Standardized allergenic · BLA
Oralair NDC 82454-0025
Kit · CENEXI HSC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82454-0025-1 | 82454002501 | 1 KIT in 1 CARTON (82454-0025-1) * 1 TABLET, ORALLY DISINTEGRATING in 1 BOX * 2 TABLET, ORALLY DISINTEGRATING in 1 BOXMarketed from Apr 30, 2014 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Oralair
- Generic name (nonproprietary)
- anthoxanthum odoratum pollen, dactylis glomerata pollen, lolium perenne pollen, phelum pratense pollen, and poa pratensis pollen
- Dosage form
- Kit
- Labeler
- CENEXI HSCNDC labeler code 82454
- Product type
- Standardized allergenic
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125471
- Marketing start
- Listing expires
- Identifiers
- Product ID 82454-0025_d44ece12-6365-fef4-e053-2a95a90a0decSPL ID d44ece12-6365-fef4-e053-2a95a90a0dec
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N482454002501followed by a unit qualifier and the quantityPackage 82454-0025-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
The FDA listing for this product does not reference a label (SPL) set.
About NDC 82454-0025
- What is NDC 82454-0025?
- 82454-0025 is the product NDC for Oralair kit, listed with the FDA by CENEXI HSC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Oralair (ANTHOXANTHUM ODORATUM POLLEN, DACTYLIS GLOMERATA POLLEN, LOLIUM PERENNE POLLEN, PHELUM PRATENSE POLLEN, and POA PRATENSIS POLLEN).
- Who is the labeler?
- CENEXI HSC, NDC labeler code 82454. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Oralair?
- 3 other product NDCs are listed under this name. See all Oralair NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Oralair products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Oralairanthoxanthum odoratum pollen, dactylis glomerata pollen, lolium perenne pollen, phelum pratense pollen, and poa pratensis pollen | — | Kit | Stallergenes | 59617-0020 | 59617-0020-01 |
| Oralairanthoxanthum odoratum pollen, dactylis glomerata pollen, lolium perenne pollen, phelum pratense pollen, and poa pratensis pollen | — | Kit | Stallergenes | 59617-0025 | 59617-0025-01 |
| Oralairanthoxanthum odoratum pollen, dactylis glomerata pollen, lolium perenne pollen, phelum pratense pollen, and poa pratensis pollen | — | Kit | CENEXI HSC | 82454-0020 | 82454-0020-01 |
Other NDCs under BLA 125471
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Oralair 300 IRanthoxanthum odoratum pollen, dactylis glomerata pollen, lolium perenne pollen, phleum pratense pollen, and poa pratensis pollen | Dactylis glomerata pollen 300 [IR]/1 + 4 more ingredients | Tablet, Orally disintegratingSublingual | CENEXI HSC | 82454-0015 |
| Oralairanthoxanthum odoratum pollen, dactylis glomerata pollen, lolium perenne pollen, phelum pratense pollen, and poa pratensis pollen | — | Kit | CENEXI HSC | 82454-0020 |
| Oralair 100 IRanthoxanthum odoratum pollen, dactylis glomerata pollen, lolium perenne pollen, phleum pratense pollen, and poa pratensis pollen | Poa pratensis pollen 100 [IR]/1 + 4 more ingredients | Tablet, Orally disintegratingSublingual | Stallergenes | 59617-0010 |
| Oralair 300 IRanthoxanthum odoratum pollen, dactylis glomerata pollen, lolium perenne pollen, phleum pratense pollen, and poa pratensis pollen | Dactylis glomerata pollen 300 [IR]/1 + 4 more ingredients | Tablet, Orally disintegratingSublingual | Stallergenes | 59617-0015 |
| Oralair 300 IRanthoxanthum odoratum pollen, dactylis glomerata pollen, lolium perenne pollen, phleum pratense pollen, and poa pratensis pollen | Poa pratensis pollen 300 [IR]/1 + 4 more ingredients | Tablet, Orally disintegratingSublingual | Stallergenes | 59617-0016 |
| Oralairanthoxanthum odoratum pollen, dactylis glomerata pollen, lolium perenne pollen, phelum pratense pollen, and poa pratensis pollen | — | Kit | Stallergenes | 59617-0020 |
| Oralairanthoxanthum odoratum pollen, dactylis glomerata pollen, lolium perenne pollen, phelum pratense pollen, and poa pratensis pollen | — | Kit | Stallergenes | 59617-0025 |