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FDA Approval

Nafcillin

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

FDA Approval Summary

Company
Effective Date
May 17, 2019
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Nafcillin(1 g in 4 mL)

Manufacturing Establishments1

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

Istituto Biochimico Italiano G. Lorenzini S.p.A.

Fresenius Kabi USA, LLC

432432581

Products2

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

Nafcillin

Product Details

NDC Product Code
63323-327
Application Number
ANDA090002
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS, INTRAMUSCULAR
Effective Date
May 17, 2019
SODIUM CITRATEInactive
Code: 1Q73Q2JULRClass: IACTQuantity: 40 mg in 4 mL
NafcillinActive
Code: 49G3001BCKClass: ACTIMQuantity: 1 g in 4 mL

Nafcillin

Product Details

NDC Product Code
63323-328
Application Number
ANDA090002
Marketing Category
ANDA (C73584)
Route of Administration
INTRAMUSCULAR, INTRAVENOUS
Effective Date
May 17, 2019
SODIUM CITRATEInactive
Code: 1Q73Q2JULRClass: IACTQuantity: 40 mg in 8 mL
NafcillinActive
Code: 49G3001BCKClass: ACTIMQuantity: 2 g in 8 mL
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