Methamphetamine Hydrochloride

Product NDC
68308-115
11-digit product format
683080115
Labeler code
68308
Product ID
68308-115_ffc2cd39-e42b-5821-e053-6394a90a9974
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METHAMPHETAMINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Mayne Pharma Commercial LLC
Application
ANDA091189
Marketing category
ANDA
Marketing start
2010-04-26
Substance
METHAMPHETAMINE HYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Amphetamine Anorectic [EPC], Amphetamines [CS], Appetite Suppression [PE], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Increased Sympathetic Activity [PE]
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
Methamphetamine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHAMPHETAMINE HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii997F43Z9CV
Rxcui977860

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5440a9f9-c375-37ca-695e-afb814e3df29Product name220151120

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68308-115-01Methamphetamine Hydrochloride100 in 1 BOTTLE, PLASTICTABLET10011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68308-115-01EA - Each68308-1159e6e9717-56de-4524-adab-715f0a3321b512015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHAMPHETAMINE HYDROCHLORIDEACTIVE INGREDIENT997F43Z9CVMETHAMPHETAMINE HYDROCHLORIDE TABLET [MAYNE PHARMA]2
MethamphetamineACTIVE MOIETY44RAL3456CMETHAMPHETAMINE HYDROCHLORIDE TABLET [MAYNE PHARMA]2
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XMETHAMPHETAMINE HYDROCHLORIDE TABLET [MAYNE PHARMA]2
starch, cornINACTIVE INGREDIENTO8232NY3SJMETHAMPHETAMINE HYDROCHLORIDE TABLET [MAYNE PHARMA]2
stearic acidINACTIVE INGREDIENT4ELV7Z65APMETHAMPHETAMINE HYDROCHLORIDE TABLET [MAYNE PHARMA]2
talcINACTIVE INGREDIENT7SEV7J4R1UMETHAMPHETAMINE HYDROCHLORIDE TABLET [MAYNE PHARMA]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68308-115METHAMPHETAMINE HYDROCHLORIDE TABLET [MAYNE PHARMA COMMERCIAL LLC]11Current NDC, Legacy NDC, 1 package rows20230707_f31f580f-1f08-4a0f-b078-0b9e3308f712.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
977860methamphetamine HCl 5 MG Oral TabletPSNf31f580f-1f08-4a0f-b078-0b9e3308f71211
977860methamphetamine hydrochloride 5 MG Oral TabletSCDf31f580f-1f08-4a0f-b078-0b9e3308f71211

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68308-115-0168308011501100 TABLET in 1 BOTTLE, PLASTIC (68308-115-01) 100 tablet2010-04-260000-00-00NoNoCurrent