NDC 63187-978

Isoniazid

Isoniazid

Isoniazid is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Proficient Rx Lp. The primary component is Isoniazid.

Product ID63187-978_01182451-bbc1-423d-98c2-bfd1ba8039de
NDC63187-978
Product TypeHuman Prescription Drug
Proprietary NameIsoniazid
Generic NameIsoniazid
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1972-09-01
Marketing CategoryANDA / ANDA
Application NumberANDA080937
Labeler NameProficient Rx LP
Substance NameISONIAZID
Active Ingredient Strength300 mg/1
Pharm ClassesAntimycobacterial [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 63187-978-30

30 TABLET in 1 BOTTLE (63187-978-30)
Marketing Start Date2018-02-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63187-978-90 [63187097890]

Isoniazid TABLET
Marketing CategoryANDA
Application NumberANDA080937
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-02-01

NDC 63187-978-60 [63187097860]

Isoniazid TABLET
Marketing CategoryANDA
Application NumberANDA080937
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-02-01

NDC 63187-978-30 [63187097830]

Isoniazid TABLET
Marketing CategoryANDA
Application NumberANDA080937
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-02-01

Drug Details

Active Ingredients

IngredientStrength
ISONIAZID300 mg/1

OpenFDA Data

SPL SET ID:65e50989-d24c-4bb3-a041-d6aea2635ef1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197832
  • Pharmacological Class

    • Antimycobacterial [EPC]

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

    NDCBrand NameGeneric Name
    0143-1260IsoniazidIsoniazid
    0143-1261IsoniazidIsoniazid
    0185-4350IsoniazidIsoniazid
    0185-4351IsoniazidIsoniazid
    0440-1655IsoniazidIsoniazid
    0440-7655IsoniazidIsoniazid
    0527-1109IsoniazidIsoniazid
    0555-0066IsoniazidIsoniazid
    0555-0071IsoniazidIsoniazid
    0781-3056IsoniazidIsoniazid
    10135-584IsoniazidIsoniazid
    10544-087IsoniazidIsoniazid
    10544-121IsoniazidIsoniazid
    10544-218IsoniazidIsoniazid
    21695-627IsoniazidIsoniazid
    43063-463IsoniazidIsoniazid
    43063-709IsoniazidIsoniazid
    43063-710IsoniazidIsoniazid
    46287-009Isoniazidisoniazid
    46672-597isoniazidisoniazid
    46672-865isoniazidisoniazid
    46672-866isoniazidisoniazid
    50090-0370IsoniazidIsoniazid
    50090-0410IsoniazidIsoniazid
    50090-1490Isoniazidisoniazid
    68788-9116IsoniazidIsoniazid
    68788-8927IsoniazidIsoniazid
    68788-9405IsoniazidIsoniazid
    70518-0096IsoniazidIsoniazid
    70518-0595IsoniazidIsoniazid
    70518-1491IsoniazidIsoniazid
    71335-0275IsoniazidIsoniazid
    71610-108IsoniazidIsoniazid
    51079-083IsoniazidIsoniazid
    51655-391IsoniazidIsoniazid
    52959-145IsoniazidIsoniazid
    53002-2920IsoniazidIsoniazid
    53808-1041IsoniazidIsoniazid
    55289-055IsoniazidIsoniazid
    55695-031IsoniazidIsoniazid
    55695-027IsoniazidIsoniazid
    55695-033IsoniazidIsoniazid
    60687-158IsoniazidIsoniazid
    61748-013IsoniazidIsoniazid
    61748-016IsoniazidIsoniazid
    63187-978IsoniazidIsoniazid
    63629-3707IsoniazidIsoniazid
    66267-124IsoniazidIsoniazid
    67046-333IsoniazidIsoniazid

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