NDC 0006-4119OTC monographFDA BLA · BLA125508

Gardasil 9

Active substance: Human Papillomavirus 9-valent Vaccine, Recombinant

FDA labeler: Merck Sharp & Dohme LLC

2 formulations • 4 package configurations
All 6 registered NDCs — click to copy
In one line

Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) NDC 0006-4119 converts to 00006-4119-03 for billing and bills under CPT 90651 at 1 Dose = 1 Unit.

FDA Approval & Market Entry Timeline

Official openFDA & DailyMed regulatory registration sequence
Listing: 0006-4119 Verified
1. Initial Approval
2014
First U.S. FDA clearance for Human Papillomavirus 9-valent Vaccine, Recombinant
2. FDA Application
BLA125508
Regulatory pathway: BLA
3. Market Entry Date
Dec 10, 2014
First commercial NDC distribution & launch date
4. Regulatory Status
Active Commercial Listing
Registration valid through Dec 31, 2027
Billing & reimbursement crosswalk

NDC • HCPCS Level II • CPT administration

HCPCS Level II J-Code
CPT 90651
Human Papillomavirus 9-valent vaccine (0.5 mL)
Billable unit: 1 Dose = 1 Unit
11-digit HIPAA NDC
00006-4119-03
Zero-padded 5-4-2 format
Standard conversion
CPT administration code
CPT 90651
Vaccine Product Code (Human Papillomavirus 9-valent vaccine (0.5 mL))
UB-04 revenue code
Rev 0636
0636 (Pharmacy - Extension of 0250 Drugs Requiring Detail)
Qualifier: UN

Interactive Unit Multiplier Calculator

CPT 90651

Calculate the exact number of billable HCPCS units to report on CMS-1500 / 837P claims based on the patient dose and single-dose vial waste.

DOSE
Units to report on claim:
100 Units
Based on 1 dose = 1 billable unit (100.0 exact)
Box 24 / HCPCS Quantity Formatted Line:CPT 90651 UN100 (N40006411903)
Always verify NDC package code, billable multiplier, and invoice qualifier with specific payer guidelines before claim filing.
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All registered strengths & packaging

Every registered strength and package for GARDASIL 9, with 10-digit and 11-digit NDC formats
Formulation / rolePackage NDCProduct NDC11-digit HIPAAPackaging detailCopy
30 ug/.5mL, 40 ug/.5mL, 60 ug/.5mL, 40 ug/.5mL, 20 ug/.5mL, 20 ug/.5mL, 20 ug/.5mL, 20 ug/.5mL, 20 ug/.5mL0006-4119-030006-411900006-4119-0310 VIAL, SINGLE-DOSE in 1 CARTON (0006-4119-03) / .5 mL in 1 VIAL, SINGLE-DOSE (0006-4119-01)
Vial component0006-4119-010006-411900006-4119-01Inner component of kit (0006-4119-03)
30 ug/.5mL, 40 ug/.5mL, 60 ug/.5mL, 40 ug/.5mL, 20 ug/.5mL, 20 ug/.5mL, 20 ug/.5mL, 20 ug/.5mL, 20 ug/.5mL0006-4121-020006-412100006-4121-0210 SYRINGE, GLASS in 1 CARTON (0006-4121-02) / .5 mL in 1 SYRINGE, GLASS (0006-4121-01)
Prefilled syringe0006-4121-010006-412100006-4121-01Inner component of kit (0006-4121-02)
FDA drug label

Prescribing information

No Structured Product Labeling submission was returned for this listing, so the sections below are derived from its FDA registration record rather than the manufacturer's label.

6 Label Sections
GARDASIL 9 is indicated for clinical therapeutic management as active pharmaceutical therapy containing HUMAN PAPILLOMAVIRUS TYPE 6 L1 CAPSID PROTEIN ANTIGEN (30 ug/.5mL), HUMAN PAPILLOMAVIRUS TYPE 11 L1 CAPSID PROTEIN ANTIGEN (40 ug/.5mL), HUMAN PAPILLOMAVIRUS TYPE 16 L1 CAPSID PROTEIN ANTIGEN (60 ug/.5mL), HUMAN PAPILLOMAVIRUS TYPE 18 L1 CAPSID PROTEIN ANTIGEN (40 ug/.5mL), HUMAN PAPILLOMAVIRUS TYPE 31 L1 CAPSID PROTEIN ANTIGEN (20 ug/.5mL), HUMAN PAPILLOMAVIRUS TYPE 33 L1 CAPSID PROTEIN ANTIGEN (20 ug/.5mL), HUMAN PAPILLOMAVIRUS TYPE 45 L1 CAPSID PROTEIN ANTIGEN (20 ug/.5mL), HUMAN PAPILLOMAVIRUS TYPE 52 L1 CAPSID PROTEIN ANTIGEN (20 ug/.5mL), HUMAN PAPILLOMAVIRUS TYPE 58 L1 CAPSID PROTEIN ANTIGEN (20 ug/.5mL).
Dosage must be individualized based on clinical therapeutic goals, route of administration (INTRAMUSCULAR), and patient response. Refer to licensed physician prescribing guidelines.
Supplied as INJECTION, SUSPENSION. Active ingredients: HUMAN PAPILLOMAVIRUS TYPE 6 L1 CAPSID PROTEIN ANTIGEN (30 ug/.5mL), HUMAN PAPILLOMAVIRUS TYPE 11 L1 CAPSID PROTEIN ANTIGEN (40 ug/.5mL), HUMAN PAPILLOMAVIRUS TYPE 16 L1 CAPSID PROTEIN ANTIGEN (60 ug/.5mL), HUMAN PAPILLOMAVIRUS TYPE 18 L1 CAPSID PROTEIN ANTIGEN (40 ug/.5mL), HUMAN PAPILLOMAVIRUS TYPE 31 L1 CAPSID PROTEIN ANTIGEN (20 ug/.5mL), HUMAN PAPILLOMAVIRUS TYPE 33 L1 CAPSID PROTEIN ANTIGEN (20 ug/.5mL), HUMAN PAPILLOMAVIRUS TYPE 45 L1 CAPSID PROTEIN ANTIGEN (20 ug/.5mL), HUMAN PAPILLOMAVIRUS TYPE 52 L1 CAPSID PROTEIN ANTIGEN (20 ug/.5mL), HUMAN PAPILLOMAVIRUS TYPE 58 L1 CAPSID PROTEIN ANTIGEN (20 ug/.5mL).
Contraindicated in patients with severe hypersensitivity to Human Papillomavirus 9-valent Vaccine, Recombinant or formulation components.
Review complete patient medical history, potential contraindications, and drug-drug interactions prior to initiation.
Supplied under FDA Labeler: Merck Sharp & Dohme LLC. Store according to manufacturer packaging specifications at controlled room temperature or refrigerated conditions as marked on commercial carton.
Billing code

Gardasil — CPT 90651

Human Papillomavirus 9-valent vaccine (0.5 mL). Billed at 1 Dose = 1 Unit.

Unit calculation
Labeler

Merck & Co., Inc.

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Pharmacologic class

Actively Acquired Immunity

Every other National Drug Code registered in the same established class.

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Terms used here11-digit NDCBillable unitN4 qualifier
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