LYRICA (Page 8 of 8)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

505
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LYRICA lyrica capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61919-505(NDC:0071-1015)
Route of Administration ORAL DEA Schedule CV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PREGABALIN (PREGABALIN) PREGABALIN 100 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
STARCH, CORN
TALC
GELATIN
TITANIUM DIOXIDE
FERRIC OXIDE RED
SHELLAC
FERROSOFERRIC OXIDE
PROPYLENE GLYCOL
POTASSIUM HYDROXIDE
Product Characteristics
Color orange Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code Pfizer;PGN;100
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61919-505-30 30 CAPSULE in 1 BOTTLE None
2 NDC:61919-505-60 60 CAPSULE in 1 BOTTLE None
3 NDC:61919-505-90 90 CAPSULE in 1 PACKAGE None
4 NDC:61919-505-72 120 CAPSULE in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021446 01/01/2015
Labeler — DirectRX (079254320)
Establishment
Name Address ID/FEI Operations
DirectRX 079254320 repack (61919-505)

Revised: 01/2020 DirectRX

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