Non-standardized allergenic · BLA
Aspen Pollen (Populus tremuloides) NDC 49643-398
Populus tremuloides pollen .05 g/mL · Injection · Cutaneous, Intradermal, Subcutaneous · Allermed Laboratories, Inc.
NDC codes
FDA NDC DirectoryProduct NDC (as listed)49643-398Labeler and product segments. Claims need a package NDC.
Product NDC at billing width49643-0398Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49643-398-05 | 4964303980549643039805 | 5 mL in 1 VIAL, MULTI-DOSE (49643-398-05)Marketed from Mar 12, 1974 | |
| 49643-398-10 | 4964303981049643039810 | 10 mL in 1 VIAL, MULTI-DOSE (49643-398-10)Marketed from Mar 12, 1974 | |
| 49643-398-30 | 4964303983049643039830 | 30 mL in 1 VIAL, MULTI-DOSE (49643-398-30)Marketed from Mar 12, 1974 | |
| 49643-398-50 | 4964303985049643039850 | 50 mL in 1 VIAL, MULTI-DOSE (49643-398-50)Marketed from Mar 12, 1974 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Aspen Pollen
- Generic name (nonproprietary)
- populus tremuloides
- Active ingredients
- Populus tremuloides pollen — .05 g/mL
- Dosage form
- Injection
- Route
- Cutaneous, Intradermal, Subcutaneous
- Labeler
- Allermed Laboratories, Inc.NDC labeler code 49643
- Product type
- Non-standardized allergenic
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 102211
- 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 49643-398_36ad1e17-751d-e226-e063-6394a90ab328SPL ID 36ad1e17-751d-e226-e063-6394a90ab328
- 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.
- 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
N449643039805followed by a unit qualifier and the quantityPackage 49643-0398-05. 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 49643-398
- What is NDC 49643-398?
- 49643-398 is the product NDC for Aspen Pollen (populus tremuloides), Populus tremuloides pollen .05 g/mL injection, listed with the FDA by Allermed Laboratories, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Aspen Pollen (Populus tremuloides).
- What is the active ingredient?
- Populus tremuloides pollen.
- Who is the labeler?
- Allermed Laboratories, Inc., NDC labeler code 49643. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Aspen Pollen?
- 5 other product NDCs are listed under this name. See all Aspen Pollen NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Aspen 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) |
|---|---|---|---|---|---|
| Aspen Pollenpopulus tremuloides | Populus tremuloides pollen .1 g/mL | SolutionIntradermal, Percutaneous, Subcutaneous | Greer Laboratories, Inc. | 22840-1430 | 22840-1430-0222840-1430-04 |
| Aspen Pollenpopulus tremuloides | Populus tremuloides pollen .001 g/mL | SolutionIntradermal, Percutaneous, Subcutaneous | Greer Laboratories, Inc. | 22840-1431 | 22840-1431-01 |
| Aspen Pollenpopulus tremuloides | Populus tremuloides pollen 20000 [PNU]/mL | SolutionIntradermal, Percutaneous, Subcutaneous | Greer Laboratories, Inc. | 22840-4431 | 22840-4431-02 |
| Aspen Pollenpopulus tremuloides | Populus tremuloides pollen .05 g/mL | SolutionIntradermal, Percutaneous, Subcutaneous | Greer Laboratories, Inc. | 22840-4432 | 22840-4432-02 |
| Aspen Pollenpopulus tremuloides | Populus tremuloides pollen .05 g/mL | SolutionIntradermal, Percutaneous, Subcutaneous | Greer Laboratories, Inc. | 22840-5408 | 22840-5408-0222840-5408-0422840-5408-05 |
Other NDCs under BLA 102211
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 |
|---|---|---|---|---|
| Canyon Ragweed Pollenambrosia ambrosioides | Ambrosia ambrosioides pollen .05 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-352 |
| Sandbur Ragweed Pollenambrosia bipinnatifida | Ambrosia chamissonis pollen .05 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-353 |
| Rabbitbush Pollenambrosia deltoides | Ambrosia deltoidea pollen .05 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-354 |
| Desert Ragweed Pollenambrosia dumosa | Ambrosia dumosa pollen .05 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-355 |
| Redroot Pigweed Pollenamaranthus retroflexus | Amaranthus retroflexus pollen .05 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-314 |
| Western Ragweed Pollenambrosia psilostachia | Ambrosia psilostachya pollen .05 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-316 |
| Giant Ragweed Pollenambrosia trifida | Ambrosia trifida pollen .05 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-317 |
| Wormwood Sage Pollenartemisia absinthium | Artemisia absinthium pollen .05 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-319 |
| Common Sage Pollenartemisia tridentata | Artemisia tridentata pollen .05 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-320 |
| Mugwort Sage Pollenartemisia vulgaris | Artemisia vulgaris pollen .05 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-321 |
| Cultivated Oat Pollenavena sativa | Avena sativa pollen .05 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-322 |
| Bassia Pollenbassia hyssopifolia | Bassia hyssopifolia pollen .05 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-323 |
| Sugar Beet Pollenbeta vulgaris | Beta vulgaris pollen .05 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-324 |
| Gray (White) Birch Pollenbetula populifolia | Betula populifolia pollen .05 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-325 |
| Grama grass Pollenbouteloua spp. | Bouteloua gracilis pollen .05 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-326 |
| Mustard Pollenbrassica campestris | Brassica rapa pollen .05 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-327 |
| Smooth Brome Pollenbromus inermis | Bromus inermis pollen .05 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-328 |
| Cheat Grass Pollenbromus secalinus | Bromus secalinus pollen .05 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-329 |
| Bottlebrush Pollencallistemon citrinus | Callistemon citrinus pollen .05 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-330 |
| Shagbark Hickory Pollencarya ovata | Carya ovata pollen .05 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-332 |
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