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FDA Approval

PENICILLIN G POTASSIUM

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

FDA Approval Summary

Company

Baxter Healthcare Corporation

DUNS: 005083209

Effective Date

May 13, 2021

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Potassium(1000000 [iU] in 50 mL)

Manufacturing Establishments1

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

Baxter Healthcare Corporation

Labeler

Baxter Healthcare Corporation

DUNS Number

194684502

Products3

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

PENICILLIN G POTASSIUM

Product Details

NDC Product Code

0338-1021

Application Number

NDA050638

Marketing Category

NDA (C73594)

Route of Administration

INTRAVENOUS

Effective Date

July 18, 2016

Ingredients

PotassiumActive

Code: VL775ZTH4CClass: ACTIMQuantity: 1000000 [iU] in 50 mL

DEXTROSE MONOHYDRATEInactive

Code: LX22YL083GClass: IACTQuantity: 2 g in 50 mL

TRISODIUM CITRATE DIHYDRATEInactive

Code: B22547B95KClass: IACTQuantity: 100 mg in 50 mL

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

PENICILLIN G POTASSIUM

Product Details

NDC Product Code

0338-1023

Application Number

NDA050638

Marketing Category

NDA (C73594)

Route of Administration

INTRAVENOUS

Effective Date

July 18, 2016

Ingredients

TRISODIUM CITRATE DIHYDRATEInactive

Code: B22547B95KClass: IACTQuantity: 200 mg in 50 mL

DEXTROSE MONOHYDRATEInactive

Code: LX22YL083GClass: IACTQuantity: 1.2 g in 50 mL

PotassiumActive

Code: VL775ZTH4CClass: ACTIMQuantity: 2000000 [iU] in 50 mL

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

PENICILLIN G POTASSIUM

Product Details

NDC Product Code

0338-1025

Application Number

NDA050638

Marketing Category

NDA (C73594)

Route of Administration

INTRAVENOUS

Effective Date

July 18, 2016

Ingredients

PotassiumActive

Code: VL775ZTH4CClass: ACTIMQuantity: 3000000 [iU] in 50 mL

DEXTROSE MONOHYDRATEInactive

Code: LX22YL083GClass: IACTQuantity: 350 mg in 50 mL

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

TRISODIUM CITRATE DIHYDRATEInactive

Code: B22547B95KClass: IACTQuantity: 300 mg in 50 mL

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