Label: OLOPATADINE HYDROCHLORIDE solution
- NDC Code(s): 80539-001-39
- Packager: Allwell Health Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated March 1, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Purpose
- Use
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor if you experience:
- Keep out of reach of children.
- Directions
- Other information
- Inactive ingredients
- Questions?
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.2% (2.5 mL Container)
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.2% (2.5 mL Container Carton)
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INGREDIENTS AND APPEARANCE
OLOPATADINE HYDROCHLORIDE
olopatadine hydrochloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80539-001 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OLOPATADINE HYDROCHLORIDE (UNII: 2XG66W44KF) (OLOPATADINE - UNII:D27V6190PM) OLOPATADINE HYDROCHLORIDE 2 mg in 1 mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74) EDETATE DISODIUM (UNII: 7FLD91C86K) HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SODIUM CHLORIDE (UNII: 451W47IQ8X) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80539-001-39 1 in 1 CARTON 07/15/2020 1 2.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA209995 07/15/2020 Labeler - Allwell Health Inc (117644800) Registrant - Aurobindo Pharma Limited (650082092) Establishment Name Address ID/FEI Business Operations Aurobindo Pharma Limited 650498244 ANALYSIS(80539-001) , MANUFACTURE(80539-001)