Amitriptyline hydrochloride tablet, film coated

Ingredients and appearance - Product information

Amitriptyline hydrochloride tablet, film coated- Amitriptyline hydrochloride

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 63187-156
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Amitriptyline hydrochloride ( UNII: 26LUD4JO9K)( Amitriptyline - UNII: 1806D8D52K ) 50 mgin 1

Inactive Ingredients

Ingredient Name Code
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Hypromellose, unspecified ( UNII: 3NXW29V3WO)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Magnesium stearate ( UNII: 70097M6I30)
Microcrystalline cellulose ( UNII: OP1R32D61U)
Polyethylene glycol, unspecified ( 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) Size 8 mm
Shape ROUND Score 1
Imprint Code 2103;V

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA040218 USA

Labeler - Proficient Rx LP( 079196022)

Establishment

Name ID/FEI Business Operations
Proficient Rx LP 079196022 RELABEL( 63187-156), REPACK( 63187-156)