Standardized allergenic · BLA
Orchard Grass, Standardized NDC 0268-3055
Dactylis glomerata pollen 100000 [BAU]/mL · Solution · Percutaneous · ALK-Abello, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0268-3055-06 | 00268305506 | 5 mL in 1 VIAL, MULTI-DOSE (0268-3055-06)Marketed from Dec 18, 1997 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Orchard Grass, Standardized
- Generic name (nonproprietary)
- orchard grass, standardized
- Active ingredients
- Dactylis glomerata pollen — 100000 [BAU]/mL
- Dosage form
- Solution
- Route
- Percutaneous
- Labeler
- ALK-Abello, Inc.NDC labeler code 0268
- Product type
- Standardized allergenic
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 103054
- Marketing start
- Listing expires
- Other FDA classes
- Allergens (Chemical structure)Cell-mediated Immunity (Physiologic effect)Increased Histamine Release (Physiologic effect)Increased IgG Production (Physiologic effect)Pollen (Chemical structure)
- Identifiers
- Product ID 0268-3055_2e2db5ce-9bd5-4ad3-94c0-45e59370fb28SPL ID 2e2db5ce-9bd5-4ad3-94c0-45e59370fb28
- Pharmacologic class
- Standardized Pollen Allergenic Extract
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
N400268305506followed by a unit qualifier and the quantityPackage 00268-3055-06. 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 0268-3055
- What is NDC 0268-3055?
- 0268-3055 is the product NDC for Orchard Grass, Standardized, Dactylis glomerata pollen 100000 [BAU]/mL solution, listed with the FDA by ALK-Abello, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Orchard Grass, Standardized.
- What is the active ingredient?
- Dactylis glomerata pollen.
- Who is the labeler?
- ALK-Abello, Inc., NDC labeler code 0268. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Orchard Grass, Standardized?
- 1 other product NDC are listed under this name. See all Orchard Grass, Standardized NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Orchard Grass, Standardized products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Orchard Grass, Standardized | Dactylis glomerata pollen 100000 [BAU]/mL | Injection, SolutionSubcutaneous | ALK-Abello, Inc. | 0268-0281 | 00268-0281-1000268-0281-50 |
Other NDCs under BLA 103054
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 |
|---|---|---|---|---|
| Orchard Grass, Standardized | Dactylis glomerata pollen 100000 [BAU]/mL | Injection, SolutionSubcutaneous | ALK-Abello, Inc. | 0268-0281 |