NDC 63323-665

Terbutaline Sulfate

Terbutaline Sulfate

Terbutaline Sulfate is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Terbutaline Sulfate.

Product ID63323-665_15846c75-dc60-4339-b97b-5c9d78d66cf1
NDC63323-665
Product TypeHuman Prescription Drug
Proprietary NameTerbutaline Sulfate
Generic NameTerbutaline Sulfate
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2011-03-10
Marketing CategoryANDA / ANDA
Application NumberANDA076887
Labeler NameFresenius Kabi USA, LLC
Substance NameTERBUTALINE SULFATE
Active Ingredient Strength1 mg/mL
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 63323-665-01

25 VIAL, SINGLE-USE in 1 TRAY (63323-665-01) > 1 mL in 1 VIAL, SINGLE-USE (63323-665-00)
Marketing Start Date2011-03-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63323-665-01 [63323066501]

Terbutaline Sulfate INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA076887
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2011-03-10

Drug Details

Active Ingredients

IngredientStrength
TERBUTALINE SULFATE1 mg/mL

OpenFDA Data

SPL SET ID:cec31032-f366-4524-9e01-63146e473b2b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 857635
  • NDC Crossover Matching brand name "Terbutaline Sulfate" or generic name "Terbutaline Sulfate"

    NDCBrand NameGeneric Name
    0115-2611TERBUTALINE SULFATETERBUTALINE SULFATE
    0115-2622TERBUTALINE SULFATETERBUTALINE SULFATE
    0143-9375Terbutaline SulfateTerbutaline Sulfate
    0143-9746Terbutaline SulfateTerbutaline Sulfate
    0404-9962Terbutaline SulfateTerbutaline Sulfate
    0527-1311Terbutaline SulfateTerbutaline Sulfate
    0527-1318Terbutaline SulfateTerbutaline Sulfate
    10135-579Terbutaline SulfateTerbutaline Sulfate
    10135-580Terbutaline SulfateTerbutaline Sulfate
    10271-101Terbutaline SulfateTerbutaline Sulfate
    17478-933Terbutaline SulfateTerbutaline Sulfate
    21695-121Terbutaline SulfateTerbutaline Sulfate
    21695-122Terbutaline SulfateTerbutaline Sulfate
    24979-132Terbutaline SulfateTerbutaline Sulfate
    24979-133Terbutaline SulfateTerbutaline Sulfate
    43063-558Terbutaline SulfateTerbutaline Sulfate
    52584-665Terbutaline SulfateTerbutaline Sulfate
    53808-0312Terbutaline SulfateTERBUTALINE SULFATE
    62559-721Terbutaline SulfateTerbutaline Sulfate
    62559-722Terbutaline SulfateTerbutaline Sulfate
    63323-665Terbutaline SulfateTERBUTALINE SULFATE
    67296-1053Terbutaline SulfateTerbutaline Sulfate
    70860-801Terbutaline Sulfateterbutaline sulfate
    71872-7130Terbutaline SulfateTerbutaline Sulfate
    71872-7080Terbutaline SulfateTerbutaline Sulfate
    72843-101Terbutaline SulfateTerbutaline Sulfate
    71205-938Terbutaline SulfateTerbutaline Sulfate
    71205-939Terbutaline SulfateTerbutaline Sulfate

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