NDC 0781-5578

Entacapone

Entacapone

Entacapone is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Sandoz Inc. The primary component is Entacapone.

Product ID0781-5578_b5bbb386-1430-4283-934d-d4bdf4268c65
NDC0781-5578
Product TypeHuman Prescription Drug
Proprietary NameEntacapone
Generic NameEntacapone
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2014-06-04
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA020796
Labeler NameSandoz Inc
Substance NameENTACAPONE
Active Ingredient Strength200 mg/1
Pharm ClassesCatechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0781-5578-01

100 TABLET, FILM COATED in 1 BOTTLE (0781-5578-01)
Marketing Start Date2014-06-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0781-5578-01 [00781557801]

Entacapone TABLET, FILM COATED
Marketing CategoryNDA authorized generic
Application NumberNDA020796
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-06-04

Drug Details

Active Ingredients

IngredientStrength
ENTACAPONE200 mg/1

OpenFDA Data

SPL SET ID:ad4b6d79-efd3-4c43-b4dc-5afdacf939a4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 317094

    • Pharmacological Class

    • Catechol O-Methyltransferase Inhibitors [MoA]
    • Catechol-O-Methyltransferase Inhibitor [EPC]

    NDC Crossover Matching brand name "Entacapone" or generic name "Entacapone"

    NDCBrand NameGeneric Name
    0378-9080EntacaponeEntacapone
    0527-1830Entacaponeentacapone
    0615-8298EntacaponeEntacapone
    0781-5578EntacaponeEntacapone
    0904-6822EntacaponeEntacapone
    27241-049EntacaponeEntacapone
    33342-260EntacaponeEntacapone
    43353-996EntacaponeEntacapone
    46708-478ENTACAPONEENTACAPONE
    47335-007EntacaponeEntacapone
    48792-7830Entacaponeentacapone
    50268-295EntacaponeEntacapone
    51079-273EntacaponeEntacapone
    55648-290EntacaponeEntacapone
    55648-711EntacaponeEntacapone
    55648-781EntacaponeEntacapone
    60687-188EntacaponeEntacapone
    62332-478ENTACAPONEENTACAPONE
    64679-290EntacaponeEntacapone
    64679-711EntacaponeEntacapone
    64679-781EntacaponeEntacapone
    71610-247EntacaponeEntacapone
    65862-654EntacaponeEntacapone
    0078-0327Comtanentacapone
    52427-800Comtanentacapone
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