Tobramycin

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

68071-4537

Application Number

ANDA207444

Marketing Category

ANDA (C73584)

Route of Administration

OPHTHALMIC

Effective Date

February 19, 2021

Ingredients

BENZALKONIUM CHLORIDEInactive

Code: F5UM2KM3W7Class: IACT

BORIC ACIDInactive

Code: R57ZHV85D4Class: IACT

SODIUM SULFATE ANHYDROUSInactive

Code: 36KCS0R750Class: IACT

TYLOXAPOLInactive

Code: Y27PUL9H56Class: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

SULFURIC ACIDInactive

Code: O40UQP6WCFClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

Code: VZ8RRZ51VKClass: ACTIBQuantity: 3 mg in 1 mL