NDC 45865-648

Amitriptyline Hydrochloride

Amitriptyline Hydrochloride

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

Product ID45865-648_7205c0e2-d7fa-3451-e053-2a95a90a69b0
NDC45865-648
Product TypeHuman Prescription Drug
Proprietary NameAmitriptyline Hydrochloride
Generic NameAmitriptyline Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date1977-11-21
Marketing CategoryANDA / ANDA
Application NumberANDA085969
Labeler NameMedsource Pharmaceuticals
Substance NameAMITRIPTYLINE HYDROCHLORIDE
Active Ingredient Strength10 mg/1
Pharm ClassesTricyclic Antidepressant [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 45865-648-30

30 TABLET, FILM COATED in 1 BOTTLE (45865-648-30)
Marketing Start Date2018-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 45865-648-60 [45865064860]

Amitriptyline Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA085969
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-01-01

NDC 45865-648-30 [45865064830]

Amitriptyline Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA085969
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-01-01

NDC 45865-648-90 [45865064890]

Amitriptyline Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA085969
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-01-01

Drug Details

Active Ingredients

IngredientStrength
AMITRIPTYLINE HYDROCHLORIDE10 mg/1

OpenFDA Data

SPL SET ID:7205c0e2-d7f9-3451-e053-2a95a90a69b0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 856783

    • 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
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