NDC codes

FDA NDC Directory
Product NDC (as listed)71334-220Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71334-0220Add 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 NDC11-digit (billing)PackageCopy
71334-220-11713340220111 BLISTER PACK in 1 CARTON (71334-220-11) / 7 TABLET, FILM COATED in 1 BLISTER PACKMarketed 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
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 71334-220_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

N471334022011 followed by a unit qualifier and the quantity

Package 71334-0220-11. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 216196

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 216196
ProductStrengthForm · routeLabelerProduct NDC
PyrukyndmitapivatMitapivat 20 mg/1Tablet, Film coatedOralAgios Pharmaceuticals, Inc.71334-210
PyrukyndmitapivatMitapivat 5 mg/1Tablet, Film coatedOralAgios Pharmaceuticals, Inc.71334-205
Pyrukyndmitapivat—KitAgios Pharmaceuticals, Inc.71334-225
PyrukyndmitapivatMitapivat 50 mg/1Tablet, Film coatedOralAgios Pharmaceuticals, Inc.71334-215
Pyrukyndmitapivat—KitAgios Pharmaceuticals, Inc.71334-230
AqvesmemitapivatMitapivat 100 mg/1Tablet, Film coatedOralAgios Pharmaceuticals, Inc.71334-235

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