Gentamicin Sulfate

Manufacturing Establishments1

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

Labeler

NuCare Pharmaceuticals,Inc.

DUNS Number

010632300

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

NDC Product Code

68071-3554

Application Number

ANDA064048

Marketing Category

ANDA (C73584)

Route of Administration

OPHTHALMIC

Effective Date

December 7, 2023

Ingredients

SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMInactive

Code: 3980JIH2SWClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACT

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

BENZALKONIUM CHLORIDEInactive

Code: F5UM2KM3W7Class: IACT

SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMInactive

Code: GR686LBA74Class: IACT

Code: 8X7386QRLVClass: ACTIMQuantity: 3 mg in 1 mL