Prescription drug · ANDA
Minoxidil NDC 68084-205
Minoxidil 10 mg/1 · Tablet · Oral · American Health Packaging
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68084-205-01 | 6808402050168084020501 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-205-01) / 1 TABLET in 1 BLISTER PACK (68084-205-11)Marketed from Sep 5, 2007 |
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
- Labeler
- American Health PackagingNDC labeler code 68084
- 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 68084-205_59e01b3f-17d8-badc-e063-6294a90a3245SPL ID 59e01b3f-17d8-badc-e063-6294a90a3245SPL set ID 0b4fc036-9497-442b-b629-c4b386932789RxCUI 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
N468084020501followed by a unit qualifier and the quantityPackage 68084-0205-01. 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.
About NDC 68084-205
- What is NDC 68084-205?
- 68084-205 is the product NDC for Minoxidil, Minoxidil 10 mg/1 tablet, listed with the FDA by American Health Packaging. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Minoxidil.
- What is the active ingredient?
- Minoxidil.
- Who is the labeler?
- American Health Packaging, NDC labeler code 68084. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Minoxidil?
- 44 other product NDCs are listed under this name. See all Minoxidil NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Minoxidil products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Minoxidilminoxidil foam 5% (womens) | Minoxidil 50 mg/g | Aerosol, FoamTopical | Clarity Cosmetics Inc. | 84382-001 | 84382-0001-04 |
| Minoxidil | Minoxidil 50 mg/g | Aerosol, FoamTopical | P & L Development, LLC | 59726-151 | 59726-0151-6059726-0151-70 |
| Minoxidil | Minoxidil 50 mg/g | Aerosol, FoamTopical | P & L Development, LLC | 59726-122 | 59726-0122-60 |
| Minoxidil | Minoxidil 50 mg/g | Aerosol, FoamTopical | Keranique | 70550-116 | 70550-0116-0270550-0116-20 |
| minoxidil | Minoxidil 50 mg/g | Aerosol, FoamTopical | L. Perrigo Company | 0113-5129 | 00113-5129-0100113-5129-06 |
| Minoxidil | Minoxidil 50 mg/mL | Aerosol, FoamTopical | P & L Development, LLC | 59726-125 | 59726-0125-6059726-0125-70 |
| Minoxidil | Minoxidil 50 mg/g | Aerosol, FoamTopical | P & L Development, LLC | 59726-115 | 59726-0115-6059726-0115-6559726-0115-70 |
| Minoxidil | Minoxidil 50 mg/g | Aerosol, FoamTopical | P & L Development, LLC | 59726-116 | 59726-0116-6059726-0116-65 |
| Minoxidil | Minoxidil 2 g/100mL | SolutionTopical | Walgreens | 0363-9970 | 00363-9970-0200363-9970-06 |
| Minoxidil | Minoxidil 50 mg/mL | SolutionTopical | Walgreens | 0363-9973 | 00363-9973-06 |
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 | Par Health USA, LLC | 49884-257 |
| Minoxidil | Minoxidil 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-7760 |
| Minoxidil | Minoxidil 10 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-902 |
| 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 | 63629-9299 |
| Minoxidil | Minoxidil 10 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-9620 |
| Minoxidil | Minoxidil 10 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1490 |