NDC codes

FDA NDC Directory
Product NDC (as listed)71665-430Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71665-0430Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
71665-430-03716650430038 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
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.

How CPT relates to drug billing

NDC on a medical claim

N471665043003 followed by a unit qualifier and the quantity

Package 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.

Other NDCs under BLA 125158

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under BLA 125158
ProductStrengthForm · routeLabelerProduct NDC
Acam2000smallpox and mpox (vaccinia) vaccine, liveVaccinia virus strain new york city board of health live antigen 100000000 [PFU]/mLInjection, Powder, Lyophilized, For solutionPercutaneousEmergent Product Development Gaithersburg Inc.71665-330
Diluent for ACAM2000diluent for smallpox and mpox (vaccinia) vaccine, live—SolutionPercutaneousEmergent Product Development Gaithersburg Inc.71665-340
Diluent for ACAM2000diluent for smallpox and mpox (vaccinia) vaccine, live—SolutionPercutaneousEmergent Product Development Gaithersburg Inc.71665-440

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Acam2000 NDC 71665-430 | Med-Code