Prescription drug · NDA
Pyrukynd (mitapivat) NDC 71334-230
Kit · Agios Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71334-230-13 | 71334023013 | 1 KIT in 1 CARTON (71334-230-13) * 7 TABLET, FILM COATED in 1 BLISTER PACK (71334-215-07) * 7 TABLET, FILM COATED in 1 BLISTER PACK (71334-210-07)Marketed from Feb 18, 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)
- Pyrukynd
- Generic name (nonproprietary)
- mitapivat
- Dosage form
- Kit
- Labeler
- Agios Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 216196
- Marketing start
- Listing expires
- Identifiers
- Product ID 71334-230_557b465d-234d-75a2-e063-6394a90a070aSPL ID 557b465d-234d-75a2-e063-6394a90a070aSPL set ID 4ccee896-e313-4c6c-9674-b4746ada0a90RxCUI 2594473, 2594479, 2594496, 2594498, 2594501, 2594503, 2594741, 2594742, 2594743, 2594744, 2594745, 2594746, 2594747, 2594748, 2594749, 2594750, 2594794, 2594795UNII 2WTV10SIKH
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N471334023013followed by a unit qualifier and the quantityPackage 71334-0230-13. 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)
PYRUKYND is indicated for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency. PYRUKYND is a pyruvate kinase activator indicated for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 216196
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 |
|---|---|---|---|---|
| Pyrukyndmitapivat | Mitapivat 20 mg/1 | Tablet, Film coatedOral | Agios Pharmaceuticals, Inc. | 71334-210 |
| Pyrukyndmitapivat | Mitapivat 5 mg/1 | Tablet, Film coatedOral | Agios Pharmaceuticals, Inc. | 71334-205 |
| Pyrukyndmitapivat | — | Kit | Agios Pharmaceuticals, Inc. | 71334-225 |
| Pyrukyndmitapivat | Mitapivat 50 mg/1 | Tablet, Film coatedOral | Agios Pharmaceuticals, Inc. | 71334-215 |
| Pyrukyndmitapivat | Mitapivat 5 mg/1 | Tablet, Film coatedOral | Agios Pharmaceuticals, Inc. | 71334-220 |
| Aqvesmemitapivat | Mitapivat 100 mg/1 | Tablet, Film coatedOral | Agios Pharmaceuticals, Inc. | 71334-235 |