olopatadine hydrochloride

Generic: olopatadine hydrochloride

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name olopatadine hydrochloride
Generic Name olopatadine hydrochloride
Labeler rising pharma holdings, inc.
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

olopatadine hydrochloride 2 mg/mL

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 16571-861
Product ID 16571-861_d6814040-cbb9-4a23-aa29-e3d30bb97efc
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA204620
Listing Expiration 2026-12-31
Marketing Start 2025-05-01

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 16571861
Hyphenated Format 16571-861

Supplemental Identifiers

RxCUI
1111343
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 hydrochloride (source: ndc)
Generic Name olopatadine hydrochloride (source: ndc)
Application Number ANDA204620 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 1 CONTAINER in 1 CARTON (16571-861-25) / 2.5 mL in 1 CONTAINER
source: ndc

Packages (1)

16571-861-25 1 CONTAINER in 1 CARTON (16571-861-25) / 2.5 mL in 1 CONTAINER

Ingredients (1)

olopatadine hydrochloride (2 mg/mL)

Linked Drug Pages (1)

olopatadine hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "d6814040-cbb9-4a23-aa29-e3d30bb97efc", "openfda": {"unii": ["2XG66W44KF"], "rxcui": ["1111343"], "spl_set_id": ["0988e6e2-59a9-47dc-9386-9e9ea877e6c1"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 CONTAINER in 1 CARTON (16571-861-25)  / 2.5 mL in 1 CONTAINER", "package_ndc": "16571-861-25", "marketing_start_date": "20250501"}], "brand_name": "olopatadine hydrochloride", "product_id": "16571-861_d6814040-cbb9-4a23-aa29-e3d30bb97efc", "dosage_form": "SOLUTION", "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": "16571-861", "generic_name": "olopatadine hydrochloride", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "olopatadine hydrochloride", "active_ingredients": [{"name": "OLOPATADINE HYDROCHLORIDE", "strength": "2 mg/mL"}], "application_number": "ANDA204620", "marketing_category": "ANDA", "marketing_start_date": "20250501", "listing_expiration_date": "20261231"}