NDC 0603-2213

Amitriptyline Hydrochloride

Amitriptyline Hydrochloride

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

Product ID0603-2213_00c58884-cf0f-47fb-8c0f-6d3e8ebc5c99
NDC0603-2213
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 NamePar Pharmaceutical
Substance NameAMITRIPTYLINE HYDROCHLORIDE
Active Ingredient Strength25 mg/1
Pharm ClassesTricyclic Antidepressant [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0603-2213-21

100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0603-2213-21)
Marketing Start Date1997-09-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0603-2213-30 [00603221330]

Amitriptyline Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA040218
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1997-09-11
Marketing End Date2018-06-30

NDC 0603-2213-20 [00603221320]

Amitriptyline Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA040218
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1997-09-11
Marketing End Date2014-06-11

NDC 0603-2213-16 [00603221316]

Amitriptyline Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA040218
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1997-09-11
Marketing End Date2014-06-11

NDC 0603-2213-21 [00603221321]

Amitriptyline Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA040218
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1997-09-11

NDC 0603-2213-32 [00603221332]

Amitriptyline Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA040218
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1997-09-11

NDC 0603-2213-02 [00603221302]

Amitriptyline Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA040218
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1997-09-11
Marketing End Date2018-03-31

Drug Details

Active Ingredients

IngredientStrength
AMITRIPTYLINE HYDROCHLORIDE25 mg/1

OpenFDA Data

SPL SET ID:f5c826ad-0d16-41e1-a499-d395f0aec2cd
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 856773
  • 856762
  • 856834
  • 856853
  • 856783
  • 856845
    • UPC Code
  • 0306032217219
  • 0306032215215
  • 0306032213211
  • 0306032214218
  • 0306032212214
  • 0306032216212

    • 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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