NDC Code(s) : 58118-2214-9, 58118-2214-3, 58118-2214-8, 58118-2214-0
Packager : Clinical Solutions Wholesale

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Amitriptyline HydrochlorideAmitriptyline Hydrochloride TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58118-2214(NDC:0603-2214)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMITRIPTYLINE HYDROCHLORIDE(UNII: 26LUD4JO9K)
(AMITRIPTYLINE - UNII:1806D8D52K) 		AMITRIPTYLINE HYDROCHLORIDE50 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
HYPROMELLOSES(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color brown (beige) Score no score
Shape ROUND Size 8 mm
Flavor Imprint Code 2103;V
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58118-2214-990 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product11/09/1997
2NDC:58118-2214-330 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product11/09/1997
3NDC:58118-2214-830 in 1 BLISTER PACK Type 0: Not a Combination Product11/09/1997
4NDC:58118-2214-01 in 1 PACKET Type 0: Not a Combination Product11/09/1997
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040218 09/11/1997 06/15/2017

PRINCIPAL DISPLAY PANEL

Amitriptyline 50mg PacketAmitriptyline 50mg PacketAmitriptyline 50mg PacketAmitriptyline 50mg Packet