NDC codes

FDA NDC Directory
Product NDC (as listed)42291-618Labeler and product segments. Claims need a package NDC.
Product NDC at billing width42291-0618Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
42291-618-0142291061801100 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

N442291061801 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 072708

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 072708
ProductStrengthForm · routeLabelerProduct NDC
MinoxidilMinoxidil 2.5 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC43353-342

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