NDC 12164-012

Isoflurane

Isoflurane

Isoflurane is a Respiratory (inhalation) Liquid in the Human Prescription Drug category. It is labeled and distributed by Halocarbon Products Corp.. The primary component is Isoflurane.

Product ID12164-012_2b04a0c7-b189-4355-a481-0b6f32050222
NDC12164-012
Product TypeHuman Prescription Drug
Proprietary NameIsoflurane
Generic NameIsoflurane
Dosage FormLiquid
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date1999-10-20
Marketing CategoryANDA / ANDA
Application NumberANDA075225
Labeler NameHalocarbon Products Corp.
Substance NameISOFLURANE
Active Ingredient Strength1 mL/mL
Pharm ClassesGeneral Anesthesia [PE],General Anesthetic [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 12164-012-10

100 mL in 1 BOTTLE, GLASS (12164-012-10)
Marketing Start Date1999-10-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 12164-012-25 [12164001225]

Isoflurane LIQUID
Marketing CategoryANDA
Application NumberANDA075225
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1999-10-20
Inactivation Date2020-01-31
Reactivation Date2020-04-20

NDC 12164-012-10 [12164001210]

Isoflurane LIQUID
Marketing CategoryANDA
Application NumberANDA075225
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1999-10-20
Inactivation Date2020-01-31
Reactivation Date2020-04-20

Drug Details

Active Ingredients

IngredientStrength
ISOFLURANE1 mL/mL

OpenFDA Data

SPL SET ID:e8e57cd7-b662-4e1c-beda-e73a4b3d16ae
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 542347
  • UPC Code
  • 0312164012257
  • Pharmacological Class

    • General Anesthesia [PE]
    • General Anesthetic [EPC]

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

    NDCBrand NameGeneric Name
    12164-012IsofluraneIsoflurane
    66794-017IsofluraneIsoflurane
    66794-020IsofluraneIsoflurane
    10019-360FORANEisoflurane
    66794-011TerrellIsoflurane
    66794-019TerrellIsoflurane

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