NDC 68071-4720

AMITRIPTYLINE HYDROCHLORIDE

Amitriptyline Hydrochloride

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

Product ID68071-4720_7ffe0799-6457-b5e0-e053-2a91aa0ae06d
NDC68071-4720
Product TypeHuman Prescription Drug
Proprietary NameAMITRIPTYLINE HYDROCHLORIDE
Generic NameAmitriptyline Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2014-12-26
Marketing CategoryANDA / ANDA
Application NumberANDA202446
Labeler NameNuCare Pharmaceuticals,Inc.
Substance NameAMITRIPTYLINE HYDROCHLORIDE
Active Ingredient Strength75 mg/1
Pharm ClassesTricyclic Antidepressant [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68071-4720-3

30 TABLET, FILM COATED in 1 BOTTLE (68071-4720-3)
Marketing Start Date2019-01-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68071-4720-3 [68071472003]

AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202446
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-21

Drug Details

Active Ingredients

IngredientStrength
AMITRIPTYLINE HYDROCHLORIDE75 mg/1

OpenFDA Data

SPL SET ID:7ffe0799-6456-b5e0-e053-2a91aa0ae06d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 856853
  • UPC Code
  • 0368071472035
  • Pharmacological Class

    • Tricyclic Antidepressant [EPC]
    • 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.