![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, 30-count — NDC 59617-0015-02 package photo](https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=854c9772-63b9-44a3-a11e-77b29c59e91d&name=oralair-15-2.jpg)
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, 30-count
by Stallergenes · 30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (59617-0015-2)
NDC 59617-0015-02
🏷️ FDA NDC (as labeled)
59617-0015-2
billing pads the package segment with a zero
This package
Contains30-count
Medicaid pays$14.88 / unit · 12 mo
Per package$446.34 / 30 tablets · Medicaid
Pack sizes2 compare ↓
Also comes in:
3 tablets 59617-0015-03
Brand
On market
Non-controlled
🗂️ Data synced Sep 17, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
🆔 Identity & classification
FDA NDC (as labeled)
59617-0015-2
Product NDC
59617-0015
11-digit billing NDC
59617001502
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
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
Biologic (Purple Book)
351(a)
Why two NDCs?
The FDA registers this code as 59617-0015-2 — 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 → 59617-0015-02. 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
LabelerStallergenes
FDA applicationBLA125471 (BLA)
Labeler code59617
First marketedApr 2014
Product typeStandardized Allergenic
Portfolio5 products on file
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 ORALAIR 300 IR SUBLINGUAL TAB Ingredient Gr Pol-Orc/Sw Ver/Rye/Kent/Tim
Patient education
Supplement & herbal interactions
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.
💬 Questions about ANTHOXANTHUM ODORATUM POLLEN, DACTYLIS GLOMERATA POLLEN, LOLIUM PERENNE POLLEN, PHLEUM PRATENSE POLLEN, and POA PRATENSIS POLLEN?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
💊 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.
🧪 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.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 | $14.88 | $446.34 / 30 tablets |
| 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.
🔁 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 59617-0015-02 | Stallergenes | 30 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.
⏳ 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.
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
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.
🗺️ 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 59617-0015-02, 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.
📅 Q1 2025 – Q4 2025 · 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
115
Units reimbursed last 4 qtrs
4.1K
Gross reimbursed last 4 qtrs
$60.7K
Avg / prescription
$527.84
Avg / unit
$14.8780
Latest quarter Q4 2025
26Rx
Fee-for-service vs managed care ⓘ
Fee-for-service · 115 Rx Managed care · 0 Rx
State Medicaid map
Units reimbursed · per 100k residents
9.531.8
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
Prescriptions—
Units—
Reimbursed—
🏆 Top states by units · per 100k residents
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.
Drug total (last 4 qtrs): 115 Rx · 4,080 units · $60,702 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 59617-0015-02 You're viewing this | 30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (59617-0015-2) | 2014-04-30 | Active |
| 59617-0015-03 | 1 BLISTER PACK in 1 BOX (59617-0015-3) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 2014-04-30 | Active |
In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in NDC 59617-0015-02?
NDC 59617-0015-02 is a 30-count package — 30 tablet, orally disintegrating in 1 blister pack.
What is the difference between NDC 59617-0015-02 and NDC 59617-0015-03?
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. NDC 59617-0015-02 is the 30-count package, while NDC 59617-0015-03 is the 3 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?
Bill NDC 59617-0015-02 — the 11-digit billing format is 59617001502. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
🧭 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 FDA registers it as 59617-0015-2, 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: 59617-0015-02, written without dashes as 59617001502. 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 59617-0015-02, the first segment (59617) is the labeler code FDA assigned to Stallergenes; the middle segment (0015) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) 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 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 3 tablets (59617-0015-03). 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.
📄 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 ▾
No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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.