Label: OLOPATADINE HYDROCHLORIDE solution
- NDC Code(s): 72476-851-21
- Packager: Retail Business Services, LLC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated April 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)
NDC 72476-851-21
CAREone
Compare to the Active Ingredient in
Pataday® Once Daily Relief
EYE ALLERGY
ITCH RELIEF
Olopatadine Hydrochloride
Ophthalmic Solution USP, 0.2%
ONCE DAILY
Now available without a prescription
Antihistamine
Works in Minutes
Relief from Allergens:
Pet Dander, Pollen, Grass, Ragweed
STERILE
2.5 mL (0.085 FL OZ)
-
INGREDIENTS AND APPEARANCE
OLOPATADINE HYDROCHLORIDE
olopatadine hydrochloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72476-851 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:72476-851-21 1 in 1 CARTON 04/02/2021 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 04/02/2021 Labeler - Retail Business Services, LLC. (967989935) Registrant - Aurobindo Pharma Limited (650082092) Establishment Name Address ID/FEI Business Operations Aurobindo Pharma Limited 650498244 ANALYSIS(72476-851) , MANUFACTURE(72476-851)