NDC Code(s) : 50090-4005-0, 50090-4005-4, 50090-4005-1, 50090-4005-8
Packager : A-S Medication Solutions

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Amitriptyline Hydrochloride Amitriptyline Hydrochloride TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-4005(NDC:70710-1226)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMITRIPTYLINE HYDROCHLORIDE(UNII: 26LUD4JO9K)
(AMITRIPTYLINE - UNII:1806D8D52K) 		AMITRIPTYLINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient Name Strength
ALUMINUM OXIDE(UNII: LMI26O6933)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL 8000(UNII: Q662QK8M3B)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STARCH, CORN(UNII: O8232NY3SJ)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color GREEN (LIGHT GREEN) Score no score
Shape ROUND (ROUND) Size 6 mm
Flavor Imprint Code ZA;2
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50090-4005-030 in 1 BOTTLE Type 0: Not a Combination Product27/12/2018
2NDC:50090-4005-460 in 1 BOTTLE Type 0: Not a Combination Product02/12/2019
3NDC:50090-4005-1100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product26/12/2017
4NDC:50090-4005-890 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product26/12/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210086 12/26/2017

LABELER - A-S Medication Solutions(830016429)

Establishment
Name Address ID/FEI Business Operations
A-S Medication Solutions 830016429 RELABEL(50090-4005), REPACK(50090-4005)

PRINCIPAL DISPLAY PANEL

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