NDC 0527-1318

Terbutaline Sulfate

Terbutaline Sulfate

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

Product ID0527-1318_8455b6a5-b788-4ca4-af9d-be942f3c11c5
NDC0527-1318
Product TypeHuman Prescription Drug
Proprietary NameTerbutaline Sulfate
Generic NameTerbutaline Sulfate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2005-03-25
Marketing CategoryANDA / ANDA
Application NumberANDA077152
Labeler NameLannett Company, Inc.
Substance NameTERBUTALINE SULFATE
Active Ingredient Strength3 mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0527-1318-01

100 TABLET in 1 BOTTLE (0527-1318-01)
Marketing Start Date2005-03-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0527-1318-01 [00527131801]

Terbutaline Sulfate TABLET
Marketing CategoryANDA
Application NumberANDA077152
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-03-25

NDC 0527-1318-10 [00527131810]

Terbutaline Sulfate TABLET
Marketing CategoryANDA
Application NumberANDA077152
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-03-25

Drug Details

Active Ingredients

IngredientStrength
TERBUTALINE SULFATE2.5 mg/1

OpenFDA Data

SPL SET ID:fbf54709-5857-4dbc-9233-ebd7abff88c8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 857683
  • 857677
    • UPC Code
  • 0305271318015
  • 0305271311016

    • 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
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.