NDC 59617-0015-3 (59617-0015-03) — Oralair 300 IR ANTHOXANTHUM ODORATUM

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 59617-0015-3

Product NDC 59617-0015

11-digit billing NDC 59617001503

NCPDP billing unit EA — each (per item)

Application # BLA125471

SPL Set ID 854c9772-63b9-44a3-a11e-77b29c59e91d

Established class (EPC) Increas

Physiologic effect Cell-mediated Immunity; Increased Histamine Release

Chemical class Allergens

DEA schedule Non-controlled

Marketing category BLA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2014-04-30

Route SUBLINGUAL

Dosage form TABLET, ORALLY DISINTEGRATING

Substance DACTYLIS GLOMERATA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; LOLIUM PERENNE POLLEN; PHLEUM PRATENSE POLLEN; POA PRATENSIS POLLEN

Biologic (Purple Book) 351(a)

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

GPI-14 20109905200730

GPI class Oralair

GCN Seq No 070448

GCN 33970

HICL code 039918

Ingredient (HICL) Gr Pol-Orc/Sw Ver/Rye/Kent/Tim

HIC1 code W

Therapeutic class — broad (HIC1) Anti-Infecting Agents

HIC2 code W7

Therapeutic class — intermediate (HIC2) Biologicals

HIC3 code W7W

Therapeutic class — specific (HIC3) Allergenic Extracts, Therapeutic

AHFS code 80:02.00.00

AHFS class Allergenic Extracts (Therapeutic)

FDB label name ORALAIR 300 IR SUBLINGUAL TAB

FDB brand name Oralair

Legend status F — Federal legend — prescription drug or device

Quick answers

GSN (GCN sequence number): 070448
GCN: 33970
GPI-14 (Medi-Span): 20109905200730
HICL (First Databank): 039918
AHFS class code: 80:02.00.00

Why two NDCs? The FDA registers this code as 59617-0015-3 — a 5-4-1 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 package segment → 59617-0015-03. 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 8, 2026
RxNorm (NLM RxNav) · catalog refreshed Oct 8, 2026
Medi-Span GPI (licensed)
First Databank (licensed) · refreshed Oct 8, 2026

Clinical

Label name ORALAIR 300 IR SUBLINGUAL TAB Ingredient Gr Pol-Orc/Sw Ver/Rye/Kent/Tim

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 8, 2026
FDA label on DailyMed · label index refreshed Oct 8, 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 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 · 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: 30 tablets

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 · refreshed Oct 9, 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
59617-0015-02 59617-0015-2 Main listing	30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK	2014-04-30	—	Active
59617-0015-03 You're viewing this	1 BLISTER PACK in 1 BOX / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK	2014-04-30	—	Active

This pack shows little to no recent Medicaid volume — the 30 tablets pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in this package?

This is a 3-count package — 1 blister pack in 1 box / 3 tablet, orally disintegrating in 1 blister pack.

How does this package differ from NDC 59617-0015-02?

Both are Oralair 300 IR ANTHOXANTHUM ODORATUM POLLEN, DACTYLIS GLOMERATA POLLEN, LOLIUM PERENNE POLLEN, PHLEUM PRATENSE POLLEN, and POA PRATENSIS POLLEN 300 [IR]/1; 300 [IR]/1; 300 [IR]/1; 300 [IR]/1; 300 [IR]/1 Tablet, Orally Disintegrating — the drug itself is identical. This page's package is the 3-count one, while NDC 59617-0015-02 is the 30 tablets package.

What NDC number is used to bill for this package of Oralair 300 IR ANTHOXANTHUM ODORATUM POLLEN, DACTYLIS GLOMERATA POLLEN, LOLIUM PERENNE POLLEN, PHLEUM PRATENSE POLLEN, and POA PRATENSIS POLLEN 300 [IR]/1; 300 [IR]/1; 300 [IR]/1; 300 [IR]/1; 300 [IR]/1 Tablet, Orally Disintegrating?

