PROMETHAZINE HYDROCHLORIDE- promethazine hydrochloride tablet 
Zydus Lifesciences Limited

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Promethazine Hydrochloride Tablets USP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-040-01 in bottle of 100 tablets

Promethazine Hydrochloride Tablets USP, 12.5 mg

Rx only

100 tablets

Promethzine Tablets, 12.5 mg

NDC 65841-041-01 in bottle of 100 tablets

Promethazine Hydrochloride Tablets USP, 25 mg

Rx only

100 tablets

Promethazine Tablets, 25 mg

NDC 65841-042-01 in bottle of 100 tablets

Promethazine Hydrochloride Tablets USP, 50 mg

Rx only

100 tablets

Promethazine Tablets, 50 mg
PROMETHAZINE HYDROCHLORIDE 
promethazine hydrochloride tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-040
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PROMETHAZINE HYDROCHLORIDE (UNII: R61ZEH7I1I) (PROMETHAZINE - UNII:FF28EJQ494) PROMETHAZINE HYDROCHLORIDE12.5 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Score2 pieces
ShapeROUND (ROUND) Size6mm
FlavorImprint Code ZC;01
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-040-01100 in 1 BOTTLE; Type 0: Not a Combination Product12/14/2005
2NDC:65841-040-05500 in 1 BOTTLE; Type 0: Not a Combination Product12/14/2005
3NDC:65841-040-101000 in 1 BOTTLE; Type 0: Not a Combination Product12/14/2005
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA04059612/14/2005
PROMETHAZINE HYDROCHLORIDE 
promethazine hydrochloride tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-041
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PROMETHAZINE HYDROCHLORIDE (UNII: R61ZEH7I1I) (PROMETHAZINE - UNII:FF28EJQ494) PROMETHAZINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Score4 pieces
ShapeROUND (ROUND) Size8mm
FlavorImprint Code Z;C;0;2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-041-01100 in 1 BOTTLE; Type 0: Not a Combination Product12/14/2005
2NDC:65841-041-05500 in 1 BOTTLE; Type 0: Not a Combination Product12/14/2005
3NDC:65841-041-101000 in 1 BOTTLE; Type 0: Not a Combination Product12/14/2005
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA04059612/14/2005
PROMETHAZINE HYDROCHLORIDE 
promethazine hydrochloride tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-042
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PROMETHAZINE HYDROCHLORIDE (UNII: R61ZEH7I1I) (PROMETHAZINE - UNII:FF28EJQ494) PROMETHAZINE HYDROCHLORIDE50 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeROUND (ROUND) Size10mm
FlavorImprint Code ZC03
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-042-01100 in 1 BOTTLE; Type 0: Not a Combination Product12/14/2005
2NDC:65841-042-05500 in 1 BOTTLE; Type 0: Not a Combination Product12/14/2005
3NDC:65841-042-101000 in 1 BOTTLE; Type 0: Not a Combination Product12/14/2005
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA04059612/14/2005
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited677605858ANALYSIS(65841-040, 65841-041, 65841-042) , MANUFACTURE(65841-040, 65841-041, 65841-042)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(65841-040, 65841-041, 65841-042) , MANUFACTURE(65841-040, 65841-041, 65841-042)

Revised: 12/2024
Document Id: 800e2d40-d3af-43a0-9ea0-41e2d1d0e8b5
Set id: 4eaa8291-9cde-4205-857b-925ea8d618ba
Version: 7
Effective Time: 20241204
 
Zydus Lifesciences Limited