Non-standardized allergenic · BLA
White Oak Pollen (Quercus alba) NDC 49643-402
Quercus alba pollen .05 g/mL · Injection · Cutaneous, Intradermal, Subcutaneous · Allermed Laboratories, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49643-402-05 | 49643040205 | 5 mL in 1 VIAL, MULTI-DOSE (49643-402-05)Marketed from Mar 12, 1974 | |
| 49643-402-10 | 49643040210 | 10 mL in 1 VIAL, MULTI-DOSE (49643-402-10)Marketed from Mar 12, 1974 | |
| 49643-402-30 | 49643040230 | 30 mL in 1 VIAL, MULTI-DOSE (49643-402-30)Marketed from Mar 12, 1974 | |
| 49643-402-50 | 49643040250 | 50 mL in 1 VIAL, MULTI-DOSE (49643-402-50)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)
- White Oak Pollen
- Generic name (nonproprietary)
- quercus alba
- Active ingredients
- Quercus alba 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 49643-402_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
N449643040205followed by a unit qualifier and the quantityPackage 49643-0402-05. 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 49643-402
- What is NDC 49643-402?
- 49643-402 is the product NDC for White Oak Pollen (quercus alba), Quercus alba 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?
- White Oak Pollen (Quercus alba).
- What is the active ingredient?
- Quercus alba 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 White Oak Pollen?
- 6 other product NDCs are listed under this name. See all White Oak Pollen NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other White Oak 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) |
|---|---|---|---|---|---|
| White Oak Pollenquercus alba | Quercus alba pollen .05 g/mL | SolutionIntradermal, Percutaneous, Subcutaneous | Greer Laboratories, Inc. | 22840-3410 | 22840-3410-0222840-3410-04 |
| White Oak Pollenquercus alba | Quercus alba pollen .1 g/mL | SolutionIntradermal, Percutaneous, Subcutaneous | Greer Laboratories, Inc. | 22840-3408 | 22840-3408-0222840-3408-04 |
| White Oak Pollenquercus alba | Quercus alba pollen 20000 [PNU]/mL | SolutionIntradermal, Percutaneous, Subcutaneous | Greer Laboratories, Inc. | 22840-3409 | 22840-3409-0222840-3409-04 |
| White Oak Pollenquercus alba | Quercus alba pollen 40000 [PNU]/mL | SolutionIntradermal, Percutaneous, Subcutaneous | Greer Laboratories, Inc. | 22840-3411 | 22840-3411-0222840-3411-04 |
| White Oak Pollenquercus alba | Quercus alba pollen .001 g/mL | SolutionIntradermal, Percutaneous, Subcutaneous | Greer Laboratories, Inc. | 22840-3412 | 22840-3412-01 |
| White Oak Pollenquercus alba | Quercus alba pollen .05 g/mL | SolutionIntradermal, Percutaneous, Subcutaneous | Greer Laboratories, Inc. | 22840-5482 | 22840-5482-0222840-5482-0422840-5482-05 |
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 |
|---|---|---|---|---|
| Yellow Pine Pollenpinus ponderosa | Pinus ponderosa pollen .05 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-449 |
| Red Mulberry Pollenmorus rubra | Morus rubra pollen .05 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-447 |
| Shortleaf Pine Pollenpinus echinata | Pinus echinata pollen .05 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-448 |
| Linden Pollentilia cordata | Tilia cordata pollen .05 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-460 |
| Red Oak Pollenquercus rubra | Quercus rubra pollen .05 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-450 |
| Black Oak Pollenquercus velutina | Quercus velutina pollen .05 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-451 |
| Hard Maple Pollenacer saccharum | Acer saccharum pollen .05 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-452 |
| Alder Mixalnus rhombifolia/alnus rubra/alnus rugosa | Alnus rhombifolia pollen .0167 g/mL + 2 more ingredients | LiquidPercutaneous, Subcutaneous | Allermed Laboratories, Inc. | 49643-501 |
| Maple, California Mixacer macrophyllum/acer negundo | Acer negundo pollen .025 g/mL; Acer macrophyllum pollen .025 g/mL | LiquidPercutaneous, Subcutaneous | Allermed Laboratories, Inc. | 49643-520 |
| Pine Mixpinus echinata/pinus ponderosa/pinus strobus | Pinus echinata pollen .0167 g/mL + 2 more ingredients | LiquidPercutaneous, Subcutaneous | Allermed Laboratories, Inc. | 49643-524 |
| Walnut Mix | Juglans nigra pollen .0167 g/mL + 2 more ingredients | InjectionPercutaneous, Subcutaneous | Allermed Laboratories, Inc. | 49643-544 |
| Trichophyton Mixtrichophyton mentagrophytes/trichophyton rubrum | Trichophyton rubrum .005 g/mL; Trichophyton mentagrophytes .0005 g/mL | LiquidPercutaneous, Subcutaneous | Allermed Laboratories, Inc. | 49643-802 |
| Glycerol-Saline Controlglycerol-saline diluent | Glycerin .53 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-818 |
| Cottonseed | Cotton seed .1 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-005 |
| Cattle Epithelia | Bos taurus skin .1 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-003 |
| Cotton Linters | Cotton fiber .1 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-004 |
| House Dust | House dust .02 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-008 |
| Dog Hair | Canis lupus familiaris hair .1 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-006 |
| Hamster Epithelia | Mesocricetus auratus skin .05 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-013 |
| Flaxseed | Flax seed .05 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-010 |
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