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
Oralair 300 IR 300 [IR]/1; 300 [IR]/1; 300 [IR]/1; 300 [IR]/1; 300 [IR] 82454-0015-02	CENEXI	30 tablets	—	—	FDA listed	—
Oralair 300 IR 300 [IR]/1; 300 [IR]/1; 300 [IR]/1; 300 [IR]/1; 300 [IR]this 59617-0015-03	Stallergenes	3 tablets	—	—	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

🏛️

2014

First FDA approval

Apr 2014

📍

2026

Currently FDA-listed

12 years listed

🔓

·

Biosimilar pathway open

listed protections lapsed 2026

🧬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: The latest listed FDA patent/protection lapsed Apr 2026 — those protections no longer apply, though a biosimilar still needs FDA licensure and a manufacturer to market it.

📅 FDA approved Apr 1, 2014

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.

Patents & exclusivity — FDA Purple Book

Exclusivity RefProduct

2014 2016 2018 2020 2022 2024 2026

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	Apr 1, 2026

Common questions

Is there a biosimilar for ORALAIR 300 IR SUBLINGUAL TAB?

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

What it looks like

Color white

ShapeRound

Imprint300

Size6 mm

ScoringNot scored

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.

FDA label on DailyMed · label index refreshed Oct 8, 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.

UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.

4 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 8, 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

LabelerStallergenes

FDA applicationBLA125471 (BLA)

Labeler code59617

First marketedApr 2014

Product typeStandardized Allergenic

Portfolio5 products on file

More NDCs from Stallergenes labeler code 59617

🔎 All NDCs from Stallergenes

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 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.

30 tablets59617-0015-02 119 Rx · $63,356

3 tablets this page59617-0015-03 No Medicaid data

Drug total (last 4 qtrs): 119 Rx · 4,260 units · $63,356 gross reimbursed

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

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)	— 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 Stallergenes. 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 30 tablets (59617-0015-02). 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?

Stallergenes 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 Anthoxanthum Odoratum Pollen, Dactylis Glomerata Pollen, Lolium Perenne Pollen, Phleum Pratense Pollen, And Poa Pratensis Pollen NDCsSame ingredient 🏭 All Stallergenes labeler NDCsLabeler code 59617

Related drugs in this class

Other drugs that share this product’s specific therapeutic class — Allergenic Extracts, Therapeutic.

Mite-Dermatophagoides Farinae 00268-0275-10 Mite-D.pteronyssinus, Std 00268-0277-10 Grass Pollen-Timothy, Standard 00268-0279-10 Grass Pollen-Orchard Grass,Std 00268-0281-10 Grass Pollen-June Grass,Std 00268-0283-10 Grass Pollen-Redtop, Std 00268-0285-10 Grass Pollen-Sweet Vernal, Std 00268-0287-10 Grass Pollen-Perennial Rye,Std 00268-0289-10 Grass Pollen-Meadow Fescue,Std 00268-0291-10 Grass Pollen-Bermuda, Standard 00268-0293-10 Allergen Ext-Cattle Epithelium 00268-0603-10 Allergenic Ext-Dog Epithelium 00268-0621-10 Allergenic Ex-Horse Epithelium 00268-0628-10 Allergen Ext-Tree Pollen-Kapok 00268-0635-10 Allergenic Xt-Mouse Epithelium 00268-0638-10

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

Oralair 300 IR ANTHOXANTHUM ODORATUM POLLEN, DACTYLIS GLOMERATA POLLEN, LOLIUM PERENNE POLLEN, PHLEUM PRATENSE POLLEN, and POA PRATENSIS POLLEN 300 [IR]/1; 300 [IR]/1; 300 [IR]/1; 300 [IR]/1; 300 [IR]/1 Tablet, Orally Disintegrating, 3-count — NDC 59617-0015-3 (Billing 59617-0015-03)

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

What it looks like

Inactive Ingredients / Excipients

Inactive ingredient FAQ

Manufacturer & labeler

More NDCs from Stallergenes labeler code 59617

Full FDA label FDA SPL

Medicaid utilization by pack size

About this NDC listing & data coverage

Questions about this listing