NDC 0069-2465-01 (00069-2465-01) — Abrysvo Respiratory Syncytial Virus

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0069-2465-01

Product NDC 0069-2465

11-digit billing NDC 00069246501

NCPDP billing unit EA — each (per item)

Application # BLA125769

SPL Set ID be18292e-b1a2-4815-a0ed-003efaa6bea3

DEA schedule Non-controlled

Marketing category BLA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2024-07-30

Route INTRAMUSCULAR

Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Substance RECOMBINANT STABILIZED RSV A PREFUSION F ANTIGEN; RECOMBINANT STABILIZED RSV B PREFUSION F ANTIGEN

Biologic (Purple Book) 351(a)

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

GCN Seq No 084892

GCN 54296

HICL code 048999

Ingredient (HICL) Rsv Vacc, Pref A And Pref B/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 ABRYSVO ACT-O-VIAL

FDB brand name Abrysvo

Legend status F — Federal legend — prescription drug or device

Quick answers

GSN (GCN sequence number): 084892
GCN: 54296
HICL (First Databank): 048999
AHFS class code: 80:12.00.00

Why two NDCs? The FDA registers this code as 0069-2465-01 — 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 → 00069-2465-01. 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.

FDA openFDA NDC Directory · synced Oct 8, 2026
FDA label on DailyMed · label index refreshed Oct 6, 2026
RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
Medi-Span GPI (licensed)
First Databank (licensed) · refreshed Oct 8, 2026

Clinical

Label name ABRYSVO ACT-O-VIAL Ingredient Rsv Vacc, Pref A And Pref B/Pf

📖 What it is MedlinePlus · NLM

Why get vaccinated? RSV Vaccine is used to prevent lower respiratory tract disease (LRTD) that may occur with infection due to Respiratory Synctial Virus (RSV). RSV is a common virus that causes mild, cold-like symptoms such as runny nose, decrease in appetite, coughing, sneezing, fever, wheezing. However, LRTD can be more serious in infants and older adults. Those older adults at higher risk of severe disease from RSV disease include those: with chronic heart or lung diseases with weakened immune systems nursing home or long-term care facility residents LRTD may cause shortness of brea...

Read the full MedlinePlus article ↗

Patient education

📘 MedlinePlus patient leaflet ↗

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.

MedlinePlus (NLM) · refreshed Oct 1, 2026
FDA label on DailyMed · label index refreshed Oct 6, 2026

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 system	Per mL	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	$309.28	$154.64 / 0.5 ml
Medicare drug plans payPart D · quarterly	No Part D plan price is available for this NDC in our data.

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.

CMS NADAC weekly file
CMS ASP pricing files · refreshed Sep 20, 2026
CMS Medicaid State Drug Utilization Data · through Q1 2026
CMS Part D plan pricing files · refreshed Sep 24, 2026
VA National Acquisition Center price file

Packaging — all sizes for this product

Package NDC	Description	Marketing start	Marketing end	Status
00069-2465-01 You're viewing this	1 VIAL in 1 CARTON / .5 mL in 1 VIAL	2024-07-30	—	Active
00069-2465-10 0069-2465-10 Main listing	10 VIAL in 1 CARTON / .5 mL in 1 VIAL	2024-07-30	—	Active

This pack accounts for about 21% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓

Pack size FAQ

What quantity is in this package?

This package contains 1 vial — 1 vial in 1 carton / .5 ml in 1 vial.

How does this package differ from NDC 00069-2465-10?

Both are Abrysvo Respiratory Syncytial Virus Vaccine .06 mg/.5mL; .06 mg/.5mL Injection, Powder, Lyophilized, For Solution — the drug itself is identical. This page's package is the 1 vial one, while NDC 00069-2465-10 is the 10 vials package.

What NDC number is used to bill for this package of Abrysvo Respiratory Syncytial Virus Vaccine .06 mg/.5mL; .06 mg/.5mL Injection, Powder, Lyophilized, For Solution?

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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Abrysvo .06 mg/.5mL; .06 mg/.5mLthis 00069-2465-01	Pfizer	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.

FDA openFDA NDC Directory · synced Oct 8, 2026
FDA Purple Book · refreshed Oct 5, 2026
CMS NADAC weekly file

Availability & biosimilar status

🏛️

2023

First FDA approval

May 2023

📍

2026

Currently FDA-listed

3 years listed

🛡️

2035

Latest patent/protection listed

not a guaranteed launch date

🧬Biologic — competition comes from biosimilars

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

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through May 2035. This may affect when biosimilars become widely available, but it is not a guaranteed launch date.

