NDC 10135-580

Terbutaline Sulfate

Terbutaline Sulfate

Terbutaline Sulfate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Marlex Pharmaceuticals Inc. The primary component is Terbutaline Sulfate.

Product ID10135-580_500ad3da-ce1b-4289-acdd-be3ec36577fb
NDC10135-580
Product TypeHuman Prescription Drug
Proprietary NameTerbutaline Sulfate
Generic NameTerbutaline Sulfate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2014-10-01
Marketing CategoryANDA / ANDA
Application NumberANDA077152
Labeler NameMarlex Pharmaceuticals Inc
Substance NameTERBUTALINE SULFATE
Active Ingredient Strength5 mg/1
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 10135-580-01

100 TABLET in 1 BOTTLE (10135-580-01)
Marketing Start Date2014-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10135-580-32 [10135058032]

Terbutaline Sulfate TABLET
Marketing CategoryANDA
Application NumberANDA077152
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-10-01

NDC 10135-580-10 [10135058010]

Terbutaline Sulfate TABLET
Marketing CategoryANDA
Application NumberANDA077152
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-10-01

NDC 10135-580-01 [10135058001]

Terbutaline Sulfate TABLET
Marketing CategoryANDA
Application NumberANDA077152
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-10-01

Drug Details

Active Ingredients

IngredientStrength
TERBUTALINE SULFATE5 mg/1

OpenFDA Data

SPL SET ID:94742710-e87e-4e1c-85ee-0a2e7a77f0de
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 857683
  • 857677

    • 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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