COCAINE HYDROCHLORIDE

Product NDC
70839-362
11-digit product format
708390362
Labeler code
70839
Product ID
70839-362_0fb0298f-9757-26e8-e063-6294a90ae8f2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
COCAINE HYDROCHLORIDE
Dosage form
SOLUTION
Route
NASAL
Labeler
LXO US INC.
Application
NDA209963
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2024-01-29
Substance
COCAINE HYDROCHLORIDE
Active strength
40 mg/mL
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
COCAINE HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
COCAINE HYDROCHLORIDE40 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiXH8T8T6WZH
Rxcui1995288

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
dc803e48-5aa8-4a87-8ab4-fcff7feb5dd5Product name120200610
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
8e5656e6-cd09-45b0-8d65-fbeaa5f1dc4eProduct name120180220
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70839-362-04COCAINE HYDROCHLORIDE4 mL in 1 BOTTLE, GLASSSOLUTION41
70839-362-04COCAINE HYDROCHLORIDE1 in 1 CARTONSOLUTION11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70839-362-04ML - Milliliter70839-3621ce3dd58-5758-44ef-962c-64959f176fc212024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70839-362COCAINE HYDROCHLORIDE SOLUTION [LXO US INC.]1Current NDC, 2 package rows20240129_0fb0298f-9756-26e8-e063-6294a90ae8f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1995288cocaine hydrochloride 4 % Nasal SolutionPSN0fb0298f-9756-26e8-e063-6294a90ae8f21
1995288cocaine hydrochloride 40 MG/ML Nasal SolutionSCD0fb0298f-9756-26e8-e063-6294a90ae8f21
1995288cocaine hydrochloride 4 % Nasal SolutionSY0fb0298f-9756-26e8-e063-6294a90ae8f21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70839-362-04708390362041 BOTTLE, GLASS in 1 CARTON (70839-362-04) / 4 mL in 1 BOTTLE, GLASS2024-01-29NoNoCurrent