Prescription drug · ANDA
Minoxidil NDC 51407-902
Minoxidil 10 mg/1 · Tablet · Oral · Golden State Medical Supply, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51407-902-01 | 51407090201 | 100 TABLET in 1 BOTTLE (51407-902-01)Marketed from Jul 11, 2024 |
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)
- Minoxidil
- Generic name (nonproprietary)
- minoxidil
- Active ingredients
- Minoxidil — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 071839
- Marketing start
- Listing expires
- Other FDA classes
- Arteriolar Vasodilation (Physiologic effect)
- Identifiers
- Product ID 51407-902_55f96a38-ea4b-9c5b-e063-6394a90a8356SPL ID 55f96a38-ea4b-9c5b-e063-6394a90a8356SPL set ID 1d134237-3e94-258e-e063-6294a90af556RxCUI 197986, 197987UNII 5965120SH1
- Pharmacologic class
- Arteriolar Vasodilator
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
N451407090201followed by a unit qualifier and the quantityPackage 51407-0902-01. 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)
INDICATIONS AND USAGE Because of the potential for serious adverse effects, minoxidil tablets are indicated only in the treatment of hypertension that is symptomatic or associated with target organ damage and is not manageable with maximum therapeutic doses of a diuretic plus two other antihypertensive drugs. At the present time use in milder degrees of hypertension is not recommended because the benefit-risk relationship in such patients has not been defined. Minoxidil reduced supine diastolic blood pressure by 20 mmHg or to 90 mmHg or less in approximately 75% of patients, most of who had hypertension that could not be controlled by other drugs.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 071839
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 |
|---|---|---|---|---|
| Minoxidil | Minoxidil 10 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-9299 |
| Minoxidil | Minoxidil 10 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-9620 |
| Minoxidil | Minoxidil 10 mg/1 | TabletOral | American Health Packaging | 68084-205 |
| Minoxidil | Minoxidil 10 mg/1 | TabletOral | Par Health USA, LLC | 49884-257 |
| Minoxidil | Minoxidil 10 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2230 |
| Minoxidil | Minoxidil 10 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2231 |
| Minoxidil | Minoxidil 10 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1490 |
| Minoxidil | Minoxidil 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-7760 |