NDC Code(s) : 64950-362-04
Packager : Genus Lifesciences Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

cocaine hydrochloridecocaine hydrochloride SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64950-362
Route of Administration NASAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
COCAINE HYDROCHLORIDE(UNII: XH8T8T6WZH)
(COCAINE - UNII:I5Y540LHVR) 		COCAINE HYDROCHLORIDE40 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C GREEN NO. 3(UNII: 3P3ONR6O1S)
SODIUM BENZOATE(UNII: OJ245FE5EU)
WATER(UNII: 059QF0KO0R)
Product Characteristics
Color green Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:64950-362-041 in 1 CARTON 06/04/2018
14 mL in 1 BOTTLE, GLASS Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA209963 06/04/2018

LABELER - Genus Lifesciences Inc.(113290444)

Establishment
Name Address ID/FEI Business Operations
Genus Lifesciences Inc. 113290444 manufacture(64950-362)

PRINCIPAL DISPLAY PANEL

NDC 64950-362-04
COCAINE
HYDROCHLORIDE
nasal solution

CII

160 mg/4 mL

For Topical Use Only.
Not for Injection or Ophthalmic Use

Single-unit

Each 1 mL contains:
Cocaine Hydrochloride, USP
40 mg

(equivalent to 142.4 mg/4 mL [35.6 mg/mL] cocaine)

Rx Only
4 mL

Genus
Lifesciences Inc.

PRINCIPAL DISPLAY PANEL - 4 mL Bottle Carton