ryaltris

Generic: olopatadine hydrochloride and mometasone furoate

Labeler: hikma specialty usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name ryaltris
Generic Name olopatadine hydrochloride and mometasone furoate
Labeler hikma specialty usa inc.
Dosage Form SPRAY, METERED
Routes
NASAL
Active Ingredients

mometasone furoate monohydrate 25 ug/1, olopatadine hydrochloride 665 ug/1

Manufacturer
HIKMA SPECIALTY USA INC.

Identifiers & Regulatory

Product NDC 59467-700
Product ID 59467-700_84bec5d6-00c3-45a3-ae2b-ec28c8b9a290
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA211746
Listing Expiration 2027-12-31
Marketing Start 2022-08-15

Pharmacologic Class

Classes
corticosteroid hormone receptor agonists [moa] corticosteroid [epc] 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 59467700
Hyphenated Format 59467-700

Supplemental Identifiers

RxCUI
2591806 2591812
UPC
0359467700276
UNII
MTW0WEG809 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 ryaltris (source: ndc)
Generic Name olopatadine hydrochloride and mometasone furoate (source: ndc)
Application Number NDA211746 (source: ndc)
Routes
NASAL
source: ndc

Resolved Composition

Strengths
  • 25 ug/1
  • 665 ug/1
source: ndc
Packaging
  • 12 CARTON in 1 BOX (59467-700-27) / 1 BOTTLE, SPRAY in 1 CARTON / 240 SPRAY, METERED in 1 BOTTLE, SPRAY
  • 12 CARTON in 1 BOX (59467-700-84) / 1 BOTTLE, SPRAY in 1 CARTON / 56 SPRAY, METERED in 1 BOTTLE, SPRAY
source: ndc

Packages (2)

59467-700-27 12 CARTON in 1 BOX (59467-700-27) / 1 BOTTLE, SPRAY in 1 CARTON / 240 SPRAY, METERED in 1 BOTTLE, SPRAY 59467-700-84 12 CARTON in 1 BOX (59467-700-84) / 1 BOTTLE, SPRAY in 1 CARTON / 56 SPRAY, METERED in 1 BOTTLE, SPRAY

Ingredients (2)

mometasone furoate monohydrate (25 ug/1) olopatadine hydrochloride (665 ug/1)

Linked Drug Pages (1)

Ryaltris ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["NASAL"], "spl_id": "84bec5d6-00c3-45a3-ae2b-ec28c8b9a290", "openfda": {"upc": ["0359467700276"], "unii": ["MTW0WEG809", "2XG66W44KF"], "rxcui": ["2591806", "2591812"], "spl_set_id": ["382eac74-a7ce-4f42-ac0a-b253308f335f"], "manufacturer_name": ["HIKMA SPECIALTY USA INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 CARTON in 1 BOX (59467-700-27)  / 1 BOTTLE, SPRAY in 1 CARTON / 240 SPRAY, METERED in 1 BOTTLE, SPRAY", "package_ndc": "59467-700-27", "marketing_start_date": "20220815"}, {"sample": false, "description": "12 CARTON in 1 BOX (59467-700-84)  / 1 BOTTLE, SPRAY in 1 CARTON / 56 SPRAY, METERED in 1 BOTTLE, SPRAY", "package_ndc": "59467-700-84", "marketing_start_date": "20220815"}], "brand_name": "Ryaltris", "product_id": "59467-700_84bec5d6-00c3-45a3-ae2b-ec28c8b9a290", "dosage_form": "SPRAY, METERED", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]", "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": "59467-700", "generic_name": "olopatadine hydrochloride and mometasone furoate", "labeler_name": "HIKMA SPECIALTY USA INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ryaltris", "active_ingredients": [{"name": "MOMETASONE FUROATE MONOHYDRATE", "strength": "25 ug/1"}, {"name": "OLOPATADINE HYDROCHLORIDE", "strength": "665 ug/1"}], "application_number": "NDA211746", "marketing_category": "NDA", "marketing_start_date": "20220815", "listing_expiration_date": "20271231"}