Molindone Hydrochloride NDC 42806-338

NDC codes

FDA NDC Directory

Product NDC (as listed)42806-338Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42806-0338Add 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
42806-338-01	42806033801	100 TABLET in 1 BOTTLE (42806-338-01)Marketed from Oct 17, 2018

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): Molindone Hydrochloride
Generic name (nonproprietary): molindone hydrochloride
Active ingredients: Molindone hydrochloride — 25 mg/1
Dosage form: Tablet
Route: Oral
Labeler: EPIC PHARMA, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090453
Marketing start: Oct 17, 2018
Listing expires: Dec 31, 2026
Identifiers: Product ID 42806-338_d7c8ea49-c06c-441d-820e-def3920f7c1eSPL ID d7c8ea49-c06c-441d-820e-def3920f7c1eSPL set ID 1275e92f-9573-4d0c-8e77-1c9ac47696d2RxCUI 1298816, 1298906, 1298910UNII 1DWS68PNE6UPC 0342806337011
Pharmacologic class: Typical Antipsychotic

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

N442806033801 followed by a unit qualifier and the quantity

Package 42806-0338-01. 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 Dec 17, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Molindone Hydrochloride Tablets, USP are indicated for the management of schizophrenia. The efficacy of Molindone Hydrochloride Tablets, USP in schizophrenia was established in clinical studies which enrolled newly hospitalized and chronically hospitalized, acutely ill, schizophrenic patients as subjects.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 090453

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

FDA NDC Directory listings under ANDA 090453
Product	Strength	Form · route	Labeler	Product NDC
Molindone Hydrochloride	Molindone hydrochloride 5 mg/1	TabletOral	EPIC PHARMA, LLC	42806-336
Molindone Hydrochloride	Molindone hydrochloride 10 mg/1	TabletOral	EPIC PHARMA, LLC	42806-337