Standardized allergenic · BLA
Mix Of 7 Standardized Grass Pollen NDC 0268-8076
Phleum pratense pollen 14286 [BAU]/mL + 6 more ingredients · Injection, Solution · Subcutaneous · ALK-Abello, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0268-8076-06 | 0026880760600268807606 | 5.5 mL in 1 VIAL (0268-8076-06)Marketed from Dec 18, 1997 | |
| 0268-8076-10 | 0026880761000268807610 | 10.5 mL in 1 VIAL (0268-8076-10)Marketed from Dec 18, 1997 | |
| 0268-8076-50 | 0026880765000268807650 | 53 mL in 1 VIAL (0268-8076-50)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)
- Mix Of 7 Standardized Grass Pollen
- Generic name (nonproprietary)
- agrostis gigantea pollen, dactylis glomerata pollen, festuca pratensis, lolium perenne pollen, phleum pratense pollen, poa pratensis pollen and anthoxanthum odoratum pollen
- Active ingredients
- Phleum pratense pollen — 14286 [BAU]/mLDactylis glomerata pollen — 14286 [BAU]/mLPoa pratensis pollen — 14286 [BAU]/mLAgrostis gigantea pollen — 14286 [BAU]/mLFestuca pratensis pollen — 14286 [BAU]/mLLolium perenne pollen — 14286 [BAU]/mLAnthoxanthum odoratum pollen — 14286 [BAU]/mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- ALK-Abello, Inc.NDC labeler code 0268
- Product type
- Standardized allergenic
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 103058
- Marketing start
- Listing expires
- Other FDA classes
- Allergens (Chemical structure)Allergens (Chemical structure)Allergens (Chemical structure)Allergens (Chemical structure)Allergens (Chemical structure)Allergens (Chemical structure)Allergens (Chemical structure)Cell-mediated Immunity (Physiologic effect)Cell-mediated Immunity (Physiologic effect)Cell-mediated Immunity (Physiologic effect)Cell-mediated Immunity (Physiologic effect)Cell-mediated Immunity (Physiologic effect)Cell-mediated Immunity (Physiologic effect)Cell-mediated Immunity (Physiologic effect)Increased Histamine Release (Physiologic effect)Increased Histamine Release (Physiologic effect)Increased Histamine Release (Physiologic effect)Increased Histamine Release (Physiologic effect)Increased Histamine Release (Physiologic effect)Increased Histamine Release (Physiologic effect)Increased Histamine Release (Physiologic effect)Increased IgG Production (Physiologic effect)Increased IgG Production (Physiologic effect)Increased IgG Production (Physiologic effect)Increased IgG Production (Physiologic effect)Increased IgG Production (Physiologic effect)Increased IgG Production (Physiologic effect)Increased IgG Production (Physiologic effect)Pollen (Chemical structure)Pollen (Chemical structure)Pollen (Chemical structure)Pollen (Chemical structure)Pollen (Chemical structure)Pollen (Chemical structure)Pollen (Chemical structure)
- Identifiers
- Product ID 0268-8076_f4170117-0559-46bb-a4fb-66138c6a9874SPL ID f4170117-0559-46bb-a4fb-66138c6a9874
- Pharmacologic class
- Non-Standardized Pollen Allergenic Extract; 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.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N400268807606followed by a unit qualifier and the quantityPackage 00268-8076-06. 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 0268-8076
- What is NDC 0268-8076?
- 0268-8076 is the product NDC for Mix Of 7 Standardized Grass Pollen, Phleum pratense pollen 14286 [BAU]/mL + 6 more ingredients injection, solution, listed with the FDA by ALK-Abello, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Mix Of 7 Standardized Grass Pollen (AGROSTIS GIGANTEA POLLEN, DACTYLIS GLOMERATA POLLEN, FESTUCA PRATENSIS, LOLIUM PERENNE POLLEN, PHLEUM PRATENSE POLLEN, POA PRATENSIS POLLEN and ANTHOXANTHUM ODORATUM POLLEN).
- What is the active ingredient?
- Phleum pratense pollen, Dactylis glomerata pollen, Poa pratensis pollen, Agrostis gigantea pollen, Festuca pratensis pollen, Lolium perenne pollen, Anthoxanthum odoratum 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 Mix Of 7 Standardized Grass Pollen?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under BLA 103058
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 |
|---|---|---|---|---|
| GRASS MIX Number 4-Sagrostis gigantea pollen, dactylis glomerata pollen, phleum pratense pollen and poa pratensis pollen | Poa pratensis pollen 25000 [BAU]/mL + 3 more ingredients | Injection, SolutionPercutaneous | ALK-Abello, Inc. | 0268-8026 |
| GRASS MIX Number 4-Sagrostis gigantea pollen, dactylis glomerata pollen, phleum pratense pollen and poa pratensis pollen | Poa pratensis pollen 25000 [BAU]/mL + 3 more ingredients | Injection, SolutionSubcutaneous | ALK-Abello, Inc. | 0268-8027 |
| Midwest Mix Of Standardized Grassagrostis gigantea pollen, dactylis glomerata pollen, phleum pratense pollen and poa pratensis pollen | Phleum pratense pollen 40000 [BAU]/mL + 3 more ingredients | Injection, SolutionSubcutaneous | ALK-Abello, Inc. | 0268-8077 |
| Mix Of 5 Standardized Grass Pollenagrostis gigantea pollen, anthoxanthum odoratum pollen, dactylis glomerata pollen, phleum pratense pollen and poa pratensis pollen | Phleum pratense pollen 20000 [BAU]/mL + 4 more ingredients | Injection, SolutionSubcutaneous | ALK-Abello, Inc. | 0268-8073 |
| Mix Of 6 Standardized Grass Pollenagrostis gigantea pollen, dactylis glomerata pollen, festuca pratensis, lolium perenne pollen, phleum pratense pollen and poa pratensis pollen | Phleum pratense pollen 16667 [BAU]/mL + 5 more ingredients | Injection, SolutionSubcutaneous | ALK-Abello, Inc. | 0268-8074 |
| Timothy, Standardized | Phleum pratense pollen 100000 [BAU]/mL | Injection, SolutionSubcutaneous | ALK-Abello, Inc. | 0268-0279 |
| Timothy, Standardized | Phleum pratense pollen 100000 [BAU]/mL | SolutionPercutaneous | ALK-Abello, Inc. | 0268-3063 |