methamphetamine hydrochloride

Generic: methamphetamine hydrochloride

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methamphetamine hydrochloride
Generic Name methamphetamine hydrochloride
Labeler hikma pharmaceuticals usa inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

methamphetamine hydrochloride 5 mg/1

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0054-0389
Product ID 0054-0389_9f3c9287-0615-4d2e-823d-673b33586e06
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203846
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2016-12-06

Pharmacologic Class

Classes
amphetamine anorectic [epc] amphetamines [cs] appetite suppression [pe] central nervous system stimulant [epc] central nervous system stimulation [pe] increased sympathetic activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00540389
Hyphenated Format 0054-0389

Supplemental Identifiers

RxCUI
977860
UPC
0300540389253
UNII
997F43Z9CV

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name methamphetamine hydrochloride (source: ndc)
Generic Name methamphetamine hydrochloride (source: ndc)
Application Number ANDA203846 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (0054-0389-25)
source: ndc

Packages (1)

0054-0389-25 100 TABLET in 1 BOTTLE (0054-0389-25)

Ingredients (1)

methamphetamine hydrochloride (5 mg/1)

Linked Drug Pages (1)

Methamphetamine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "9f3c9287-0615-4d2e-823d-673b33586e06", "openfda": {"upc": ["0300540389253"], "unii": ["997F43Z9CV"], "rxcui": ["977860"], "spl_set_id": ["90c02ac6-e5e2-4c97-8c68-81e4e389a195"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (0054-0389-25)", "package_ndc": "0054-0389-25", "marketing_start_date": "20161206"}], "brand_name": "Methamphetamine Hydrochloride", "product_id": "0054-0389_9f3c9287-0615-4d2e-823d-673b33586e06", "dosage_form": "TABLET", "pharm_class": ["Amphetamine Anorectic [EPC]", "Amphetamines [CS]", "Appetite Suppression [PE]", "Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]", "Increased Sympathetic Activity [PE]"], "product_ndc": "0054-0389", "dea_schedule": "CII", "generic_name": "Methamphetamine Hydrochloride", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methamphetamine Hydrochloride", "active_ingredients": [{"name": "METHAMPHETAMINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA203846", "marketing_category": "ANDA", "marketing_start_date": "20161206", "listing_expiration_date": "20261231"}