NDC codes

FDA NDC Directory
Product NDC (as listed)50632-016Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50632-0016Add 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
50632-016-0250632001602506320016021 BLISTER PACK in 1 CARTON (50632-016-02) / 4 CAPSULE, COATED in 1 BLISTER PACK (50632-016-04)Marketed from Jul 1, 2024

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)
Vivotif
Generic name (nonproprietary)
salmonella typhi ty21a
Active ingredients
Salmonella typhi ty21a live antigen — 6000000000 [CFU]/1
Dosage form
Capsule, Coated
Route
Oral
Labeler
Bavarian Nordic A/SNDC labeler code 50632
Product type
Vaccine
Marketing category
BLA — Biologics License ApplicationApplication BLA 103123
Marketing start
Listing expires
Other FDA classes
Actively Acquired Immunity (Physiologic effect)Attenuated (Chemical structure)Typhoid (Chemical structure)
Identifiers
Product ID 50632-016_a53a8319-628e-49b4-98da-fb7dadbca801SPL ID a53a8319-628e-49b4-98da-fb7dadbca801
Pharmacologic class
Live Attenuated Salmonella Typhi 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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

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

N450632001602 followed by a unit qualifier and the quantity

Package 50632-0016-02. 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 50632-016

What is NDC 50632-016?
50632-016 is the product NDC for Vivotif (salmonella typhi ty21a), Salmonella typhi ty21a live antigen 6000000000 [CFU]/1 capsule, coated, 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?
Vivotif (Salmonella typhi Ty21a).
What is the active ingredient?
Salmonella typhi ty21a live antigen.
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 Vivotif?
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.

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