Vaccine · BLA
Diluent Component (Water for injection) NDC 50632-003
Water .65 mL/.65mL · Liquid · Subcutaneous · Bavarian Nordic A/S
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50632-003-02 | 5063200030250632000302 | 20 VIAL in 1 CARTON (50632-003-02) / .65 mL in 1 VIAL (50632-003-01)Marketed from Apr 14, 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)
- Diluent Component
- Generic name (nonproprietary)
- water for injection
- Active ingredients
- Water — .65 mL/.65mL
- Dosage form
- Liquid
- Route
- Subcutaneous
- Labeler
- Bavarian Nordic A/SNDC labeler code 50632
- Product type
- Vaccine
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125678
- Marketing start
- Listing expires
- Identifiers
- Product ID 50632-003_b8f81332-4a93-4b01-89b9-3952565ab2e9SPL ID b8f81332-4a93-4b01-89b9-3952565ab2e9
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
Immunization administration (CPT 90460–90474)
Giving a vaccine is reported separately from the vaccine product code, with an immunization administration code. Which code applies depends on the patient's age, the route and whether counselling was provided.
- NDC on a medical claim
N450632000302followed by a unit qualifier and the quantityPackage 50632-0003-02. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 50632-003
- What is NDC 50632-003?
- 50632-003 is the product NDC for Diluent Component (water for injection), Water .65 mL/.65mL liquid, listed with the FDA by Bavarian Nordic A/S. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Diluent Component (Water for Injection).
- What is the active ingredient?
- Water.
- Who is the labeler?
- Bavarian Nordic A/S, NDC labeler code 50632. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Diluent Component?
- 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 BLA 125678
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 |
|---|---|---|---|---|
| Jynneosvaccinia virus modified strain ankara-bavarian nordic non-replicating antigen | Vaccinia virus modified strain ankara-bavarian nordic non-replicating antigen 50000000 1/.5mL | Injection, SuspensionSubcutaneous | Bavarian Nordic A/S | 50632-001 |
| Jynneosvaccinia virus modified strain ankara-bavarian nordic non-replicating antigen | Vaccinia virus modified strain ankara-bavarian nordic non-replicating antigen 50000000 1/.5mL | Injection, Powder, Lyophilized, For suspensionSubcutaneous | Bavarian Nordic A/S | 50632-002 |
| Jynneosvaccinia virus modified strain ankara-bavarian nordic non-replicating antigen | Vaccinia virus modified strain ankara-bavarian nordic non-replicating antigen 50000000 1/.5mL | Injection, SuspensionSubcutaneous | Bavarian Nordic A/S | 50632-022 |
| Jynneosvaccinia virus modified strain ankara-bavarian nordic non-replicating antigen | Vaccinia virus modified strain ankara-bavarian nordic non-replicating antigen 50000000 1/.5mL | Injection, SuspensionSubcutaneous | Bavarian Nordic A/S | 50632-023 |
| Jynneosvaccinia virus modified strain ankara-bavarian nordic non-replicating antigen | Vaccinia virus modified strain ankara-bavarian nordic non-replicating antigen 50000000 1/.5mL | Injection, Powder, Lyophilized, For suspensionSubcutaneous | Bavarian Nordic A/S | 50632-024 |