Terbutaline Sulfate
TERBUTALINE SULFATE INJECTION USP
Approved
Approval ID
81e7751e-4e44-d529-e053-2a91aa0a7646
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 15, 2019
Manufacturers
FDA
UBI Pharma Inc.
DUNS: 658871159
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 Code72843-101
Application NumberANDA200122
Product Classification
M
Marketing Category
C73584
G
Generic Name
Terbutaline Sulfate
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateFebruary 15, 2019
FDA Product Classification
INGREDIENTS (3)
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
TERBUTALINE SULFATEActive
Quantity: 1 mg in 1 mL
Code: 576PU70Y8E
Classification: ACTIB