Prescription drug · ANDA
Methamphetamine Hydrochloride NDC 0054-0389
Methamphetamine hydrochloride 5 mg/1 · Tablet · Oral · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0054-0389-25 | 00054038925 | 100 TABLET in 1 BOTTLE (0054-0389-25)Marketed from Dec 6, 2016 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Methamphetamine Hydrochloride
- Generic name (nonproprietary)
- methamphetamine hydrochloride
- Active ingredients
- Methamphetamine hydrochloride — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203846
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Amphetamines (Chemical structure)Appetite Suppression (Physiologic effect)Central Nervous System Stimulation (Physiologic effect)Increased Sympathetic Activity (Physiologic effect)
- Identifiers
- Product ID 0054-0389_9f3c9287-0615-4d2e-823d-673b33586e06SPL ID 9f3c9287-0615-4d2e-823d-673b33586e06SPL set ID 90c02ac6-e5e2-4c97-8c68-81e4e389a195RxCUI 977860UNII 997F43Z9CVUPC 0300540389253
- Pharmacologic class
- Amphetamine Anorectic; Central Nervous System Stimulant
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400054038925followed by a unit qualifier and the quantityPackage 00054-0389-25. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Methamphetamine hydrochloride tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 years of age and older. • Methamphetamine hydrochloride tablets are a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 years of age and older. ( 1 )
Excerpt only. Read the full label for complete information.