NDC Code(s) : 71205-568-30, 71205-568-60, 71205-568-90
Packager : Proficient Rx LP

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Trazodone HydrochlorideTrazodone Hydrochloride TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71205-568(NDC:50111-560)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRAZODONE HYDROCHLORIDE(UNII: 6E8ZO8LRNM)
(TRAZODONE - UNII:YBK48BXK30) 		TRAZODONE HYDROCHLORIDE50 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 10 mm
Flavor Imprint Code PLIVA;433
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:71205-568-3030 in 1 BOTTLE Type 0: Not a Combination Product17/05/2021
2NDC:71205-568-6060 in 1 BOTTLE Type 0: Not a Combination Product17/05/2021
3NDC:71205-568-9090 in 1 BOTTLE Type 0: Not a Combination Product17/05/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071523 10/01/2020

LABELER - Proficient Rx LP(079196022)

Establishment
Name Address ID/FEI Business Operations
Proficient Rx LP 079196022 REPACK(71205-568), RELABEL(71205-568)

PRINCIPAL DISPLAY PANEL

NDC 71205-568-90

TraZODONE Hydrochloride Tablets, USP

50 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Rx only

90 Tablets

71205-568-30