Prescription drug · NDA
Daraprim (Pyrimethamine) NDC 83649-330
Pyrimethamine 25 mg/1 · Tablet · Oral · TILDE Sciences LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83649-330-01 | 8364903300183649033001 | 100 TABLET in 1 BOTTLE, PLASTIC (83649-330-01)Marketed from Dec 12, 2023 | |
| 83649-330-03 | 8364903300383649033003 | 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 LLCNDC labeler code 83649
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 008578
- Marketing start
- Listing expires
- 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
N483649033001followed by a unit qualifier and the quantityPackage 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 .
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.
About NDC 83649-330
- What is NDC 83649-330?
- 83649-330 is the product NDC for Daraprim (pyrimethamine), Pyrimethamine 25 mg/1 tablet, listed with the FDA by TILDE Sciences LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Daraprim (Pyrimethamine).
- What is the active ingredient?
- Pyrimethamine.
- Who is the labeler?
- TILDE Sciences LLC, NDC labeler code 83649. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Daraprim?
- 1 other product NDC are listed under this name. See all Daraprim NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Daraprim products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Daraprimpyrimethamine | Pyrimethamine 25 mg/1 | TabletOral | Vyera Pharmaceuticals LLC | 69413-330 | 69413-0330-1069413-0330-30 |
Other NDCs under NDA 008578
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| 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 |