PREGABALIN tablet, extended release

Pregabalin by

Drug Labeling and Warnings

Pregabalin 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: 70771-1739-3

Pregabalin extended-release tablets, 82.5 mg

Rx only

30 tablets

NDC: 70771-1740-3

Pregabalin extended-release tablets, 165 mg

Rx only

30 tablets

NDC: 70771-1741-3

Pregabalin extended-release tablets, 330 mg

Rx only

30 tablets

INGREDIENTS AND APPEARANCE

PREGABALIN 
pregabalin tablet, extended release

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1739
Route of Administration	ORAL	DEA Schedule	CV

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PREGABALIN (UNII: 55JG375S6M) (PREGABALIN - UNII:55JG375S6M)	PREGABALIN	82.5 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE (off-white)	Score	no score
Shape	OVAL	Size	17mm
Flavor		Imprint Code	779
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1739-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	04/12/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA215577	04/12/2025

PREGABALIN 
pregabalin tablet, extended release

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1740
Route of Administration	ORAL	DEA Schedule	CV

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PREGABALIN (UNII: 55JG375S6M) (PREGABALIN - UNII:55JG375S6M)	PREGABALIN	165 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	YELLOW (beige to yellow)	Score	no score
Shape	OVAL	Size	17mm
Flavor		Imprint Code	780
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1740-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	04/12/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA215577	04/12/2025

PREGABALIN 
pregabalin tablet, extended release

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1741
Route of Administration	ORAL	DEA Schedule	CV

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PREGABALIN (UNII: 55JG375S6M) (PREGABALIN - UNII:55JG375S6M)	PREGABALIN	330 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	PINK (light pink to pink)	Score	no score
Shape	OVAL	Size	22mm
Flavor		Imprint Code	781
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1741-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	04/12/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA215577	04/12/2025

Labeler - Zydus Lifesciences Limited (918596198)

Establishment
Name	Address	ID/FEI	Business Operations
Zydus Lifesciences Limited		863362789	ANALYSIS(70771-1739, 70771-1740, 70771-1741) , MANUFACTURE(70771-1739, 70771-1740, 70771-1741)