Home › NDC Lookup › Ingredients › Human Papillomavirus Quadrivalent (Types... › 00006-4045-00
GARDASIL Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant 6 L1 CAPSID PROTEIN ANTIGEN 20 ug/.5mL; 11 L1 CAPSID PROTEIN ANTIGEN 40 ug/.5mL; 16 L1 CAPSID PROTEIN ANTIGEN 40 ug/.5mL; 18 L1 CAPSID PROTEIN ANTIGEN Injection, Suspension, 1 vial — NDC 00006-4045-00 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

GARDASIL Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant 6 L1 CAPSID PROTEIN ANTIGEN 20 ug/.5mL; 11 L1 CAPSID PROTEIN ANTIGEN 40 ug/.5mL; 16 L1 CAPSID PROTEIN ANTIGEN 40 ug/.5mL; 18 L1 CAPSID PROTEIN ANTIGEN Injection, Suspension, 1 vial — NDC 0006-4045-00 (Billing 00006-4045-00)

by Merck Sharp & Dohme LLC · 1 VIAL, SINGLE-DOSE in 1 CARTON / .5 mL in 1 VIAL, SINGLE-DOSE

This is a package of 1 vial of GARDASIL Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant 6 L1 CAPSID PROTEIN ANTIGEN 20 ug/.5mL; 11 L1 CAPSID PROTEIN ANTIGEN 40 ug/.5mL; 16 L1 CAPSID PROTEIN ANTIGEN 40 ug/.5mL; 18 L1 CAPSID PROTEIN ANTIGEN Injection, Suspension from Merck Sharp & Dohme LLC, marketed since Jun 2006 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 00006-4045-00
🏷️ FDA NDC (as labeled) 0006-4045-00 billing pads the labeler segment with a zero
This package
Contains1 vial Pack sizes2 compare ↓
Main listing for product 0006-4045 · Also comes in: 10 vials 0006-4045-41
Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 2, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 0006-4045-00 alone.

Record
FDA NDC Directory package listing · Vaccine
Code segments
0006 labeler · 4045 product · 00 package
Package marketed since
Jun 8, 2006
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 0006404500 0
FDA record last changed
Oct 2, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0006-4045-00
Product NDC 0006-4045
11-digit billing NDC 00006404500
NCPDP billing unit ML — per mL (volume)
Application # BLA125126
SPL Set ID 30952400-0572-4431-9150-3a41affffb9a
Established class (EPC) Inactivated Human Papillomavirus Vaccine; Inactivated Human Papilloma
Physiologic effect Actively Acquired Immunity
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2006-06-08
Route INTRAMUSCULAR
Dosage form INJECTION, SUSPENSION
Substance HUMAN PAPILLOMAVIRUS TYPE 6 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 11 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 16 L1 CAPSID PROTEIN ANTIGEN; HUMAN PAPILLOMAVIRUS TYPE 18 L1 CAPSID PROTEIN ANTIGEN
Biologic (Purple Book) 351(a)

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 060969
GCN 27124
HICL code 035081
Ingredient (HICL) Human Papilomvirus Vac,Qval/Pf
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W7
Therapeutic class — intermediate (HIC2) Biologicals
HIC3 code W7B
Therapeutic class — specific (HIC3) Viral/Tumorigenic Vaccines
AHFS code 80:12.00.00
AHFS class Vaccines
FDB label name GARDASIL VIAL
FDB brand name Gardasil
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 060969
  • GCN: 27124
  • HICL (First Databank): 035081
  • AHFS class code: 80:12.00.00
Why two NDCs? The FDA registers this code as 0006-4045-00 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00006-4045-00. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

Label name GARDASIL VIAL Ingredient Human Papilomvirus Vac,Qval/Pf

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 10 vials
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00006-4045-00 You're viewing this Main listing 1 VIAL, SINGLE-DOSE in 1 CARTON / .5 mL in 1 VIAL, SINGLE-DOSE 2006-06-08 — Active
00006-4045-41 0006-4045-41 10 VIAL, SINGLE-DOSE in 1 CARTON / .5 mL in 1 VIAL, SINGLE-DOSE 2006-06-08 — Active

Pack size FAQ

What quantity is in this package?
This package contains 1 vial — 1 vial, single-dose in 1 carton / .5 ml in 1 vial, single-dose.
How does this package differ from NDC 00006-4045-41?
Both are GARDASIL Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant 6 L1 CAPSID PROTEIN ANTIGEN 20 ug/.5mL; 11 L1 CAPSID PROTEIN ANTIGEN 40 ug/.5mL; 16 L1 CAPSID PROTEIN ANTIGEN 40 ug/.5mL; 18 L1 CAPSID PROTEIN ANTIGEN Injection, Suspension — the drug itself is identical. This page's package is the 1 vial one, while NDC 00006-4045-41 is the 10 vials package.
What NDC number is used to bill for this package of GARDASIL Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant 6 L1 CAPSID PROTEIN ANTIGEN 20 ug/.5mL; 11 L1 CAPSID PROTEIN ANTIGEN 40 ug/.5mL; 16 L1 CAPSID PROTEIN ANTIGEN 40 ug/.5mL; 18 L1 CAPSID PROTEIN ANTIGEN Injection, Suspension?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Gardasil 6 L1 CAPSID PROTEIN ANTIGEN 20 ug/.5mL; 11 L1 CAPSID PROTEIN ANTIGEN 40 ug/.5mL; 16 L1 CAPSID PROTEIN ANTIGEN 40 ug/.5mL; 18 L1 CAPSID PROTEIN ANTIGEN 00006-4109-02 Merck 10 syringes — — FDA listed —
Gardasil 6 L1 CAPSID PROTEIN ANTIGEN 20 ug/.5mL; 11 L1 CAPSID PROTEIN ANTIGEN 40 ug/.5mL; 16 L1 CAPSID PROTEIN ANTIGEN 40 ug/.5mL; 18 L1 CAPSID PROTEIN ANTIGENthis 00006-4045-00 Merck 1 vial — — FDA listed —
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & biosimilar status

🏛️
2006
First FDA approval
Jun 2006
📍
2026
Currently FDA-listed
20 years listed
🧬
·
Biosimilars
see Purple Book
🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.

What it looks like

Color White
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 0.78 mg / 0.5 mL UNII 4QD397987E
    An amino acid used as a buffer and stabilizer in medications. It helps maintain the pH balance and protects the active drug from breaking down during storage and use.
  • 50 ug / 0.5 mL UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • 35 ug / 0.5 mL UNII 91MBZ8H3QO
    Sodium borate is an inorganic salt compound used in medicines as a buffer to help maintain a stable pH level, and sometimes as a mild preservative or cleansing agent in topical formulations.
  • 9.56 mg / 0.5 mL UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

5 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerMerck Sharp & Dohme LLC
FDA applicationBLA125126 (BLA)
Labeler code00006
First marketedJun 2006
Product typeVaccine
Portfolio112 products on file

More NDCs from Merck Sharp & Dohme LLC labeler code 00006

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full FDA label FDA SPL

The complete FDA label for this product, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
📄 FDA label
📄 FDA label 19 words ▾

No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

About this NDC listing & data coverage

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Merck Sharp & Dohme LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 10 vials (00006-4045-41). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Merck Sharp & Dohme LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 00006-3862-03 · Merck 00006-4047-20 · Merck →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.