retaine allergy

Generic: olopatadine hydrochloride

Labeler: ocusoft inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name retaine allergy
Generic Name olopatadine hydrochloride
Labeler ocusoft inc.
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

olopatadine hydrochloride 5 mg/2.5mL

Manufacturer
OCuSOFT INC.

Identifiers & Regulatory

Product NDC 54799-920
Product ID 54799-920_8f87d85b-1ff7-45dd-9859-f9878e691fe1
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA209420
Listing Expiration 2027-12-31
Marketing Start 2024-07-05

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 54799920
Hyphenated Format 54799-920

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 retaine allergy (source: ndc)
Generic Name olopatadine hydrochloride (source: ndc)
Application Number ANDA209420 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/2.5mL
source: ndc
Packaging
  • 2.5 mL in 1 BOTTLE, PLASTIC (54799-920-25)
source: ndc

Packages (1)

54799-920-25 2.5 mL in 1 BOTTLE, PLASTIC (54799-920-25)

Ingredients (1)

olopatadine hydrochloride (5 mg/2.5mL)

Linked Drug Pages (1)

Retaine Allergy ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "8f87d85b-1ff7-45dd-9859-f9878e691fe1", "openfda": {"unii": ["2XG66W44KF"], "rxcui": ["1111343"], "spl_set_id": ["e0a01606-275d-448c-8838-ca46f1e612e5"], "manufacturer_name": ["OCuSOFT INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2.5 mL in 1 BOTTLE, PLASTIC (54799-920-25)", "package_ndc": "54799-920-25", "marketing_start_date": "20240705"}], "brand_name": "Retaine Allergy", "product_id": "54799-920_8f87d85b-1ff7-45dd-9859-f9878e691fe1", "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": "54799-920", "generic_name": "olopatadine hydrochloride", "labeler_name": "OCuSOFT INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Retaine Allergy", "active_ingredients": [{"name": "OLOPATADINE HYDROCHLORIDE", "strength": "5 mg/2.5mL"}], "application_number": "ANDA209420", "marketing_category": "ANDA", "marketing_start_date": "20240705", "listing_expiration_date": "20271231"}