NDC Code(s) : 0615-8386-39, 0615-8386-05
Packager : NCS HealthCare of KY, LLC dba Vangard Labs

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:0615-8386(NDC:50111-561)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRAZODONE HYDROCHLORIDE(UNII: 6E8ZO8LRNM)
(TRAZODONE - UNII:YBK48BXK30) 		TRAZODONE HYDROCHLORIDE100 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
Product Characteristics
Color white Score 2 pieces
Shape ROUND Size 12 mm
Flavor Imprint Code PLIVA;434
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0615-8386-3930 in 1 BLISTER PACK Type 0: Not a Combination Product02/10/2021
2NDC:0615-8386-0515 in 1 BLISTER PACK Type 0: Not a Combination Product02/10/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071524 10/08/2020

LABELER - NCS HealthCare of KY, LLC dba Vangard Labs(050052943)

Establishment
Name Address ID/FEI Business Operations
NCS HealthCare of KY, LLC dba Vangard Labs 050052943 repack(0615-8386)

PRINCIPAL DISPLAY PANEL

Trazodone 100mg bingo card label