NDC 50632-0010-01 — RabAvert Rabies Vaccine Kit

🆔 Identity & classification

FDA NDC (as labeled) 50632-010-01

Product NDC 50632-010

11-digit billing NDC 50632001001

NCPDP billing unit EA — each (per item)

Application # BLA103334

SPL Set ID 84b7a672-eeb1-4527-84ac-68196b156be2

DEA schedule Non-controlled

Marketing category BLA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 1997-11-11

Dosage form KIT

GPI-14 17100070201900

GPI class RabAvert

GCN Seq No 036447

GCN 33921

HICL code 035580

Ingredient (HICL) Rabies Vaccine (Pcec)/Pf

HIC1 code W

Therapeutic class — broad (HIC1) Anti-Infecting Agents

HIC2 code W7

Therapeutic class — intermediate (HIC2) Biologicals

HIC3 code W7J

Therapeutic class — specific (HIC3) Neurotoxic Virus Vaccines

AHFS code 80:12.00.00

AHFS class Vaccines

FDB label name RABAVERT RABIES VACC W-DILUENT

FDB brand name Rabavert

Legend status F — Federal legend — prescription drug or device

Biologic (Purple Book) 351(a)

Why two NDCs? The FDA registers this code as 50632-010-01 — a 5-3-2 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 product segment → 50632-0010-01. 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.

🏭 Manufacturer & labeler

LabelerBavarian Nordic A/S

FDA applicationBLA103334 (BLA)

Labeler code50632

First marketedNov 1997

Product typeVaccine

Portfolio10 products on file

🔎 All NDCs from Bavarian Nordic A/S

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.

🩺 Clinical

Label name RABAVERT RABIES VACC W-DILUENT Ingredient Rabies Vaccine (Pcec)/Pf

📖 What it is MedlinePlus · NLM

Why get vaccinated? Rabies vaccine may prevent rabies, a serious and usually fatal disease caused by the rabies virus. Rabies is mainly a disease of animals. Humans get rabies when they are bitten by infected animals. Rabies vaccine is given to people at high risk of rabies to protect them if they are exposed to rabies. It can also prevent the disease if it is given to a person that has been exposed to rabies. Infection with rabies can cause pain, fatigue, headaches, fever, and irritability. These symptoms are followed by seizures, hallucinations, paralysis, and death. These symptoms may occ...

Read the full MedlinePlus article ↗

📗 Our plain-language guide HelloPharmacist

📖 Read our full Rabies Vaccine guide →

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.

🧪 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.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.

Where does this data come from?

Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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.

💲 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 each	Per 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 · Q2 2026	$418.16	—
Medicare Part B allowsASP · 90675	$331.977 / 90675 unit	—

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.

🧾 Billing & reimbursement

FDA NDC (as labeled)50632-010-01

11-digit billing NDC50632-0010-01

Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)

HCPCS J-code90675

Descriptor1 ML

Billing units / pkg1 units

Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk

Where does this data come from?

The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
RabAvertthis 50632-0010-01	Bavarian	1 kit	—	—	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

🏛️

1997

First FDA approval

Oct 1997

📍

2026

Currently FDA-listed

29 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.

FDA Purple Book — biosimilars & interchangeables ⓘ

Reference product

Imovax RabiesRabies Vaccine RabavertRabies 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.

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.

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

Medicare Part D (outpatient prescription) spending for Rabavert — the program that covers self-administered drugs. 1 manufacturer.

⚠️ 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 Rabavert. 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

$271.2K

Claims incl. refills

586

Beneficiaries

324

Spend / beneficiary

$836.92

Spend / claim

$462.73

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.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
50632-0010-01 You're viewing this	1 KIT in 1 CARTON (50632-010-01) * 1 mL in 1 VIAL, GLASS (50632-013-01) * 1 mL in 1 SYRINGE (50632-011-01)	1997-11-11	Active

🧭 About this NDC listing & data coverage

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

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)	— Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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	✓ Available
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 FDA registers it as 50632-010-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 50632-0010-01, written without dashes as 50632001001. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 50632-0010-01, the first segment (50632) is the labeler code FDA assigned to Bavarian Nordic A/S; the middle segment (0010) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.

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 Bavarian Nordic A/S. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

Bavarian Nordic A/S 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.

Does this product have a billing J-code?

Yes — this NDC cross-references HCPCS code 90675 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.

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.

📄 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 ↗

🔗 Related NDC lookups

🧪 All Rabies Vaccine NDCsSame ingredient 🏭 All Bavarian labeler NDCsLabeler code 50632 📖 Read the Rabies Vaccine drug informationUses, warnings & side effects

💊 Related drugs in this class

Other drugs that share this product’s specific therapeutic class — Neurotoxic Virus Vaccines.

Tick-Borne Encephalitis Vaccin 00069-0297-02 Japanese Encephalitis Vacc/Pf 42515-0002-01 Rabies Vacc, Human Diploid/Pf 49281-0252-51 Dengue Vaccine, Live, Vero(Pf) 49281-0605-01 Yellow Fever Vaccine Live/Pf 49281-0913-01

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.