MedPath

Terbutaline Sulfate

TERBUTALINE SULFATE INJECTION, USP

Approved
Approval ID

6a22b62c-4ee1-49df-e053-2a91aa0a3e52

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 23, 2023

Manufacturers
FDA

Medical Purchasing Solutions. LLC

DUNS: 601458529

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 Code71872-7080
Application NumberANDA078630
Product Classification
M
Marketing Category
C73584
G
Generic Name
Terbutaline Sulfate
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateMay 23, 2023
FDA Product Classification

INGREDIENTS (4)

SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
TERBUTALINE SULFATEActive
Quantity: 1 mg in 1 mL
Code: 576PU70Y8E
Classification: ACTIB

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