Non-standardized allergenic · BLA
Betula Nigra Pollen (River birch red) NDC 0268-6609
Betula nigra pollen .05 g/mL · Injection, Solution · Percutaneous · ALK-Abello, Inc.
NDC codes
FDA NDC DirectoryProduct NDC (as listed)0268-6609Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00268-6609Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0268-6609-06 | 00268660906 | 5 mL in 1 VIAL, MULTI-DOSE (0268-6609-06)Marketed from Jan 1, 1965 |
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)
- Betula Nigra Pollen
- Generic name (nonproprietary)
- river birch red
- Active ingredients
- Betula nigra pollen — .05 g/mL
- Dosage form
- Injection, Solution
- Route
- Percutaneous
- Labeler
- ALK-Abello, Inc.NDC labeler code 0268
- Product type
- Non-standardized allergenic
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 103753
- 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 0268-6609_22a0440f-2b25-45c4-997a-ea67c4ccea74SPL ID 22a0440f-2b25-45c4-997a-ea67c4ccea74
- Pharmacologic class
- Non-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
N400268660906followed by a unit qualifier and the quantityPackage 00268-6609-06. 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 0268-6609
- What is NDC 0268-6609?
- 0268-6609 is the product NDC for Betula Nigra Pollen (river birch red), Betula nigra pollen .05 g/mL injection, 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?
- Betula Nigra Pollen (River Birch Red).
- What is the active ingredient?
- Betula nigra 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 Betula Nigra Pollen?
- 2 other product NDCs are listed under this name. See all Betula Nigra Pollen NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Betula Nigra Pollen products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Betula Nigra Pollenbirch river red | Betula nigra pollen .1 g/mL | Injection, SolutionSubcutaneous | ALK-Abello, Inc. | 0268-1062 | 00268-1062-50 |
| Betula Nigra Pollenbirch river red | Betula nigra pollen .05 g/mL | Injection, SolutionSubcutaneous | ALK-Abello, Inc. | 0268-1063 | 00268-1063-1000268-1063-50 |
Other NDCs under BLA 103753
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 |
|---|---|---|---|---|
| 10 Tree Mixacer negundo pollen, betula nigra pollen, black walnut, carya ovata pollen, fraxinus americana pollen, platanus occidentalis pollen, populus deltoides subsp. monilifera pollen, quercus rubra pollen, salix nigra pollen and ulmus americana pollen | Fraxinus americana pollen .05 g/mL + 9 more ingredients | Injection, SolutionSubcutaneous | ALK-Abello, Inc. | 0268-8000 |
| 4 Weed Mixamaranthus retroflexus pollen, chenopodium album pollen, plantago lanceolata pollen, xanthium strumarium pollen | Xanthium strumarium pollen .05 g/mL + 3 more ingredients | Injection, SolutionSubcutaneous | ALK-Abello, Inc. | 0268-8002 |
| 4 Weed Mixamaranthus retroflexus pollen, chenopodium album pollen, plantago lanceolata pollen and xanthium strumarium pollen | Xanthium strumarium pollen 40000 [PNU]/mL + 3 more ingredients | Injection, SolutionSubcutaneous | ALK-Abello, Inc. | 0268-8003 |
| 9 Tree Mixacer saccharum pollen, alnus rhombifolia pollen, betula lenta pollen, carya ovata pollen, fraxinus americana pollen, platanus occidentalis pollen, populus alba pollen, quercus alba pollen and ulmus crassifolia pollen | Alnus rhombifolia pollen .05 g/mL + 8 more ingredients | Injection, SolutionPercutaneous | ALK-Abello, Inc. | 0268-8019 |
| 9 Tree Mixacer saccharinum pollen, alnus rhombifolia pollen, betula lenta whole, carya ovata pollen, fraxinus americana pollen, platanus occidentalis pollen, populus alba pollen, quercus alba pollen, ulmus americana pollen | Alnus rhombifolia pollen 40000 [PNU]/mL + 8 more ingredients | Injection, SolutionSubcutaneous | ALK-Abello, Inc. | 0268-8020 |
| 9 Tree Mixacer saccharinum pollen, alnus rhombifolia pollen, betula lenta whole, carya ovata pollen, fraxinus americana pollen, platanus occidentalis pollen, populus alba pollen, quercus alba pollen, ulmus crassifolia pollen | Alnus rhombifolia pollen .1 g/mL + 8 more ingredients | Injection, SolutionSubcutaneous | ALK-Abello, Inc. | 0268-8021 |
| 9 Tree Mixacer saccharum pollen, alnus rhombifolia pollen, betula lenta pollen, carya ovata pollen, fraxinus americana pollen, platanus occidentalis pollen, populus alba pollen, quercus alba pollen and ulmus crassifolia pollen | Alnus rhombifolia pollen .05 g/mL + 8 more ingredients | Injection, SolutionSubcutaneous | ALK-Abello, Inc. | 0268-8022 |
| Acacia | Acacia .05 g/mL | Injection, SolutionSubcutaneous | ALK-Abello, Inc. | 0268-1001 |
| Acacia | Acacia .05 g/mL | Injection, SolutionPercutaneous | ALK-Abello, Inc. | 0268-6600 |
| Acer Negundo Pollenbox elder ash leaf maple | Acer negundo pollen .1 g/mL | Injection, SolutionSubcutaneous | ALK-Abello, Inc. | 0268-1080 |
| Acer Negundo Pollenbox elder ash leaf maple | Acer negundo pollen .05 g/mL | Injection, SolutionSubcutaneous | ALK-Abello, Inc. | 0268-1081 |
| Acer Negundo Pollenbox elder ash leaf maple | Acer negundo pollen .05 g/mL | Injection, SolutionPercutaneous | ALK-Abello, Inc. | 0268-6612 |
| Acer Rubrum Pollenmaple red | Acer rubrum pollen .05 g/mL | Injection, SolutionSubcutaneous | ALK-Abello, Inc. | 0268-1249 |
| Acer Rubrum Pollenred maple | Acer rubrum pollen .05 g/mL | Injection, SolutionPercutaneous | ALK-Abello, Inc. | 0268-6634 |
| Acer Saccharum Pollenmaple sugar | Acer saccharum pollen .1 g/mL | Injection, SolutionSubcutaneous | ALK-Abello, Inc. | 0268-1252 |
| Acer Saccharum Pollenmaple sugar | Acer saccharum pollen 40000 [PNU]/mL | Injection, SolutionSubcutaneous | ALK-Abello, Inc. | 0268-1253 |
| Acer Saccharum Pollenmaple sugar | Acer saccharum pollen .05 g/mL | Injection, SolutionSubcutaneous | ALK-Abello, Inc. | 0268-1254 |
| Acer Saccharum Pollensugar maple | Acer saccharum pollen .05 g/mL | Injection, SolutionPercutaneous | ALK-Abello, Inc. | 0268-6635 |
| Almondprunus dulcis | Almond .1 g/mL | Injection, SolutionPercutaneous | ALK-Abello, Inc. | 0268-6100 |
| Alnus Incana Ssp Rugosa Pollenalder white | Alnus incana subsp. Rugosa pollen .1 g/mL | Injection, SolutionSubcutaneous | ALK-Abello, Inc. | 0268-1007 |
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