Standardized allergenic · BLA
Standardized Grass Pollen, Bluegrass, Kentucky June NDC 65044-0546
Poa pratensis pollen 100000 [BAU]/mL · Injection, Solution · Percutaneous, Subcutaneous · Jubilant HollisterStier LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65044-0546-1 | 65044054601 | 5 mL in 1 VIAL (65044-0546-1)Marketed from Jan 15, 1998 | |
| 65044-0546-2 | 65044054602 | 10 mL in 1 VIAL (65044-0546-2)Marketed from Jan 15, 1998 | |
| 65044-0546-3 | 65044054603 | 30 mL in 1 VIAL (65044-0546-3)Marketed from Jan 15, 1998 | |
| 65044-0546-4 | 65044054604 | 50 mL in 1 VIAL (65044-0546-4)Marketed from Jan 15, 1998 |
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)
- Standardized Grass Pollen, Bluegrass, Kentucky June
- Generic name (nonproprietary)
- standardized grass pollen, bluegrass, kentucky june
- Active ingredients
- Poa pratensis pollen — 100000 [BAU]/mL
- Dosage form
- Injection, Solution
- Route
- Percutaneous, Subcutaneous
- Labeler
- Jubilant HollisterStier LLCNDC labeler code 65044
- Product type
- Standardized allergenic
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 103873
- 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 65044-0546_3c14e8ca-64c9-463f-963d-5a2e31d01ad3SPL ID 3c14e8ca-64c9-463f-963d-5a2e31d01ad3
- 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
N465044054601followed by a unit qualifier and the quantityPackage 65044-0546-01. 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 65044-0546
- What is NDC 65044-0546?
- 65044-0546 is the product NDC for Standardized Grass Pollen, Bluegrass, Kentucky June, Poa pratensis pollen 100000 [BAU]/mL injection, solution, listed with the FDA by Jubilant HollisterStier LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Standardized Grass Pollen, Bluegrass, Kentucky June.
- What is the active ingredient?
- Poa pratensis 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 Standardized Grass Pollen, Bluegrass, Kentucky June?
- 1 other product NDC are listed under this name. See all Standardized Grass Pollen, Bluegrass, Kentucky June NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Standardized Grass Pollen, Bluegrass, Kentucky June products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Standardized Grass Pollen, Bluegrass, Kentucky June | Poa pratensis pollen 10000 [BAU]/mL | Injection, SolutionPercutaneous, Subcutaneous | Jubilant HollisterStier LLC | 65044-0545 | 65044-0545-0165044-0545-0265044-0545-03+1 more |
Other NDCs under BLA 103873
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 |
|---|---|---|---|---|
| Standardized Grass Pollen, Bluegrass, Kentucky June | Poa pratensis pollen 10000 [BAU]/mL | Injection, SolutionPercutaneous, Subcutaneous | Jubilant HollisterStier LLC | 65044-0545 |
| Standardized Grass Pollen, Grass Mix 4 | Poa pratensis pollen 25000 [BAU]/mL + 3 more ingredients | Injection, SolutionPercutaneous, Subcutaneous | Jubilant HollisterStier LLC | 65044-0842 |