topcare allergy

Generic: mometasone furoate monohydrate

Labeler: topco associates llc
NDC Directory HUMAN OTC DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name topcare allergy
Generic Name mometasone furoate monohydrate
Labeler topco associates llc
Dosage Form SPRAY, METERED
Routes
NASAL
Active Ingredients

mometasone furoate monohydrate 50 ug/1

Manufacturer
Topco Associates LLC

Identifiers & Regulatory

Product NDC 76162-134
Product ID 76162-134_1396fed3-16fb-421a-89c5-4dd83706cd41
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA215712
Listing Expiration 2026-12-31
Marketing Start 2023-03-28

Pharmacologic Class

Classes
corticosteroid hormone receptor agonists [moa] corticosteroid [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76162134
Hyphenated Format 76162-134

Supplemental Identifiers

RxCUI
1797865
UNII
MTW0WEG809

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 topcare allergy (source: ndc)
Generic Name mometasone furoate monohydrate (source: ndc)
Application Number NDA215712 (source: ndc)
Routes
NASAL
source: ndc

Resolved Composition

Strengths
  • 50 ug/1
source: ndc
Packaging
  • 1 BOTTLE, SPRAY in 1 CARTON (76162-134-02) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY
  • 1 BOTTLE, SPRAY in 1 CARTON (76162-134-11) / 60 SPRAY, METERED in 1 BOTTLE, SPRAY
source: ndc

Packages (2)

76162-134-02 1 BOTTLE, SPRAY in 1 CARTON (76162-134-02) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY 76162-134-11 1 BOTTLE, SPRAY in 1 CARTON (76162-134-11) / 60 SPRAY, METERED in 1 BOTTLE, SPRAY

Ingredients (1)

mometasone furoate monohydrate (50 ug/1)

Linked Drug Pages (1)

topcare allergy ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["NASAL"], "spl_id": "1396fed3-16fb-421a-89c5-4dd83706cd41", "openfda": {"unii": ["MTW0WEG809"], "rxcui": ["1797865"], "spl_set_id": ["9e7c759e-d2cb-4505-ad9f-38efaaaeefc2"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, SPRAY in 1 CARTON (76162-134-02)  / 120 SPRAY, METERED in 1 BOTTLE, SPRAY", "package_ndc": "76162-134-02", "marketing_start_date": "20230328"}, {"sample": false, "description": "1 BOTTLE, SPRAY in 1 CARTON (76162-134-11)  / 60 SPRAY, METERED in 1 BOTTLE, SPRAY", "package_ndc": "76162-134-11", "marketing_start_date": "20240314"}], "brand_name": "topcare allergy", "product_id": "76162-134_1396fed3-16fb-421a-89c5-4dd83706cd41", "dosage_form": "SPRAY, METERED", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "76162-134", "generic_name": "mometasone furoate monohydrate", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "topcare allergy", "active_ingredients": [{"name": "MOMETASONE FUROATE MONOHYDRATE", "strength": "50 ug/1"}], "application_number": "NDA215712", "marketing_category": "NDA", "marketing_start_date": "20230328", "listing_expiration_date": "20261231"}