NDC Code(s) : 55154-5764-9, 55154-5764-3, 55154-5765-9, 55154-5765-3, 55154-5762-0, 55154-5762-6, 55154-5762-4
Packager : Cardinal Health

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:55154-5764(NDC:50111-433)
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 9 mm
Flavor Imprint Code PLIVA;433
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55154-5764-930 in 1 BLISTER PACK Type 0: Not a Combination Product30/09/1990
2NDC:55154-5764-328 in 1 BLISTER PACK Type 0: Not a Combination Product30/09/1990
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071523 09/30/1990 12/15/2015
Trazodone HydrochlorideTrazodone Hydrochloride TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-5765(NDC:50111-434)
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)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 11 mm
Flavor Imprint Code PLIVA;434
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55154-5765-930 in 1 BLISTER PACK Type 0: Not a Combination Product30/09/1990
2NDC:55154-5765-328 in 1 BLISTER PACK Type 0: Not a Combination Product30/09/1990
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071524 09/30/1990 12/15/2015
Trazodone HydrochlorideTrazodone Hydrochloride TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-5762(NDC:50111-441)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRAZODONE HYDROCHLORIDE(UNII: 6E8ZO8LRNM)
(TRAZODONE - UNII:YBK48BXK30) 		TRAZODONE HYDROCHLORIDE150 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 3 pieces
Shape TRAPEZOID Size 17 mm
Flavor Imprint Code PLIVA;441;50;50;50
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55154-5762-010 in 1 BAG 30/09/1990
11 in 1 POUCH Type 0: Not a Combination Product
2NDC:55154-5762-4100 in 1 CARTON 30/09/1990
2NDC:55154-5762-61 in 1 POUCH Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071525 09/30/1990 12/31/2013

PRINCIPAL DISPLAY PANEL

Trazodone Hydrochloride Tablets USP

150 mg

10 Tablets

bag label

PRINCIPAL DISPLAY PANEL

Trazodone Hydrochloride Tablet, USP

150 mg

pouch

PRINCIPAL DISPLAY PANEL

Trazodone Hydrochloride Tablets, USP

150 mg

100 Tablets

carton label

PRINCIPAL DISPLAY PANEL

Trazodone Hydrochloride Tablets, USP

50 mg

card label

PRINCIPAL DISPLAY PANEL

Trazodone Hydrochloride Tablets, USP

50 mg

28 Tablets

lidding label

PRINCIPAL DISPLAY PANEL

Trazodone Hydrochloride Tablets, USP

50 mg

card label

PRINCIPAL DISPLAY PANEL

Trazodone Hydrochloride Tablets, USP

50 mg

30 Tablets

bingo label

PRINCIPAL DISPLAY PANEL

Trazodone Hydrochloride

100 mg

tablets USP

card label

PRINCIPAL DISPLAY PANEL

Trazodone Hydrochloride Tablets, USP

100 mg

28 Tablets

lidding label

PRINCIPAL DISPLAY PANEL

Trazodone Hydrochloride

100 mg

tablets USP

card label

PRINCIPAL DISPLAY PANEL

Trazodone Hydrochloride Tablets, USP

100 mg

30 Tablets

bingo label