olopatadine hcl

Generic: olopatadine hcl

Labeler: sola pharmaceuticals
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name olopatadine hcl
Generic Name olopatadine hcl
Labeler sola pharmaceuticals
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

olopatadine hydrochloride 1 mg/mL

Manufacturer
Sola Pharmaceuticals

Identifiers & Regulatory

Product NDC 70512-520
Product ID 70512-520_45728450-eb13-7314-e063-6394a90ae6d1
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA203152
Listing Expiration 2026-12-31
Marketing Start 2022-07-05

Pharmacologic Class

Classes
decreased histamine release [pe] histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc] histamine-1 receptor inhibitor [epc] mast cell stabilizer [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70512520
Hyphenated Format 70512-520

Supplemental Identifiers

RxCUI
1111339
UPC
0705120520055
UNII
2XG66W44KF

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name olopatadine hcl (source: ndc)
Generic Name olopatadine hcl (source: ndc)
Application Number ANDA203152 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (70512-520-05) / 5 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

70512-520-05 1 BOTTLE, PLASTIC in 1 CARTON (70512-520-05) / 5 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

olopatadine hydrochloride (1 mg/mL)

Linked Drug Pages (1)

Olopatadine Hcl ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "45728450-eb13-7314-e063-6394a90ae6d1", "openfda": {"upc": ["0705120520055"], "unii": ["2XG66W44KF"], "rxcui": ["1111339"], "spl_set_id": ["e314e745-1e83-a530-e053-2995a90a67b4"], "manufacturer_name": ["Sola Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (70512-520-05)  / 5 mL in 1 BOTTLE, PLASTIC", "package_ndc": "70512-520-05", "marketing_start_date": "20220705"}], "brand_name": "Olopatadine Hcl", "product_id": "70512-520_45728450-eb13-7314-e063-6394a90ae6d1", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Decreased Histamine Release [PE]", "Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]", "Histamine-1 Receptor Inhibitor [EPC]", "Mast Cell Stabilizer [EPC]"], "product_ndc": "70512-520", "generic_name": "Olopatadine Hcl", "labeler_name": "Sola Pharmaceuticals", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Olopatadine Hcl", "active_ingredients": [{"name": "OLOPATADINE HYDROCHLORIDE", "strength": "1 mg/mL"}], "application_number": "ANDA203152", "marketing_category": "ANDA", "marketing_start_date": "20220705", "listing_expiration_date": "20261231"}