cocaine hydrochloride nasal

Generic: cocaine hydrochloride nasal

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

Drug Facts

Product Profile

Brand Name cocaine hydrochloride nasal
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 81665-301
Product ID 81665-301_4aa46865-9d43-4f88-b5d3-81200c6ec945
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA209575
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2023-10-15

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 81665301
Hyphenated Format 81665-301

Supplemental Identifiers

RxCUI
1995288
UPC
0381665301023
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 cocaine hydrochloride nasal (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 (81665-301-02) / 4 mL in 1 BOTTLE, GLASS
source: ndc

Packages (1)

81665-301-02 1 BOTTLE, GLASS in 1 CARTON (81665-301-02) / 4 mL in 1 BOTTLE, GLASS

Ingredients (1)

cocaine hydrochloride (40 mg/mL)

Linked Drug Pages (1)

cocaine hydrochloride nasal ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "4aa46865-9d43-4f88-b5d3-81200c6ec945", "openfda": {"upc": ["0381665301023"], "unii": ["XH8T8T6WZH"], "rxcui": ["1995288"], "spl_set_id": ["4e3b2f6b-1b57-40bc-872b-01c0a3c7986e"], "manufacturer_name": ["OMNIVIUM PHARMACEUTICALS LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, GLASS in 1 CARTON (81665-301-02)  / 4 mL in 1 BOTTLE, GLASS", "package_ndc": "81665-301-02", "marketing_start_date": "20231015"}], "brand_name": "cocaine hydrochloride nasal", "product_id": "81665-301_4aa46865-9d43-4f88-b5d3-81200c6ec945", "dosage_form": "SOLUTION", "product_ndc": "81665-301", "dea_schedule": "CII", "generic_name": "cocaine hydrochloride nasal", "labeler_name": "OMNIVIUM PHARMACEUTICALS LLC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "cocaine hydrochloride nasal", "active_ingredients": [{"name": "COCAINE HYDROCHLORIDE", "strength": "40 mg/mL"}], "application_number": "NDA209575", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20231015", "listing_expiration_date": "20261231"}