Daraprim (pyrimethamine) NDC 83649-330

NDC codes

FDA NDC Directory

Product NDC (as listed)83649-330Labeler and product segments. Claims need a package NDC.

Product NDC at billing width83649-0330Add 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
83649-330-01	83649033001	100 TABLET in 1 BOTTLE, PLASTIC (83649-330-01)Marketed from Dec 12, 2023
83649-330-03	83649033003	30 TABLET in 1 BOTTLE, PLASTIC (83649-330-03)Marketed from Dec 12, 2023

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: TILDE Sciences 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 83649-330_c7c0666e-57ea-45e4-b3b4-e3950a173011SPL ID c7c0666e-57ea-45e4-b3b4-e3950a173011SPL set ID f634f34b-0952-4dd3-9da3-f84b6ab823deRxCUI 198182, 201912UNII Z3614QOX8WUPC 0383649330012, 0383649330036
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

N483649033001 followed by a unit qualifier and the quantity

Package 83649-0330-01. 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 7, 2023.

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	Vyera Pharmaceuticals LLC	69413-330
Pyrimethamine	Pyrimethamine 25 mg/1	TabletOral	OAKRUM PHARMA, LLC	72647-330