NDC codes

FDA NDC Directory
Product NDC (as listed)71334-235Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71334-0235Add 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
71334-235-00713340235004 BLISTER PACK in 1 CARTON (71334-235-00) / 14 TABLET, FILM COATED in 1 BLISTER PACK (71334-235-14)Marketed from Dec 23, 2025

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)
Aqvesme
Generic name (nonproprietary)
mitapivat
Active ingredients
Mitapivat — 100 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 71334-235_5a0c9383-d37f-9838-e063-6294a90ac7b5SPL ID 5a0c9383-d37f-9838-e063-6294a90ac7b5SPL set ID 1d4e2654-1636-0d01-e063-6394a90af303RxCUI 2730660, 2730666UNII 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

N471334023500 followed by a unit qualifier and the quantity

Package 71334-0235-00. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

AQVESME is indicated for the treatment of anemia in adults with alpha- or beta-thalassemia. AQVESME is a pyruvate kinase activator indicated for the treatment of anemia in adults with alpha- or beta-thalassemia. ( 1.1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71334-235

What is NDC 71334-235?
71334-235 is the product NDC for Aqvesme (mitapivat), Mitapivat 100 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?
Aqvesme (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 Aqvesme?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

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 5 mg/1Tablet, Film coatedOralAgios Pharmaceuticals, Inc.71334-205
PyrukyndmitapivatMitapivat 20 mg/1Tablet, Film coatedOralAgios Pharmaceuticals, Inc.71334-210
PyrukyndmitapivatMitapivat 50 mg/1Tablet, Film coatedOralAgios Pharmaceuticals, Inc.71334-215
PyrukyndmitapivatMitapivat 5 mg/1Tablet, Film coatedOralAgios Pharmaceuticals, Inc.71334-220
Pyrukyndmitapivat—KitAgios Pharmaceuticals, Inc.71334-225
Pyrukyndmitapivat—KitAgios Pharmaceuticals, Inc.71334-230

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