What is NDC 43353-342?

43353-342 is the product NDC for Minoxidil, Minoxidil 2.5 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 43353. 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?

45 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Minoxidil NDC 43353-342 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)43353-342Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43353-0342Add 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 NDC	11-digit (billing)	Package	Copy
43353-342-09	43353034209	9000 TABLET in 1 BOTTLE (43353-342-09)Marketed from Jun 2, 2017

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: Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 43353
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 072708
Marketing start: Aug 1, 2013
Listing expires: Dec 31, 2026
Other FDA classes: Arteriolar Vasodilation (Physiologic effect)
Identifiers: Product ID 43353-342_adc9595c-1b82-45f5-a679-ecf843d8baf2SPL ID adc9595c-1b82-45f5-a679-ecf843d8baf2SPL set ID 0dada91c-fa1c-4da4-ac0d-e68b017c8604RxCUI 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

N443353034209 followed by a unit qualifier and the quantity

Package 43353-0342-09. 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 Sep 6, 2017. 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)

About NDC 43353-342

What is NDC 43353-342?: 43353-342 is the product NDC for Minoxidil, Minoxidil 2.5 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. 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?: Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 43353. 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?: 45 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Minoxidil NDCs
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

All 46 Minoxidil NDCs

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
Product	Strength	Form · route	Labeler	Product NDC
Minoxidil	Minoxidil 2.5 mg/1	TabletOral	AvKARE	42291-618