OLOPATADINE HYDROCHLORIDE

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

68071-5085

Application Number

ANDA206306

Marketing Category

ANDA (C73584)

Route of Administration

OPHTHALMIC

Effective Date

February 19, 2021

Ingredients

BENZALKONIUM CHLORIDEInactive

Code: F5UM2KM3W7Class: IACTQuantity: 0.1 mg in 1 mL

SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive

Code: 22ADO53M6FClass: IACTQuantity: 5 mg in 1 mL

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACTQuantity: 6.5 mg in 1 mL

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

Code: 2XG66W44KFClass: ACTIMQuantity: 1.11 mg in 1 mL

WATERInactive

Code: 059QF0KO0RClass: IACT