Prescription drug · ANDA
Pyrimethamine NDC 59651-590
Pyrimethamine 25 mg/1 · Tablet · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-590-01 | 5965105900159651059001 | 100 TABLET in 1 BOTTLE (59651-590-01)Marketed from Oct 25, 2022 | |
| 59651-590-30 | 5965105903059651059030 | 30 TABLET in 1 BOTTLE (59651-590-30)Marketed from Oct 25, 2022 |
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)
- Pyrimethamine
- Generic name (nonproprietary)
- pyrimethamine
- Active ingredients
- Pyrimethamine — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Aurobindo Pharma LimitedNDC labeler code 59651
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216983
- Marketing start
- Listing expires
- Other FDA classes
- Dihydrofolate Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 59651-590_3214e53b-6abb-4a20-b849-0558e79dac05SPL ID 3214e53b-6abb-4a20-b849-0558e79dac05SPL set ID 7aca002e-a538-4715-9121-a17bdb7f200cRxCUI 198182UNII Z3614QOX8WUPC 0359651590300
- 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
N459651059001followed by a unit qualifier and the quantityPackage 59651-0590-01. 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: Pyrimethamine tablets are 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 59651-590
- What is NDC 59651-590?
- 59651-590 is the product NDC for Pyrimethamine, Pyrimethamine 25 mg/1 tablet, listed with the FDA by Aurobindo Pharma Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pyrimethamine.
- What is the active ingredient?
- Pyrimethamine.
- Who is the labeler?
- Aurobindo Pharma Limited, NDC labeler code 59651. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Pyrimethamine?
- 3 other product NDCs are listed under this name. See all Pyrimethamine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Pyrimethamine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Pyrimethamine | Pyrimethamine 25 mg/1 | TabletOral | Teva Pharmaceuticals, Inc. | 0480-3720 | 00480-3720-0100480-3720-56 |
| Pyrimethamine | Pyrimethamine 25 mg/1 | TabletOral | DR.REDDYS LABORATORIES INC | 43598-672 | 43598-0672-0143598-0672-30 |
| Pyrimethamine | Pyrimethamine 25 mg/1 | TabletOral | OAKRUM PHARMA, LLC | 72647-330 | 72647-0330-0172647-0330-03 |