Standardized allergenic · BLA
Timothy, Standardized NDC 0268-0279
Phleum pratense pollen 100000 [BAU]/mL · Injection, Solution · Subcutaneous · ALK-Abello, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0268-0279-10 | 00268027910 | 10 mL in 1 VIAL, MULTI-DOSE (0268-0279-10)Marketed from Dec 18, 1997 | |
| 0268-0279-50 | 00268027950 | 50 mL in 1 VIAL, MULTI-DOSE (0268-0279-50)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)
- Timothy, Standardized
- Generic name (nonproprietary)
- timothy, standardized
- Active ingredients
- Phleum pratense pollen — 100000 [BAU]/mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- ALK-Abello, Inc.
- Product type
- Standardized allergenic
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 103058
- 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 0268-0279_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.
- 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
N400268027910followed by a unit qualifier and the quantityPackage 00268-0279-10. 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.
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 |
|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Mix Of 7 Standardized Grass Pollenagrostis gigantea pollen, dactylis glomerata pollen, festuca pratensis, lolium perenne pollen, phleum pratense pollen, poa pratensis pollen and anthoxanthum odoratum pollen | Phleum pratense pollen 14286 [BAU]/mL + 6 more ingredients | Injection, SolutionSubcutaneous | ALK-Abello, Inc. | 0268-8076 |
| 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 |
| Timothy, Standardized | Phleum pratense pollen 100000 [BAU]/mL | SolutionPercutaneous | ALK-Abello, Inc. | 0268-3063 |