numbrino

Generic: cocaine hydrochloride nasal

Labeler: omnivium pharmaceuticals llc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name numbrino
Generic Name cocaine hydrochloride nasal
Labeler omnivium pharmaceuticals llc.
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

cocaine hydrochloride 40 mg/mL

Manufacturer
OMNIVIUM PHARMACEUTICALS LLC.

Identifiers & Regulatory

Product NDC 81665-300
Product ID 81665-300_b722df62-ac8d-49c0-b357-c814b89471fe
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA209575
DEA Schedule cii
Listing Expiration 2027-12-31
Marketing Start 2024-06-19

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 81665300
Hyphenated Format 81665-300

Supplemental Identifiers

RxCUI
1995288 2272608
UPC
0381665300026
UNII
XH8T8T6WZH

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 numbrino (source: ndc)
Generic Name cocaine hydrochloride nasal (source: ndc)
Application Number NDA209575 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, GLASS in 1 CARTON (81665-300-02) / 4 mL in 1 BOTTLE, GLASS
source: ndc

Packages (1)

81665-300-02 1 BOTTLE, GLASS in 1 CARTON (81665-300-02) / 4 mL in 1 BOTTLE, GLASS

Ingredients (1)

cocaine hydrochloride (40 mg/mL)

Linked Drug Pages (1)

NUMBRINO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "b722df62-ac8d-49c0-b357-c814b89471fe", "openfda": {"upc": ["0381665300026"], "unii": ["XH8T8T6WZH"], "rxcui": ["1995288", "2272608"], "spl_set_id": ["d724b5b4-6654-4bf5-9eed-e2c7943084ed"], "manufacturer_name": ["OMNIVIUM PHARMACEUTICALS LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, GLASS in 1 CARTON (81665-300-02)  / 4 mL in 1 BOTTLE, GLASS", "package_ndc": "81665-300-02", "marketing_start_date": "20240619"}], "brand_name": "NUMBRINO", "product_id": "81665-300_b722df62-ac8d-49c0-b357-c814b89471fe", "dosage_form": "SOLUTION", "product_ndc": "81665-300", "dea_schedule": "CII", "generic_name": "cocaine hydrochloride nasal", "labeler_name": "OMNIVIUM PHARMACEUTICALS LLC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NUMBRINO", "active_ingredients": [{"name": "COCAINE HYDROCHLORIDE", "strength": "40 mg/mL"}], "application_number": "NDA209575", "marketing_category": "NDA", "marketing_start_date": "20240619", "listing_expiration_date": "20271231"}