NDC 43598-265

Propofol Injectable Emulsion

Propofol Injectable Emulsion

Propofol Injectable Emulsion is a Intravenous Injection, Emulsion in the Human Prescription Drug category. It is labeled and distributed by Dr. Reddy's Laboratories, Inc.. The primary component is Propofol.

Product ID43598-265_31eb20bd-1546-77d7-327b-8fbb905f69b6
NDC43598-265
Product TypeHuman Prescription Drug
Proprietary NamePropofol Injectable Emulsion
Generic NamePropofol Injectable Emulsion
Dosage FormInjection, Emulsion
Route of AdministrationINTRAVENOUS
Marketing Start Date2018-11-15
Marketing CategoryANDA / ANDA
Application NumberANDA205067
Labeler NameDr. Reddy's Laboratories, Inc.
Substance NamePROPOFOL
Active Ingredient Strength10 mg/mL
Pharm ClassesGeneral Anesthesia [PE],General Anesthetic [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 43598-265-25

25 VIAL in 1 CARTON (43598-265-25) > 20 mL in 1 VIAL (43598-265-20)
Marketing Start Date2018-11-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43598-265-58 [43598026558]

Propofol Injectable Emulsion INJECTION, EMULSION
Marketing CategoryANDA
Application NumberANDA205067
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-11-15

NDC 43598-265-25 [43598026525]

Propofol Injectable Emulsion INJECTION, EMULSION
Marketing CategoryANDA
Application NumberANDA205067
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-11-15

NDC 43598-265-20 [43598026520]

Propofol Injectable Emulsion INJECTION, EMULSION
Marketing CategoryANDA
Application NumberANDA205067
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-11-15

Drug Details

Active Ingredients

IngredientStrength
PROPOFOL10 mg/mL

OpenFDA Data

SPL SET ID:800646b8-83a8-01d9-3dc8-bb2ddcb8570c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1808217
  • 1808224
  • 1808222
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Propofol Injectable Emulsion" or generic name "Propofol Injectable Emulsion"

    NDCBrand NameGeneric Name
    43598-265Propofol Injectable EmulsionPropofol Injectable Emulsion
    43598-548Propofol Injectable EmulsionPropofol Injectable Emulsion
    43598-549Propofol Injectable EmulsionPropofol Injectable Emulsion

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