NDC 55289-055

Isoniazid

Isoniazid

Isoniazid is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Pd-rx Pharmaceuticals, Inc.. The primary component is Isoniazid.

Product ID55289-055_7bad325a-4d73-a0a7-e053-2a91aa0ad96b
NDC55289-055
Product TypeHuman Prescription Drug
Proprietary NameIsoniazid
Generic NameIsoniazid
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1972-02-28
Marketing CategoryANDA / ANDA
Application NumberANDA080212
Labeler NamePD-Rx Pharmaceuticals, Inc.
Substance NameISONIAZID
Active Ingredient Strength100 mg/1
Pharm ClassesAntimycobacterial [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 55289-055-60

60 TABLET in 1 BOTTLE, PLASTIC (55289-055-60)
Marketing Start Date2011-07-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55289-055-01 [55289005501]

Isoniazid TABLET
Marketing CategoryANDA
Application NumberANDA080212
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-07-11
Marketing End Date2019-09-09

NDC 55289-055-30 [55289005530]

Isoniazid TABLET
Marketing CategoryANDA
Application NumberANDA080212
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-07-11
Marketing End Date2019-09-09

NDC 55289-055-60 [55289005560]

Isoniazid TABLET
Marketing CategoryANDA
Application NumberANDA080212
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-07-11
Marketing End Date2019-09-09

NDC 55289-055-75 [55289005575]

Isoniazid TABLET
Marketing CategoryANDA
Application NumberANDA080212
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-07-11
Marketing End Date2019-09-09

NDC 55289-055-45 [55289005545]

Isoniazid TABLET
Marketing CategoryANDA
Application NumberANDA080212
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-07-11
Marketing End Date2019-09-09

Drug Details

Active Ingredients

IngredientStrength
ISONIAZID100 mg/1

OpenFDA Data

SPL SET ID:5aa596d6-2a56-4cd3-8318-3ca54711be13
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311166
  • UPC Code
  • 0355289055303
  • 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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