Prescription drug · NDA
Pyrukynd (Mitapivat) NDC 71334-205
Mitapivat 5 mg/1 · Tablet, Film coated · Oral · Agios Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71334-205-05 | 71334020505 | 4 BLISTER PACK in 1 CARTON (71334-205-05) / 14 TABLET, FILM COATED in 1 BLISTER PACK (71334-205-14)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
- Active ingredients
- Mitapivat — 5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Agios Pharmaceuticals, Inc.NDC labeler code 71334
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 216196
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2B6 Inducers (Mechanism)Cytochrome P450 2C19 Inducers (Mechanism)Cytochrome P450 2C8 Inducers (Mechanism)Cytochrome P450 2C9 Inducers (Mechanism)Cytochrome P450 3A Inducers (Mechanism)P-Glycoprotein Inhibitors (Mechanism)Pyruvate Kinase Activators (Mechanism)UGT1A1 Inducers (Mechanism)
- Identifiers
- Product ID 71334-205_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
- Pharmacologic class
- Pyruvate Kinase Activator
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
N471334020505followed by a unit qualifier and the quantityPackage 71334-0205-05. 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.
About NDC 71334-205
- What is NDC 71334-205?
- 71334-205 is the product NDC for Pyrukynd (mitapivat), Mitapivat 5 mg/1 tablet, film coated, listed with the FDA by Agios Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pyrukynd (Mitapivat).
- What is the active ingredient?
- Mitapivat.
- Who is the labeler?
- Agios Pharmaceuticals, Inc., NDC labeler code 71334. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Pyrukynd?
- 5 other product NDCs are listed under this name. See all Pyrukynd NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Pyrukynd products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Pyrukyndmitapivat | Mitapivat 20 mg/1 | Tablet, Film coatedOral | Agios Pharmaceuticals, Inc. | 71334-210 | 71334-0210-20 |
| Pyrukyndmitapivat | Mitapivat 50 mg/1 | Tablet, Film coatedOral | Agios Pharmaceuticals, Inc. | 71334-215 | 71334-0215-50 |
| Pyrukyndmitapivat | Mitapivat 5 mg/1 | Tablet, Film coatedOral | Agios Pharmaceuticals, Inc. | 71334-220 | 71334-0220-11 |
| Pyrukyndmitapivat | — | Kit | Agios Pharmaceuticals, Inc. | 71334-225 | 71334-0225-12 |
| Pyrukyndmitapivat | — | Kit | Agios Pharmaceuticals, Inc. | 71334-230 | 71334-0230-13 |
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 |
|---|---|---|---|---|
| Aqvesmemitapivat | Mitapivat 100 mg/1 | Tablet, Film coatedOral | Agios Pharmaceuticals, Inc. | 71334-235 |
| Pyrukyndmitapivat | Mitapivat 20 mg/1 | Tablet, Film coatedOral | Agios Pharmaceuticals, Inc. | 71334-210 |
| 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 |
| Pyrukyndmitapivat | — | Kit | Agios Pharmaceuticals, Inc. | 71334-225 |
| Pyrukyndmitapivat | — | Kit | Agios Pharmaceuticals, Inc. | 71334-230 |