Non-standardized allergenic · BLA
Pollens - Trees, Birch Mix (Birch mix) NDC 65044-1169
Betula papyrifera pollen .05 g/mL + 2 more ingredients · Injection, Solution · Percutaneous · Jubilant HollisterStier LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)65044-1169Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65044-1169Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65044-1169-1 | 65044116901 | 5 mL in 1 VIAL (65044-1169-1)Marketed from Apr 19, 1941 |
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)
- Pollens - Trees, Birch Mix
- Generic name (nonproprietary)
- birch mix
- Active ingredients
- Betula papyrifera pollen — .05 g/mLBetula pendula pollen — .05 g/mLBetula nigra pollen — .05 g/mL
- Dosage form
- Injection, Solution
- Route
- Percutaneous
- Labeler
- Jubilant HollisterStier LLCNDC labeler code 65044
- Product type
- Non-standardized allergenic
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 103888
- Marketing start
- Listing expires
- Other FDA classes
- Allergens (Chemical structure)Allergens (Chemical structure)Allergens (Chemical structure)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 IgG Production (Physiologic effect)Increased IgG Production (Physiologic effect)Increased IgG Production (Physiologic effect)Pollen (Chemical structure)Pollen (Chemical structure)Pollen (Chemical structure)
- Identifiers
- Product ID 65044-1169_d6fcbcef-b35a-48a4-968c-6da0f3817dbeSPL ID d6fcbcef-b35a-48a4-968c-6da0f3817dbe
- 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
N465044116901followed by a unit qualifier and the quantityPackage 65044-1169-01. 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 65044-1169
- What is NDC 65044-1169?
- 65044-1169 is the product NDC for Pollens - Trees, Birch Mix (birch mix), Betula papyrifera pollen .05 g/mL + 2 more ingredients injection, solution, listed with the FDA by Jubilant HollisterStier LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pollens - Trees, Birch Mix (Birch Mix).
- What is the active ingredient?
- Betula papyrifera pollen, Betula pendula pollen, Betula nigra pollen.
- Who is the labeler?
- Jubilant HollisterStier LLC, NDC labeler code 65044. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Pollens - Trees, Birch Mix?
- 3 other product NDCs are listed under this name. See all Pollens - Trees, Birch Mix NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Pollens - Trees, Birch Mix products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Pollens - Trees, Birch Mixbirch mix | Betula papyrifera pollen .05 g/mL + 2 more ingredients | Injection, SolutionPercutaneous, Subcutaneous | Jubilant HollisterStier LLC | 65044-1168 | 65044-1168-0265044-1168-0365044-1168-04 |
| Pollens - Trees, Birch Mixbirch mix | Betula papyrifera pollen .1 g/mL + 2 more ingredients | Injection, SolutionPercutaneous, Subcutaneous | Jubilant HollisterStier LLC | 65044-1171 | 65044-1171-0265044-1171-0365044-1171-04 |
| Pollens - Trees, Birch Mixbirch mix | Betula papyrifera pollen 20000 [PNU]/mL + 2 more ingredients | Injection, SolutionPercutaneous, Subcutaneous | Jubilant HollisterStier LLC | 65044-1172 | 65044-1172-0265044-1172-0365044-1172-04 |
Other NDCs under BLA 103888
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 |
|---|---|---|---|---|
| Pollens - Trees, Pine Mixpine mix | Pinus contorta pollen .05 g/mL; Pinus ponderosa pollen .05 g/mL | Injection, SolutionPercutaneous, Subcutaneous | Jubilant HollisterStier LLC | 65044-2203 |
| Pollens - Trees, Pepper Tree, California Schinus mollepepper tree, california schinus molle | Schinus molle pollen .05 g/mL | Injection, SolutionPercutaneous | Jubilant HollisterStier LLC | 65044-2108 |