📅 FDA approved May 31, 2023 ⏳ ~8.6 yr to latest listed protection

Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.

FDA Purple Book — biosimilars & interchangeables ⓘ

Reference product

AbrysvoRespiratory Syncytial Virus Vaccine mresviaRespiratory Syncytial Virus Vaccine

🔒 No FDA-licensed biosimilars or interchangeable biosimilars are listed yet for this biologic. It currently has no biosimilar competition in the FDA Purple Book.

Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.

Patents & exclusivity — FDA Purple Book

Exclusivity RefProduct

2023 2025 2027 2029 2031 2033 2035

Today

LOE

Biologic patent Exclusivity

🏛️Reference-product exclusivity

A flat 12 years of FDA market protection from first licensure. No biosimilar can be licensed before it ends — regardless of patents.

🧪Listed biologic patents

Patents the reference maker lists covering the molecule, formulation, or manufacturing. A biosimilar generally can’t launch until these resolve.

🔁Interchangeability

An interchangeable biosimilar may be substituted at the pharmacy (state laws vary). The first one can earn its own exclusivity period.

🛈 What do these terms mean?

Biologic patent: A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
Reference-product exclusivity: A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
Interchangeable exclusivity: The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
Earliest biosimilar (LOE): The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.

Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.

FDA exclusivity

Code	What it grants	Expires
RefProduct	Reference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this date	May 31, 2035

Common questions

Is there a biosimilar for ABRYSVO ACT-O-VIAL?

No FDA-licensed biosimilar is currently listed for this biologic in the FDA Purple Book.

Why do different websites show different biosimilar dates?

Biosimilar availability isn’t based on one single date. Some sources use the reference-product exclusivity, some use the last listed patent, and patent litigation, settlements, and licenses can all change the real-world launch date. This page shows the underlying Purple Book dates so you can see why estimates differ.

Can a biosimilar launch before the last patent expires?

Sometimes. A biosimilar maker may settle with the reference manufacturer or receive a license to launch earlier. In other cases, the last listed protection delays competition.

What does “current Purple Book estimate” mean?

It means we’re using the latest patent and exclusivity dates currently listed in the FDA Purple Book. It is not a guaranteed launch date.

What does “FDA listed” mean?

It means the product appears in the FDA’s official directory. That’s a good sign a product exists for the U.S. market, but on its own it does not confirm a pharmacy can get it today. Where we have recent retail pricing data, we label it “Availability likely” instead.

What does a patent or protection date mean here?

It’s the latest date currently listed in the FDA Purple Book for a patent or exclusivity on the reference biologic. It can affect when a biosimilar becomes widely available — but it is not a guaranteed launch date. Settlements and licenses can move the real date earlier or later.

Built from the FDA Purple Book Patent List (patents the reference-product sponsor has publicly listed under the BPCIA) plus reference-product exclusivity. Biosimilars cannot launch until these clear; patent litigation and settlements can shift the real date. Biologics have no small-molecule generics — competition comes from FDA-licensed biosimilars, not the Orange 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.

FDA Purple Book · refreshed Oct 5, 2026

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.

22.5 mg / 0.5 mL UNII 3OWL53L36A
A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
0.08 mg / 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.
1.1 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.
11.3 mg / 0.5 mL UNII C151H8M554
A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
0.11 mg / 0.5 mL UNII 023C2WHX2V
Tromethamine is a chemical buffer that helps maintain the proper acidity level in liquid medicines. It neutralizes acids and stabilizes the solution so the medication remains effective and safe throughout its shelf life.
1.04 mg / 0.5 mL UNII 383V75M34E
A salt form of tromethamine, an organic base compound. It functions as a buffer to help maintain the medicine's pH level and improve stability during storage.

6 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.

FDA label on DailyMed · label index refreshed Oct 6, 2026
FDA openFDA NDC Directory · synced Oct 8, 2026

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

LabelerPfizer Laboratories Div Pfizer Inc

FDA applicationBLA125769 (BLA)

Labeler code00069

First marketedJul 2024

Product typeVaccine

Portfolio242 products on file

More NDCs from Pfizer Laboratories Div Pfizer Inc labeler code 00069

🔎 All NDCs from Pfizer Laboratories Div Pfizer Inc

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.

