What is NDC 71665-440?

71665-440 is the product NDC for Diluent for ACAM2000 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?

Diluent for ACAM2000 (Diluent for smallpox and mpox (vaccinia) vaccine, live).

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 Diluent for ACAM2000?

1 other product NDC are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Diluent for ACAM2000 NDC 71665-440

NDC codes

FDA NDC Directory

Product NDC (as listed)71665-440Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71665-0440Add 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 NDC	11-digit (billing)	Package	Copy
71665-440-03	7166504400371665044003	8 CARTON in 1 CASE (71665-440-03) / 50 VIAL, GLASS in 1 CARTON (71665-440-02) / .6 mL in 1 VIAL, GLASS (71665-440-01)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
Labeler: Emergent Product Development Gaithersburg Inc.NDC labeler code 71665
Product type: Vaccine
Marketing category: BLA — Biologics License ApplicationApplication BLA 125158
Marketing start: Aug 31, 2007
Listing expires: Dec 31, 2026
Identifiers: Product ID 71665-440_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.

How CPT relates to drug billing

NDC on a medical claim

N471665044003 followed by a unit qualifier and the quantity

Package 71665-0440-03. 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 71665-440

What is NDC 71665-440?: 71665-440 is the product NDC for Diluent for ACAM2000 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?: Diluent for ACAM2000 (Diluent for smallpox and mpox (vaccinia) vaccine, live).
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 Diluent for ACAM2000?: 1 other product NDC are listed under this name. See all Diluent for ACAM2000 NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Diluent for ACAM2000 NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Diluent for ACAM2000diluent for smallpox and mpox (vaccinia) vaccine, live	—	SolutionPercutaneous	Emergent Product Development Gaithersburg Inc.	71665-340	71665-0340-03

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
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.	71665-340