NDC codes

FDA NDC Directory
Product NDC (as listed)51285-138Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51285-0138Add 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
51285-138-50512850138501 KIT in 1 CARTON (51285-138-50) * 100 TABLET, COATED in 1 BOTTLE (51285-175-02) * 100 TABLET, COATED in 1 BOTTLE (51285-174-02)Marketed from Sep 16, 2011

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

Generic name (nonproprietary)
adenovirus type 4 and type 7 vaccine, live
Dosage form
Kit
Labeler
Teva Women's Health LLCNDC labeler code 51285
Product type
Vaccine
Marketing category
BLA — Biologics License ApplicationApplication BLA 125296
Marketing start
Listing expires
Identifiers
Product ID 51285-138_494b1046-969a-4189-98cc-be10f6a08a8eSPL ID 494b1046-969a-4189-98cc-be10f6a08a8e

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

N451285013850 followed by a unit qualifier and the quantity

Package 51285-0138-50. 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 51285-138

What is NDC 51285-138?
51285-138 is the product NDC for Adenovirus Type 4 and Type 7 Vaccine, Live kit, listed with the FDA by Teva Women's Health LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Adenovirus Type 4 and Type 7 Vaccine, Live.
Who is the labeler?
Teva Women's Health LLC, NDC labeler code 51285. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Adenovirus Type 4 and Type 7 Vaccine, Live?
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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