FDA openFDA NDC Directory · synced Oct 8, 2026
Drugs@FDA

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 ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.

💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.

📅 Q2 2025 – Q1 2026 · 4 quarters of data

ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.

Prescriptions last 4 qtrs

743

Units reimbursed last 4 qtrs

740

Gross reimbursed last 4 qtrs

$228.9K

Avg / prescription

$308.03

Avg / unit

$309.28

Latest quarter Q1 2026

367Rx

Fee-for-service vs managed care ⓘ

43% FFS 57% MCO

Fee-for-service · 319 Rx Managed care · 424 Rx

State Medicaid map

Units reimbursed · per 100k residents

0.22.9

gray = no data reported ⓘ

Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.

Tap or hover a state

…for its Medicaid breakdown

🏆 Top states by units · per 100k residents

1 Idaho 2.9 /100k

2 Michigan 1.5 /100k

3 New York 1.2 /100k

4 Virginia 0.7 /100k

5 Louisiana 0.7 /100k

6 Georgia 0.6 /100k

7 Florida 0.4 /100k

8 North Carolina 0.3 /100k

National units — by quarter

💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.

10 vials00069-2465-10 2,820 Rx · $883,172

1 vial this page00069-2465-01 743 Rx · $228,864

Drug total (last 4 qtrs): 3,563 Rx · 3,559 units · $1,112,036 gross reimbursed

Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Abrysvo — the program that covers self-administered drugs. 2 manufacturers.

⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Abrysvo. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.

Period

Total Part D spend

$59.42M

Claims incl. refills

181.9K

Beneficiaries

181.6K

Spend / beneficiary

$327.26

Spend / claim

$326.70

Trend by period

💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

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	✓ Available
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)	✓ Available

“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 Pfizer Laboratories Div Pfizer Inc. 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 (00069-2465-10). 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?

Pfizer Laboratories Div Pfizer Inc 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.

Related NDC lookups

🧪 All Respiratory Syncytial Virus Vaccine NDCsSame ingredient 🏭 All Pfizer labeler NDCsLabeler code 00069

Related drugs in this class

Other drugs that share this product’s specific therapeutic class — Viral/Tumorigenic Vaccines.

Human Papilomvirus Vac,Qval/Pf 00006-4045-00 Hepatitis B Virus Vaccine/Pf 00006-4093-02 Hepatitis A Virus Vaccine/Pf 00006-4095-02 Hpv Vaccine 9-Valent/Pf 00006-4119-03 Ebola (Zaire)Vacc,Live,Vero/Pf 00006-4293-02 Varicella Vaccine Live/Pf 00006-4826-00 Chikungunya Vaccine, Live/Pf 42515-0003-01 Hepatitis B Vaccine/Cpg1018/Pf 43528-0003-05 Varicella-Zoster Ge/As01B/Pf 50090-3372-00 Hep B Vaccine/Dp(A)T-Polio/Pf 50090-7541-00 Smallpox And Mpox Live Vacc/Pf 50632-0001-02 Chikungunya Vaccine, Recomb/Pf 50632-0018-02 Adenovirus Live Types-4,7 Vacc 51285-0138-50 Hepatitis A And B Vaccine/Pf 58160-0815-52 Rsvpref3 Antigen/As01E/Pf 58160-0848-11

Where does this data come from?

Other drugs sharing this product’s First Databank therapeutic class (HIC3). Each links to that NDC’s page in our directory.

First Databank (licensed) · refreshed Oct 8, 2026

Abrysvo Respiratory Syncytial Virus Vaccine .06 mg/.5mL; .06 mg/.5mL Injection, Powder, Lyophilized, For Solution, 1 vial — NDC 0069-2465-01 (Billing 00069-2465-01)

NDC database record

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

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

Clinical

Patient education

Supplement & herbal interactions

Pricing

Packaging — all sizes for this product

Pack size FAQ

Therapeutic equivalents

Availability & biosimilar status

Inactive Ingredients / Excipients

Inactive ingredient FAQ

Manufacturer & labeler

More NDCs from Pfizer Laboratories Div Pfizer Inc labeler code 00069

Full FDA label FDA SPL

Medicaid utilization & spend

Medicaid utilization by pack size

Medicare Part D spend CMS · PART D · 2026 (Q1)

About this NDC listing & data coverage

Questions about this listing