NDC 68788-9013

Amitriptyline Hydrochloride

Amitriptyline Hydrochloride

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

Product ID68788-9013_c315a621-6d94-4cbf-b3ea-f823654e51ef
NDC68788-9013
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 NamePreferred Pharmaceuticals, Inc.
Substance NameAMITRIPTYLINE HYDROCHLORIDE
Active Ingredient Strength10 mg/1
Pharm ClassesTricyclic Antidepressant [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 68788-9013-9

90 TABLET, FILM COATED in 1 BOTTLE (68788-9013-9)
Marketing Start Date2011-06-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68788-9013-3 [68788901303]

Amitriptyline Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA085969
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-06-13
Marketing End Date2019-05-13

NDC 68788-9013-8 [68788901308]

Amitriptyline Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA085969
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-06-13
Marketing End Date2019-05-13

NDC 68788-9013-6 [68788901306]

Amitriptyline Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA085969
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-06-13
Marketing End Date2019-05-13

NDC 68788-9013-9 [68788901309]

Amitriptyline Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA085969
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-06-13
Marketing End Date2019-05-13

Drug Details

Active Ingredients

IngredientStrength
AMITRIPTYLINE HYDROCHLORIDE10 mg/1

OpenFDA Data

SPL SET ID:60e95c23-9070-4420-8ecb-a7a1ca8fe143
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 856783
  • 856762
  • 856834
  • 856845

    • 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.