goprelto

Generic: cocaine hydrochloride

Labeler: lxo us inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name goprelto
Generic Name cocaine hydrochloride
Labeler lxo us inc.
Dosage Form SOLUTION
Routes
NASAL
Active Ingredients

cocaine hydrochloride 40 mg/mL

Manufacturer
LXO US Inc.

Identifiers & Regulatory

Product NDC 70839-359
Product ID 70839-359_0f897764-fe31-090a-e063-6294a90af106
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA209963
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2024-02-09

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70839359
Hyphenated Format 70839-359

Supplemental Identifiers

RxCUI
1995288 1995293
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 goprelto (source: ndc)
Generic Name cocaine hydrochloride (source: ndc)
Application Number NDA209963 (source: ndc)
Routes
NASAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, GLASS in 1 CARTON (70839-359-04) / 4 mL in 1 BOTTLE, GLASS
source: ndc

Packages (1)

70839-359-04 1 BOTTLE, GLASS in 1 CARTON (70839-359-04) / 4 mL in 1 BOTTLE, GLASS

Ingredients (1)

cocaine hydrochloride (40 mg/mL)

Linked Drug Pages (1)

Goprelto ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["NASAL"], "spl_id": "0f897764-fe31-090a-e063-6294a90af106", "openfda": {"unii": ["XH8T8T6WZH"], "rxcui": ["1995288", "1995293"], "spl_set_id": ["0f897764-fe30-090a-e063-6294a90af106"], "manufacturer_name": ["LXO US Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, GLASS in 1 CARTON (70839-359-04)  / 4 mL in 1 BOTTLE, GLASS", "package_ndc": "70839-359-04", "marketing_start_date": "20240209"}], "brand_name": "Goprelto", "product_id": "70839-359_0f897764-fe31-090a-e063-6294a90af106", "dosage_form": "SOLUTION", "product_ndc": "70839-359", "dea_schedule": "CII", "generic_name": "cocaine hydrochloride", "labeler_name": "LXO US Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Goprelto", "active_ingredients": [{"name": "COCAINE HYDROCHLORIDE", "strength": "40 mg/mL"}], "application_number": "NDA209963", "marketing_category": "NDA", "marketing_start_date": "20240209", "listing_expiration_date": "20261231"}