Tobramycin

Manufacturing Establishments1

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

Labeler

Proficient Rx LP

DUNS Number

079196022

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

NDC Product Code

63187-973

Application Number

ANDA062535

Marketing Category

ANDA (C73584)

Route of Administration

OPHTHALMIC

Effective Date

December 1, 2018

Ingredients

BENZALKONIUM CHLORIDEInactive

Code: F5UM2KM3W7Class: IACT

Code: VZ8RRZ51VKClass: ACTIBQuantity: 3 mg in 1 mL

BORIC ACIDInactive

Code: R57ZHV85D4Class: IACT

SODIUM SULFATEInactive

Code: 0YPR65R21JClass: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACT

TYLOXAPOLInactive

Code: Y27PUL9H56Class: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

SULFURIC ACIDInactive

Code: O40UQP6WCFClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT