Gardasil 9 NDC 0006-4121

NDC codes

FDA NDC Directory

Product NDC (as listed)0006-4121Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00006-4121Add 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
0006-4121-02	00006412102	10 SYRINGE, GLASS in 1 CARTON (0006-4121-02) / .5 mL in 1 SYRINGE, GLASS (0006-4121-01)Marketed from Dec 10, 2014

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Gardasil 9
Generic name (nonproprietary): human papillomavirus 9-valent vaccine, recombinant
Active ingredients: Human papillomavirus type 6 l1 capsid protein antigen — 30 ug/.5mLHuman papillomavirus type 11 l1 capsid protein antigen — 40 ug/.5mLHuman papillomavirus type 16 l1 capsid protein antigen — 60 ug/.5mLHuman papillomavirus type 18 l1 capsid protein antigen — 40 ug/.5mLHuman papillomavirus type 31 l1 capsid protein antigen — 20 ug/.5mLHuman papillomavirus type 33 l1 capsid protein antigen — 20 ug/.5mLHuman papillomavirus type 45 l1 capsid protein antigen — 20 ug/.5mLHuman papillomavirus type 52 l1 capsid protein antigen — 20 ug/.5mLHuman papillomavirus type 58 l1 capsid protein antigen — 20 ug/.5mL
Dosage form: Injection, Suspension
Route: Intramuscular
Labeler: Merck Sharp & Dohme LLC
Product type: Vaccine
Marketing category: BLA — Biologics License ApplicationApplication BLA 125508
Marketing start: Dec 10, 2014
Listing expires: Dec 31, 2027
Other FDA classes: Actively Acquired Immunity (Physiologic effect)Actively Acquired Immunity (Physiologic effect)Actively Acquired Immunity (Physiologic effect)Actively Acquired Immunity (Physiologic effect)Papillomavirus Vaccines (Chemical structure)Papillomavirus Vaccines (Chemical structure)Papillomavirus Vaccines (Chemical structure)Papillomavirus Vaccines (Chemical structure)Inactivated (Chemical structure)Inactivated (Chemical structure)Inactivated (Chemical structure)Inactivated (Chemical structure)
Identifiers: Product ID 0006-4121_318ae380-736e-4519-b865-2f6b443d36baSPL ID 318ae380-736e-4519-b865-2f6b443d36ba
Pharmacologic class: Inactivated Human Papillomavirus 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 codeMed-Code curated

CPT 90651 — Vaccine product code for GARDASIL 9 (human papillomavirus 9-valent vaccine)

Billing unit: 1 dose. Units on the claim = dose given ÷ 1 dose.

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

N400006412102 followed by a unit qualifier and the quantity

Package 00006-4121-02. 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.

Other NDCs under BLA 125508

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

FDA NDC Directory listings under BLA 125508
Product	Strength	Form · route	Labeler	Product NDC
Gardasil 9human papillomavirus 9-valent vaccine, recombinant	Human papillomavirus type 6 l1 capsid protein antigen 30 ug/.5mL + 8 more ingredients	Injection, SuspensionIntramuscular	Merck Sharp & Dohme LLC	0006-4119