Prescription drug · NDA
Wainua (Eplontersen) NDC 0310-9400
Eplontersen 45 mg/.8mL · Injection, Solution · Subcutaneous · AstraZeneca Pharmaceuticals LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0310-9400-01 | 00310940001 | 1 SYRINGE, GLASS in 1 CARTON (0310-9400-01) / .8 mL in 1 SYRINGE, GLASSMarketed from Dec 21, 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)
- Wainua
- Generic name (nonproprietary)
- eplontersen
- Active ingredients
- Eplontersen — 45 mg/.8mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- AstraZeneca Pharmaceuticals LPNDC labeler code 0310
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 217388
- Marketing start
- Listing expires
- Other FDA classes
- Decreased RNA Integrity (Physiologic effect)Increased Protein Breakdown (Physiologic effect)Antisense (Chemical structure)
- Identifiers
- Product ID 0310-9400_cea076d0-c827-4c46-9b36-418bf63d5a9dSPL ID cea076d0-c827-4c46-9b36-418bf63d5a9dSPL set ID d7dcb847-71dd-4fff-82d0-d43a465fc096RxCUI 2671944, 2671950, 2741485, 2741488UNII 0GRZ0F5XJ6
- Pharmacologic class
- Antisense Oligonucleotide; Transthyretin-directed RNA Interaction
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
N400310940001followed by a unit qualifier and the quantityPackage 00310-9400-01. 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)
WAINUA is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. WAINUA is a transthyretin-directed antisense oligonucleotide indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 0310-9400
- What is NDC 0310-9400?
- 0310-9400 is the product NDC for Wainua (eplontersen), Eplontersen 45 mg/.8mL injection, solution, listed with the FDA by AstraZeneca Pharmaceuticals LP. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Wainua (Eplontersen).
- What is the active ingredient?
- Eplontersen.
- Who is the labeler?
- AstraZeneca Pharmaceuticals LP, NDC labeler code 0310. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Wainua?
- 1 other product NDC are listed under this name. See all Wainua NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Wainua products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Wainuaeplontersen | Eplontersen 45 mg/.8mL | Injection, SolutionSubcutaneous | AstraZeneca Pharmaceuticals LP | 0310-9420 | 00310-9420-01 |
Other NDCs under NDA 217388
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 |
|---|---|---|---|---|
| Wainuaeplontersen | Eplontersen 45 mg/.8mL | Injection, SolutionSubcutaneous | AstraZeneca Pharmaceuticals LP | 0310-9420 |