Amitriptyline Hydrochloride (Page 5 of 5)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label 1

AMITRIPTYLINE HYDROCHLORIDE
amitriptyline hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:80425-0362(NDC:29300-421)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLINE) AMITRIPTYLINE HYDROCHLORIDE 50 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
D&C YELLOW NO. 10
FD&C BLUE NO. 2–ALUMINUM LAKE
FD&C RED NO. 40
HYDROXYPROPYL CELLULOSE (110000 WAMW)
HYPROMELLOSE 2910 (6 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL 400
TITANIUM DIOXIDE
Product Characteristics
Color brown Score no score
Shape ROUND Size 8mm
Flavor Imprint Code U;421
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:80425-0362-1 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214548 10/20/2023
Labeler — Advanced Rx Pharmacy of Tennessee, LLC (117023142)
Establishment
Name Address ID/FEI Operations
Advanced Rx Pharmacy of Tennessee, LLC 117023142 repack (80425-0362)

Revised: 10/2023 Advanced Rx Pharmacy of Tennessee, LLC

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