Terbutaline Sulfate
Terbutaline Sulfate Injection, USP 1mg/mL 1mL single dose vial
Approved
Approval ID
9f4b177e-4d7d-4255-afeb-522c7d4594c6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 22, 2023
Manufacturers
FDA
Henry Schein, Inc.
DUNS: 012430880
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Terbutaline Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0404-9962
Application NumberANDA076887
Product Classification
M
Marketing Category
C73584
G
Generic Name
Terbutaline Sulfate
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJanuary 12, 2022
FDA Product Classification
INGREDIENTS (1)
Terbutaline SulfateActive
Quantity: 1 mg in 1 mL
Code: 576PU70Y8E
Classification: ACTIB