| Pollens - Weeds and Garden Plants, Pigweed, Rough Redroot Amaranthus retroflexuspigweed, rough redroot amaranthus retroflexus | Amaranthus retroflexus pollen .05 g/mL | Injection, SolutionPercutaneous, Subcutaneous | Jubilant HollisterStier LLC | 65044-2125 |
| Pollens - Weeds and Garden Plants, Pigweed, Rough Redroot Amaranthus retroflexuspigweed, rough redroot amaranthus retroflexus | Amaranthus retroflexus pollen .05 g/mL | Injection, SolutionPercutaneous | Jubilant HollisterStier LLC | 65044-2126 |
| Pollens - Weeds, Marshelder/Poverty Mix | Iva axillaris pollen .05 g/mL + 2 more ingredients | Injection, SolutionPercutaneous, Subcutaneous | Jubilant HollisterStier LLC | 65044-1858 |
| Pollens - Trees, Maple, Hard Acer saccharummaple, hard acer saccharum | Acer saccharum pollen .05 g/mL | Injection, SolutionPercutaneous | Jubilant HollisterStier LLC | 65044-1832 |
| Pollens - Trees, Melaleuca Punk Tree Melaleuca quinquenerviamelaleuca, melaleuca quinquenervia | Melaleuca quinquenervia pollen .05 g/mL | Injection, SolutionPercutaneous | Jubilant HollisterStier LLC | 65044-1874 |
| Pollens - Weeds, Marshelder/Poverty Mix | Iva axillaris pollen .05 g/mL + 2 more ingredients | Injection, SolutionPercutaneous | Jubilant HollisterStier LLC | 65044-1859 |
| Pollens - Weeds, Marshelder/Poverty Mix | Iva axillaris pollen .1 g/mL + 2 more ingredients | Injection, SolutionPercutaneous, Subcutaneous | Jubilant HollisterStier LLC | 65044-1861 |
| Pollens - Trees, Melaleuca Punk Tree Melaleuca quinquenerviamelaleuca punk tree melaleuca quinquenervia | Melaleuca quinquenervia pollen .05 g/mL | Injection, SolutionPercutaneous, Subcutaneous | Jubilant HollisterStier LLC | 65044-1873 |
| Pollens - Trees, Mulberry Mixmulberry mix | Morus alba pollen .05 g/mL; Morus rubra pollen .05 g/mL | Injection, SolutionPercutaneous | Jubilant HollisterStier LLC | 65044-1910 |
| Pollens - Trees, Mesquite, Prosopis julifloramesquite, prosopis juliflora | Prosopis juliflora pollen .05 g/mL | Injection, SolutionPercutaneous, Subcutaneous | Jubilant HollisterStier LLC | 65044-1876 |
| Pollens - Trees, Mesquite, Prosopis julifloramesquite, prosopis juliflora | Prosopis juliflora pollen .05 g/mL | Injection, SolutionPercutaneous | Jubilant HollisterStier LLC | 65044-1877 |
| Pollens - Trees, Mulberry Mixmulberry mix | Morus alba pollen .05 g/mL; Morus rubra pollen .05 g/mL | Injection, SolutionPercutaneous, Subcutaneous | Jubilant HollisterStier LLC | 65044-1909 |
| Pollens - Weeds and Garden Plants, Nettle Urtica dioicanettle urtica dioica | Urtica dioica pollen .05 g/mL | Injection, SolutionPercutaneous | Jubilant HollisterStier LLC | 65044-1946 |
| Pollens - Trees, Mulberry Mixmulberry mix | Morus alba pollen .1 g/mL; Morus rubra pollen .1 g/mL | Injection, SolutionPercutaneous, Subcutaneous | Jubilant HollisterStier LLC | 65044-1912 |
| Pollens - Weeds and Garden Plants, Nettle Urtica dioicanettle urtica dioica | Urtica dioica pollen .05 g/mL | Injection, SolutionPercutaneous, Subcutaneous | Jubilant HollisterStier LLC | 65044-1945 |
| Pollens - Trees, Palo Verde Cercidium floridumpalo verde cercidium floridum | Parkinsonia florida pollen .05 g/mL | Injection, SolutionPercutaneous | Jubilant HollisterStier LLC | 65044-2017 |
| Pollens - Weeds and Garden Plants, Nettle Urtica dioicanettle urtica dioica | Urtica dioica pollen .1 g/mL | Injection, SolutionPercutaneous, Subcutaneous | Jubilant HollisterStier LLC | 65044-1947 |
| Pollens - Trees, Oak, Red Quercus rubraoak, red quercus rubra | Quercus rubra pollen .05 g/mL | Injection, SolutionPercutaneous, Subcutaneous | Jubilant HollisterStier LLC | 65044-2014 |
Showing 20 of 40.