Prescription drug · ANDA
Methamphetamine Hydrochloride NDC 75907-094
Methamphetamine hydrochloride 5 mg/1 · Tablet · Oral · Dr. Reddy's Laboratories Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 75907-094-01 | 75907009401 | 100 TABLET in 1 BOTTLE, PLASTIC (75907-094-01)Marketed from Nov 7, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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
- Labeler
- Dr. Reddy's Laboratories Inc
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091189
- 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 75907-094_c77198dd-fd98-ac84-9754-517e77c5c729SPL ID c77198dd-fd98-ac84-9754-517e77c5c729SPL set ID d0905e2c-a02f-ec4f-59a3-6f7ad0acbbf6RxCUI 977860UNII 997F43Z9CVUPC 0375907094019
- 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
N475907009401followed by a unit qualifier and the quantityPackage 75907-0094-01. 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)
1. INDICATIONS AND USAGE Methamphetamine hydrochloride tablets, USP is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 years of age and older. Methamphetamine hydrochloride tablets, USP is 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.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 091189
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Methamphetamine Hydrochloride | Methamphetamine hydrochloride 5 mg/1 | TabletOral | Mayne Pharma Commercial LLC | 68308-115 |