Vaccine · BLA
Diluent for ACAM2000 NDC 71665-340
diluent for smallpox and mpox (vaccinia) vaccine, live · Solution · Percutaneous · Emergent Product Development Gaithersburg Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71665-340-03 | 71665034003 | 8 CARTON in 1 CASE (71665-340-03) / 50 VIAL, GLASS in 1 CARTON (71665-340-02) / .6 mL in 1 VIAL, GLASS (71665-340-01)Marketed from Aug 31, 2007 |
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 for ACAM2000
- Generic name (nonproprietary)
- diluent for smallpox and mpox (vaccinia) vaccine, live
- Dosage form
- Solution
- Route
- Percutaneous
- Product type
- Vaccine
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125158
- Marketing start
- Listing expires
- Identifiers
- Product ID 71665-340_52ed1149-d6e1-49af-bae5-96b9d248009cSPL ID 52ed1149-d6e1-49af-bae5-96b9d248009c
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
N471665034003followed by a unit qualifier and the quantityPackage 71665-0340-03. 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.
Other NDCs under BLA 125158
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 |
|---|---|---|---|---|
| Acam2000smallpox and mpox (vaccinia) vaccine, live | Vaccinia virus strain new york city board of health live antigen 100000000 [PFU]/mL | Injection, Powder, Lyophilized, For solutionPercutaneous | Emergent Product Development Gaithersburg Inc. | 71665-330 |
| Acam2000smallpox and mpox (vaccinia) vaccine, live | Vaccinia virus strain new york city board of health live antigen 100000000 [PFU]/mL | Injection, Powder, Lyophilized, For solutionPercutaneous | Emergent Product Development Gaithersburg Inc. | 71665-430 |
| Diluent for ACAM2000diluent for smallpox and mpox (vaccinia) vaccine, live | — | SolutionPercutaneous | Emergent Product Development Gaithersburg Inc. | 71665-440 |