Type 0: Not a Combination Product12/11/2017
4NDC:70771-1131-5500 in 1 BOTTLE; Type 0: Not a Combination Product12/11/2017
5NDC:70771-1131-01000 in 1 BOTTLE; Type 0: Not a Combination Product12/11/2017
6NDC:70771-1131-410 in 1 CARTON12/11/2017
6NDC:70771-1131-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20525312/11/2017
Labeler - Cadila Healthcare Limited (918596198)
Registrant - Cadila Healthcare Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Cadila Healthcare Limited863362789ANALYSIS(70771-1128, 70771-1129, 70771-1130, 70771-1131) , MANUFACTURE(70771-1128, 70771-1129, 70771-1130, 70771-1131)

Revised: 9/2020
Document Id: b87b8659-5cd7-4658-9764-0455dc75e1b4
Set id: 43d4be17-5fae-4326-a5c4-9e25e2db6a43
Version: 4
Effective Time: 20200914
 
Cadila Healthcare Limited