NDC Code(s) : 0378-8115-01
Packager : Mylan Pharmaceuticals Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Methamphetamine HydrochlorideMethamphetamine Hydrochloride TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-8115
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Methamphetamine Hydrochloride(UNII: 997F43Z9CV)
(Methamphetamine - UNII:44RAL3456C) 		Methamphetamine Hydrochloride5 mg
Inactive Ingredients
Ingredient Name Strength
starch, corn(UNII: O8232NY3SJ)
lactose monohydrate(UNII: EWQ57Q8I5X)
stearic acid(UNII: 4ELV7Z65AP)
talc(UNII: 7SEV7J4R1U)
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 6 mm
Flavor Imprint Code 115
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0378-8115-01100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product26/04/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091189 04/26/2010 10/31/2018

PRINCIPAL DISPLAY PANEL

NDC 0378-8115-01

MYLAN ®

CII

METHAMPHETAMINE
HYDROCHLORIDE
TABLETS, USP
5 mg

PHARMACIST: Dispense the accompanying
Medication Guide to each patient.

100 TABLETS

Rx only

PRINCIPAL DISPLAY PANEL - 5 mg Tablet Bottle Label