Daraprim (pyrimethamine) NDC 69413-330

NDC codes

FDA NDC Directory

Product NDC (as listed)69413-330Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69413-0330Add 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
69413-330-10	69413033010	100 TABLET in 1 BOTTLE, PLASTIC (69413-330-10)Marketed from Jan 23, 1953
69413-330-30	69413033030	30 TABLET in 1 BOTTLE, PLASTIC (69413-330-30)Marketed from Jan 23, 1953

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): Daraprim
Generic name (nonproprietary): pyrimethamine
Active ingredients: Pyrimethamine — 25 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Vyera Pharmaceuticals LLC
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 008578
Marketing start: Jan 23, 1953
Listing expires: Dec 31, 2026
Other FDA classes: Dihydrofolate Reductase Inhibitors (Mechanism)
Identifiers: Product ID 69413-330_ca65359c-029c-44f4-ba89-c4058ddd4e30SPL ID ca65359c-029c-44f4-ba89-c4058ddd4e30SPL set ID 5368616d-6520-6f6e-2053-686b72656c69RxCUI 198182, 201912UNII Z3614QOX8WUPC 0369413330105, 0369413330303
Pharmacologic class: Dihydrofolate Reductase Inhibitor Antimalarial

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

N469413033010 followed by a unit qualifier and the quantity

Package 69413-0330-10. 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 Nov 11, 2021.

Indications (excerpt from the label)

INDICATIONS AND USAGE Treatment of Toxoplasmosis: DARAPRIM is indicated for the treatment of toxoplasmosis when used conjointly with a sulfonamide, since synergism exists with this combination.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 008578

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

FDA NDC Directory listings under NDA 008578
Product	Strength	Form · route	Labeler	Product NDC
Daraprimpyrimethamine	Pyrimethamine 25 mg/1	TabletOral	TILDE Sciences LLC	83649-330
Pyrimethamine	Pyrimethamine 25 mg/1	TabletOral	OAKRUM PHARMA, LLC	72647-330