NDC Code(s) : 71205-639-30, 71205-639-60, 71205-639-90
Packager : Proficient Rx LP

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CV

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

PregabalinPregabalin CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71205-639(NDC:67877-465)
Route of Administration ORAL DEA Schedule CV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PREGABALIN(UNII: 55JG375S6M)
(PREGABALIN - UNII:55JG375S6M) 		PREGABALIN100 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
TALC(UNII: 7SEV7J4R1U)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERRIC OXIDE RED(UNII: 1K09F3G675)
SHELLAC(UNII: 46N107B71O)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
Product Characteristics
Color ORANGE Score no score
Shape CAPSULE Size 16 mm
Flavor Imprint Code A010;PREG100
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:71205-639-3030 in 1 BOTTLE Type 0: Not a Combination Product14/02/2022
2NDC:71205-639-6060 in 1 BOTTLE Type 0: Not a Combination Product14/02/2022
3NDC:71205-639-9090 in 1 BOTTLE Type 0: Not a Combination Product14/02/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207799 07/21/2019

LABELER - Proficient Rx LP(079196022)

Establishment
Name Address ID/FEI Business Operations
Proficient Rx LP 079196022 REPACK(71205-639), RELABEL(71205-639)

PRINCIPAL DISPLAY PANEL

NDC 71205-639-30
Pregabalin Capsules 100 mg
Rx only
30 Capsules

71205-639-30