Vaccine · BLA
Acam2000 NDC 71665-430
smallpox and mpox (vaccinia) vaccine, live · Vaccinia virus strain new york city board of health live antigen 100000000 [PFU]/mL · Injection, Powder, Lyophilized, For solution · Percutaneous · Emergent Product Development Gaithersburg Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71665-430-03 | 71665043003 | 8 CARTON in 1 CASE (71665-430-03) / 50 VIAL, MULTI-DOSE in 1 CARTON (71665-430-02) / .3 mL in 1 VIAL, MULTI-DOSE (71665-430-01)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)
- Acam2000
- Generic name (nonproprietary)
- smallpox and mpox (vaccinia) vaccine, live
- Active ingredients
- Vaccinia virus strain new york city board of health live antigen — 100000000 [PFU]/mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Percutaneous
- Labeler
- Emergent Product Development Gaithersburg Inc.NDC labeler code 71665
- Product type
- Vaccine
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125158
- Marketing start
- Listing expires
- Other FDA classes
- Actively Acquired Immunity (Physiologic effect)Smallpox Vaccine (Chemical structure)Unattenuated (Chemical structure)
- Identifiers
- Product ID 71665-430_52ed1149-d6e1-49af-bae5-96b9d248009cSPL ID 52ed1149-d6e1-49af-bae5-96b9d248009c
- Pharmacologic class
- Live Vaccinia Virus Vaccine
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
N471665043003followed by a unit qualifier and the quantityPackage 71665-0430-03. 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.
About NDC 71665-430
- What is NDC 71665-430?
- 71665-430 is the product NDC for Acam2000, Vaccinia virus strain new york city board of health live antigen 100000000 [PFU]/mL injection, powder, lyophilized, for solution, listed with the FDA by Emergent Product Development Gaithersburg Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Acam2000 (Smallpox and mpox (vaccinia) vaccine, live).
- What is the active ingredient?
- Vaccinia virus strain new york city board of health live antigen.
- Who is the labeler?
- Emergent Product Development Gaithersburg Inc., NDC labeler code 71665. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Acam2000?
- 1 other product NDC are listed under this name. See all Acam2000 NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Acam2000 products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| 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 | 71665-0330-03 |
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 |
| Diluent for ACAM2000diluent for smallpox and mpox (vaccinia) vaccine, live | — | SolutionPercutaneous | Emergent Product Development Gaithersburg Inc. | 71665-340 |
| Diluent for ACAM2000diluent for smallpox and mpox (vaccinia) vaccine, live | — | SolutionPercutaneous | Emergent Product Development Gaithersburg Inc. | 71665-440 |