PREGABALIN- pregabalin tablet, extended release 
Zydus Lifesciences Limited

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Pregabalin Extended-Release Tablets

SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1739-3

Pregabalin extended-release tablets, 82.5 mg

Rx only

30 tablets

82.5 mg label

NDC 70771-1740-3

Pregabalin extended-release tablets, 165 mg

Rx only

30 tablets

165 mg label

NDC 70771-1741-3

Pregabalin extended-release tablets, 330 mg

Rx only

30 tablets

330 mg label
PREGABALIN 
pregabalin tablet, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1739
Route of AdministrationORALDEA ScheduleCV    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PREGABALIN (UNII: 55JG375S6M) (PREGABALIN - UNII:55JG375S6M) PREGABALIN82.5 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSE 2208 (15000 MPA.S) (UNII: Z78RG6M2N2)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
HYDROXYPROPYL CELLULOSE (90000 WAMW) (UNII: UKE75GEA7F)  
CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)  
POLYETHYLENE GLYCOL 2000000 (UNII: 5K3991GVWI)  
POLYETHYLENE GLYCOL 7000000 (UNII: G3MS6M810Y)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
Product Characteristics
ColorWHITE (off-white) Scoreno score
ShapeOVALSize17mm
FlavorImprint Code 779
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1739-330 in 1 BOTTLE; Type 0: Not a Combination Product04/12/202505/01/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21557704/12/202505/05/2025
PREGABALIN 
pregabalin tablet, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1740
Route of AdministrationORALDEA ScheduleCV    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PREGABALIN (UNII: 55JG375S6M) (PREGABALIN - UNII:55JG375S6M) PREGABALIN165 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSE 2208 (15000 MPA.S) (UNII: Z78RG6M2N2)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
HYDROXYPROPYL CELLULOSE (90000 WAMW) (UNII: UKE75GEA7F)  
CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)  
POLYETHYLENE GLYCOL 2000000 (UNII: 5K3991GVWI)  
POLYETHYLENE GLYCOL 7000000 (UNII: G3MS6M810Y)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Product Characteristics
ColorYELLOW (beige to yellow) Scoreno score
ShapeOVALSize17mm
FlavorImprint Code 780
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1740-330 in 1 BOTTLE; Type 0: Not a Combination Product04/12/202505/01/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21557704/12/202505/05/2025
PREGABALIN 
pregabalin tablet, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1741
Route of AdministrationORALDEA ScheduleCV    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PREGABALIN (UNII: 55JG375S6M) (PREGABALIN - UNII:55JG375S6M) PREGABALIN330 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSE 2208 (15000 MPA.S) (UNII: Z78RG6M2N2)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
HYDROXYPROPYL CELLULOSE (90000 WAMW) (UNII: UKE75GEA7F)  
CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)  
POLYETHYLENE GLYCOL 2000000 (UNII: 5K3991GVWI)  
POLYETHYLENE GLYCOL 7000000 (UNII: G3MS6M810Y)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
Product Characteristics
ColorPINK (light pink to pink) Scoreno score
ShapeOVALSize22mm
FlavorImprint Code 781
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1741-330 in 1 BOTTLE; Type 0: Not a Combination Product04/12/202505/01/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21557704/12/202505/05/2025
Labeler - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited863362789ANALYSIS(70771-1739, 70771-1740, 70771-1741) , MANUFACTURE(70771-1739, 70771-1740, 70771-1741)

Revised: 5/2025
Document Id: 1d1c19fc-2856-4353-88c7-1eaf3241d664
Set id: 1feb2f87-1751-4376-a8bb-a311cebd05d7
Version: 4
Effective Time: 20250505
 
Zydus Lifesciences Limited