FDA.reportPublic FDA data

Methamphetamine Hydrochloride

Product NDC
0054-0389
11-digit product format
000540389
Labeler code
0054
Product ID
0054-0389_9f3c9287-0615-4d2e-823d-673b33586e06
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methamphetamine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA203846
Marketing category
ANDA
Marketing start
2016-12-06
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0054-0389-252022-08-05C16284748780-1e4f33bdf-b17e-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use METHAMPHETAMINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METHAMPHETAMINE HYDROCHLORIDE TABLETS. METHAMPHETAMINE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 1943
0054-0389-252022-07-29C16284748780-1e4f33bdf-b17e-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use METHAMPHETAMINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METHAMPHETAMINE HYDROCHLORIDE TABLETS. METHAMPHETAMINE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 1943

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0054-0389-25Methamphetamine Hydrochloride100 in 1 BOTTLETABLET10014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-0389-25EA - Each0054-03891b222e21-829c-4375-a50d-850d994d301a12017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0054-0389METHAMPHETAMINE HYDROCHLORIDE TABLET [HIKMA PHARMACEUTICALS USA INC.]14Current NDC, Legacy NDC, 1 package rows20250523_90c02ac6-e5e2-4c97-8c68-81e4e389a195.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
977860methamphetamine HCl 5 MG Oral TabletPSN90c02ac6-e5e2-4c97-8c68-81e4e389a19514
977860methamphetamine hydrochloride 5 MG Oral TabletSCD90c02ac6-e5e2-4c97-8c68-81e4e389a19514

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0054-0389-2500054038925100 TABLET in 1 BOTTLE (0054-0389-25) 100 tablet2016-12-060000-00-00NoNoCurrent