Terbutaline Sulfate

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

Company

DUNS: 658871159

Effective Date

February 15, 2019

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Terbutaline(1 mg in 1 mL)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Labeler

UBI Pharma Inc.

DUNS Number

658871159

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

72843-101

Application Number

ANDA200122

Marketing Category

ANDA (C73584)

Route of Administration

SUBCUTANEOUS

Effective Date

February 15, 2019

Ingredients

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACT

Code: 576PU70Y8EClass: ACTIBQuantity: 1 mg in 1 mL