Prescription drug · ANDA
Minoxidil NDC 42291-618
Minoxidil 2.5 mg/1 · Tablet · Oral · AvKARE
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42291-618-01 | 42291061801 | 100 TABLET in 1 BOTTLE (42291-618-01)Marketed from Aug 1, 2013 |
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 — 2.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- AvKARE
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 072708
- Marketing start
- Listing expires
- Other FDA classes
- Arteriolar Vasodilation (Physiologic effect)
- Identifiers
- Product ID 42291-618_48e97f58-ac9b-0967-e063-6294a90a26a5SPL ID 48e97f58-ac9b-0967-e063-6294a90a26a5SPL set ID 02d7399f-94cc-f718-f214-587301edd138RxCUI 197986, 197987UNII 5965120SH1UPC 0342291618015, 0342291619012
- 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
N442291061801followed by a unit qualifier and the quantityPackage 42291-0618-01. 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 mm Hg or to 90 mm Hg 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 072708
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 2.5 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-342 |