NDC 0463-6351

Amitriptyline Hydrochloride

Amitriptyline Hydrochloride

Amitriptyline Hydrochloride is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by C.o. Truxton, Inc.. The primary component is Amitriptyline Hydrochloride.

Product ID0463-6351_b66b20e0-3490-4e85-b626-b5c50d677c8f
NDC0463-6351
Product TypeHuman Prescription Drug
Proprietary NameAmitriptyline Hydrochloride
Generic NameAmitriptyline Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date1997-09-11
Marketing CategoryANDA / ANDA
Application NumberANDA040218
Labeler NameC.O. Truxton, Inc.
Substance NameAMITRIPTYLINE HYDROCHLORIDE
Active Ingredient Strength25 mg/1
Pharm ClassesTricyclic Antidepressant [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0463-6351-10

1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0463-6351-10)
Marketing Start Date1997-09-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0463-6351-10 [00463635110]

Amitriptyline Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA040218
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1997-09-11
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
AMITRIPTYLINE HYDROCHLORIDE25 mg/1

OpenFDA Data

SPL SET ID:9b3981cf-445b-4f34-a4e7-77376e098181
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 856845
  • 856762
  • 856834
  • Pharmacological Class

    • Tricyclic Antidepressant [EPC]

    NDC Crossover Matching brand name "Amitriptyline Hydrochloride" or generic name "Amitriptyline Hydrochloride"

    NDCBrand NameGeneric Name
    0378-2610Amitriptyline Hydrochlorideamitriptyline hydrochloride
    0378-2625Amitriptyline Hydrochlorideamitriptyline hydrochloride
    0378-2650Amitriptyline Hydrochlorideamitriptyline hydrochloride
    0378-2675Amitriptyline Hydrochlorideamitriptyline hydrochloride
    0378-2685Amitriptyline Hydrochlorideamitriptyline hydrochloride
    0378-2695Amitriptyline Hydrochlorideamitriptyline hydrochloride
    0463-6351Amitriptyline HydrochlorideAmitriptyline Hydrochloride
    0463-6352Amitriptyline HydrochlorideAmitriptyline Hydrochloride
    0463-6354Amitriptyline HydrochlorideAmitriptyline Hydrochloride
    0603-2212Amitriptyline HydrochlorideAmitriptyline Hydrochloride
    0603-2213Amitriptyline HydrochlorideAmitriptyline Hydrochloride
    0603-2214Amitriptyline HydrochlorideAmitriptyline Hydrochloride
    0603-2215Amitriptyline HydrochlorideAmitriptyline Hydrochloride
    0603-2216Amitriptyline HydrochlorideAmitriptyline Hydrochloride
    0603-2217Amitriptyline HydrochlorideAmitriptyline Hydrochloride
    0615-0828Amitriptyline HydrochlorideAmitriptyline Hydrochloride
    0615-0829Amitriptyline HydrochlorideAmitriptyline Hydrochloride
    0615-0830Amitriptyline HydrochlorideAmitriptyline Hydrochloride
    0781-1486Amitriptyline HydrochlorideAmitriptyline Hydrochloride
    0781-1487Amitriptyline HydrochlorideAmitriptyline Hydrochloride
    68071-1368AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE
    68071-1797AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE
    68071-3131AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE
    68071-4092AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE
    68071-4238Amitriptyline HydrochlorideAmitriptyline Hydrochloride
    68071-4108AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE
    68071-4104AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE
    68071-4348Amitriptyline HydrochlorideAmitriptyline Hydrochloride
    68071-4408AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE
    68071-4519Amitriptyline HydrochlorideAmitriptyline Hydrochloride
    68071-4662AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE
    68071-4405Amitriptyline HydrochlorideAmitriptyline Hydrochloride
    68071-4720AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE
    68151-2992Amitriptyline HydrochlorideAmitriptyline Hydrochloride
    68258-7160Amitriptyline HydrochlorideAmitriptyline Hydrochloride
    68788-2213Amitriptyline HydrochlorideAmitriptyline Hydrochloride
    68788-2212Amitriptyline HydrochlorideAmitriptyline Hydrochloride
    68788-6432AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE
    68788-6825AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE
    68788-6320AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE
    68788-0748Amitriptyline HydrochlorideAmitriptyline Hydrochloride
    68788-9015Amitriptyline HydrochlorideAmitriptyline Hydrochloride
    68788-6899AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE
    68788-7061AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE
    68788-9009Amitriptyline HydrochlorideAmitriptyline Hydrochloride
    68788-9014Amitriptyline HydrochlorideAmitriptyline Hydrochloride
    68788-9016Amitriptyline HydrochlorideAmitriptyline Hydrochloride
    68788-9013Amitriptyline HydrochlorideAmitriptyline Hydrochloride
    69158-002AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE
    69158-001AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.