Prescription drug · BLA
Andexxa (andexanet alfa) NDC 0310-3200
Andexanet alfa 200 mg/20mL · Injection, Powder, Lyophilized, For solution · Intravenous · AstraZeneca Pharmaceuticals LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0310-3200-04 | 00310320004 | 4 VIAL, SINGLE-USE in 1 CARTON (0310-3200-04) / 20 mL in 1 VIAL, SINGLE-USE (0310-3200-01)Marketed from Jul 12, 2022 | |
| 0310-3200-05 | 00310320005 | 5 VIAL, SINGLE-USE in 1 CARTON (0310-3200-05) / 20 mL in 1 VIAL, SINGLE-USE (0310-3200-01)Marketed from Jul 3, 2023 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Andexxa
- Generic name (nonproprietary)
- andexanet alfa
- Active ingredients
- Andexanet alfa — 200 mg/20mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125586
- Marketing start
- Marketing end
- Identifiers
- Product ID 0310-3200_7c42c928-30f8-44ac-a040-d3087b2d6074SPL ID 7c42c928-30f8-44ac-a040-d3087b2d6074SPL set ID 2d9d90a6-63e6-46ef-96ff-dd6519ae7b6cRxCUI 2108128, 2108130UNII BI009E452R
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.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N400310320004followed by a unit qualifier and the quantityPackage 00310-3200-04. 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)
ANDEXXA is indicated for patients treated with rivaroxaban or apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. This indication is approved under accelerated approval based on the change from baseline in anti-FXa activity in healthy volunteers [see Clinical Studies (14) ] . An improvement in hemostasis has not been established. Continued approval for this indication may be contingent upon the results of studies that demonstrate an improvement in hemostasis in patients. ANDEXXA (coagulation factor Xa (recombinant), inactivated-zhzo) is a recombinant modified human factor Xa (FXa) protein indicated for patients treated with rivaroxaban or ap…
Excerpt only. Read the full label for complete information.