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FDA Approval

Terbutaline Sulfate

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

FDA Approval Summary

Company
Chartwell RX, LLC.
DUNS: 079394054
Effective Date
March 2, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Terbutaline(2.5 mg in 1 1)

Manufacturing Establishments1

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

Lannett Company, Inc.

Chartwell RX, LLC.

006422406

Products2

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

Terbutaline Sulfate

Product Details

NDC Product Code
62135-524
Application Number
ANDA077152
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
March 2, 2023
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
TerbutalineActive
Code: 576PU70Y8EClass: ACTIBQuantity: 2.5 mg in 1 1

Terbutaline Sulfate

Product Details

NDC Product Code
62135-525
Application Number
ANDA077152
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
March 2, 2023
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TerbutalineActive
Code: 576PU70Y8EClass: ACTIBQuantity: 5 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
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