SIMVASTATIN - simvastatin tablet, film coated 
Zydus Lifesciences Limited

----------

SIMVASTATIN TABLETS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-065-16 in bottle of 90 tablets

Simvastatin Tablets USP, 5 mg

Rx only

Simvastatin tablets 5 mg

NDC 65841-066-16 in bottle of 90 tablets

Simvastatin Tablets USP, 10 mg

Rx only

Simvastatin tablets 10 mg

NDC 65841-067-16 in bottle of 90 tablets

Simvastatin Tablets USP, 20 mg

Rx only

Simvastatin tablets 20 mg

NDC 65841-068-16 in bottle of 90 tablets

Simvastatin Tablets USP, 40 mg

Rx only

Simvastatin tablets 40 mg

NDC 65841-069-16 in bottle of 90 tablets

Simvastatin Tablets USP, 80 mg

Rx only

Simvastatin tablets 80 mg
SIMVASTATIN 
simvastatin tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-065
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SIMVASTATIN (UNII: AGG2FN16EV) (SIMVASTATIN - UNII:AGG2FN16EV) SIMVASTATIN5 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITE (WHITE) Scoreno score
ShapeOVAL (OVAL) Size9mm
FlavorImprint Code ZA19
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-065-0630 in 1 BOTTLE; Type 0: Not a Combination Product12/20/2006
2NDC:65841-065-1460 in 1 BOTTLE; Type 0: Not a Combination Product12/20/2006
3NDC:65841-065-1690 in 1 BOTTLE; Type 0: Not a Combination Product12/20/2006
4NDC:65841-065-05500 in 1 BOTTLE; Type 0: Not a Combination Product12/20/2006
5NDC:65841-065-101000 in 1 BOTTLE; Type 0: Not a Combination Product12/20/2006
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07783712/20/2006
SIMVASTATIN 
simvastatin tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-066
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SIMVASTATIN (UNII: AGG2FN16EV) (SIMVASTATIN - UNII:AGG2FN16EV) SIMVASTATIN10 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorPINK (PINK) Scoreno score
ShapeOVAL (OVAL) Size9mm
FlavorImprint Code ZA20
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-066-0630 in 1 BOTTLE; Type 0: Not a Combination Product12/20/2006
2NDC:65841-066-1460 in 1 BOTTLE; Type 0: Not a Combination Product12/20/2006
3NDC:65841-066-1690 in 1 BOTTLE; Type 0: Not a Combination Product12/20/2006
4NDC:65841-066-05500 in 1 BOTTLE; Type 0: Not a Combination Product12/20/2006
5NDC:65841-066-101000 in 1 BOTTLE; Type 0: Not a Combination Product12/20/2006
6NDC:65841-066-2410000 in 1 BOTTLE; Type 0: Not a Combination Product12/20/2006
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07783712/20/2006
SIMVASTATIN 
simvastatin tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-067
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SIMVASTATIN (UNII: AGG2FN16EV) (SIMVASTATIN - UNII:AGG2FN16EV) SIMVASTATIN20 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorBROWN (BROWN) Scoreno score
ShapeOVAL (OVAL) Size11mm
FlavorImprint Code ZA21
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-067-0630 in 1 BOTTLE; Type 0: Not a Combination Product12/20/2006
2NDC:65841-067-1460 in 1 BOTTLE; Type 0: Not a Combination Product12/20/2006
3NDC:65841-067-1690 in 1 BOTTLE; Type 0: Not a Combination Product12/20/2006
4NDC:65841-067-05500 in 1 BOTTLE; Type 0: Not a Combination Product12/20/2006
5NDC:65841-067-101000 in 1 BOTTLE; Type 0: Not a Combination Product12/20/2006
6NDC:65841-067-2410000 in 1 BOTTLE; Type 0: Not a Combination Product12/20/2006
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07783712/20/2006
SIMVASTATIN 
simvastatin tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-068
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SIMVASTATIN (UNII: AGG2FN16EV) (SIMVASTATIN - UNII:AGG2FN16EV) SIMVASTATIN40 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorPINK (PINK) Scoreno score
ShapeOVAL (OVAL) Size14mm
FlavorImprint Code ZA22
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-068-0630 in 1 BOTTLE; Type 0: Not a Combination Product12/20/2006
2NDC:65841-068-1460 in 1 BOTTLE; Type 0: Not a Combination Product12/20/2006
3NDC:65841-068-1690 in 1 BOTTLE; Type 0: Not a Combination Product12/20/2006
4NDC:65841-068-05500 in 1 BOTTLE; Type 0: Not a Combination Product12/20/2006
5NDC:65841-068-101000 in 1 BOTTLE; Type 0: Not a Combination Product12/20/2006
6NDC:65841-068-405000 in 1 BOTTLE; Type 0: Not a Combination Product12/20/2006
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07783712/20/2006
SIMVASTATIN 
simvastatin tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-069
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SIMVASTATIN (UNII: AGG2FN16EV) (SIMVASTATIN - UNII:AGG2FN16EV) SIMVASTATIN80 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeCAPSULE (CAPSULE) Size18mm
FlavorImprint Code ZA23
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-069-0630 in 1 BOTTLE; Type 0: Not a Combination Product12/20/2006
2NDC:65841-069-1460 in 1 BOTTLE; Type 0: Not a Combination Product12/20/2006
3NDC:65841-069-1690 in 1 BOTTLE; Type 0: Not a Combination Product12/20/2006
4NDC:65841-069-05500 in 1 BOTTLE; Type 0: Not a Combination Product12/20/2006
5NDC:65841-069-101000 in 1 BOTTLE; Type 0: Not a Combination Product12/20/2006
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07783712/20/2006
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(65841-065, 65841-066, 65841-067, 65841-068, 65841-069) , MANUFACTURE(65841-065, 65841-066, 65841-067, 65841-068, 65841-069)

Revised: 10/2022
Document Id: f6a1f948-fffb-40ff-a5fc-e6767c93957d
Set id: 881eb80b-712e-4aa2-bd23-290a3e5db6cd
Version: 12
Effective Time: 20221017
 
Zydus Lifesciences Limited