OLOPATADINE HYDROCHLORIDE

Product NDC
68001-530
11-digit product format
680010530
Labeler code
68001
Product ID
68001-530_dbd299b7-11c8-bf59-e053-2a95a90a2cd4
Type
HUMAN OTC DRUG
Nonproprietary name
OLOPATADINE HYDROCHLORIDE
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
BluePoint Laboratories
Application
ANDA209995
Marketing category
ANDA
Marketing start
2022-04-08
Substance
OLOPATADINE HYDROCHLORIDE
Active strength
2 mg/mL
Pharmacologic classes
Decreased Histamine Release [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Histamine-1 Receptor Inhibitor [EPC], Mast Cell Stabilizer [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
2XG66W44KFOLOPATADINE HYDROCHLORIDE140462-76-6OLOPATADINE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68001-530-69680010530691 BOTTLE, PLASTIC in 1 CARTON (68001-530-69) / 2.5 mL in 1 BOTTLE, PLASTIC2022-04-08NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Olopatadine Hydrochloride Ophthalmic Solution, USP 0.2%BluePoint Laboratories | Eugia Pharma Specialities Limited2022-04-08HUMAN OTC DRUG LABEL1