Non-standardized allergenic · BLA
Smut, Wheat (Tilletia caries (tritici)) NDC 49643-124
Tilletia caries .05 g/mL · Injection · Cutaneous, Intradermal, Subcutaneous · Allermed Laboratories, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49643-124-05 | 49643012405 | 5 mL in 1 VIAL, MULTI-DOSE (49643-124-05)Marketed from Mar 12, 1974 | |
| 49643-124-10 | 49643012410 | 10 mL in 1 VIAL, MULTI-DOSE (49643-124-10)Marketed from Mar 12, 1974 | |
| 49643-124-30 | 49643012430 | 30 mL in 1 VIAL, MULTI-DOSE (49643-124-30)Marketed from Mar 12, 1974 | |
| 49643-124-50 | 49643012450 | 50 mL in 1 VIAL, MULTI-DOSE (49643-124-50)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)
- Smut, Wheat
- Generic name (nonproprietary)
- tilletia caries (tritici)
- Active ingredients
- Tilletia caries — .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)Fungal Proteins (Chemical structure)Increased Histamine Release (Physiologic effect)Increased IgG Production (Physiologic effect)
- Identifiers
- Product ID 49643-124_36ad1e17-751d-e226-e063-6394a90ab328SPL ID 36ad1e17-751d-e226-e063-6394a90ab328
- Pharmacologic class
- Non-Standardized Fungal 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
N449643012405followed by a unit qualifier and the quantityPackage 49643-0124-05. 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 49643-124
- What is NDC 49643-124?
- 49643-124 is the product NDC for Smut, Wheat (tilletia caries (tritici)), Tilletia caries .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?
- Smut, Wheat (Tilletia caries (tritici)).
- What is the active ingredient?
- Tilletia caries.
- 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 Smut, Wheat?
- 1 other product NDC are listed under this name. See all Smut, Wheat NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Smut, Wheat products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Smut, Wheatustilago tritici | Ustilago tritici .033 g/mL | LiquidPercutaneous, Subcutaneous | Allermed Laboratories, Inc. | 49643-177 | 49643-0177-0549643-0177-1049643-0177-30+1 more |
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 |
|---|---|---|---|---|
| Acacia Pollenacacia spp. | Acacia pollen .05 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-301 |
| Alder Mixalnus rhombifolia/alnus rubra/alnus rugosa | Alnus rhombifolia pollen .0167 g/mL + 2 more ingredients | LiquidPercutaneous, Subcutaneous | Allermed Laboratories, Inc. | 49643-501 |
| Alder, White Pollenalnus rhombifolia | Alnus rhombifolia pollen .05 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-312 |
| Alfalfa Pollenmedicago sativa | Medicago sativa pollen .02 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-300 |
| Alkali Blite Pollensuaeda spp. | Suaeda nigra pollen .05 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-414 |
| Alternariaalternaria alternata | Alternaria alternata .1 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-101 |
| American Elm Pollenulmus americana | Ulmus americana pollen .05 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-417 |
| Arizona Ash Pollenfraxinus velutina | Fraxinus velutina pollen .05 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-359 |
| Arroyo Willow Pollensalix lasiolepsis | Salix lasiolepis pollen .05 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-408 |
| Aspen Pollenpopulus tremuloides | Populus tremuloides pollen .05 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-398 |
| Aspergillus fumigatus | Aspergillus fumigatus .1 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-130 |
| Aspergillus nidulans | Aspergillus nidulans .1 g/mL | LiquidPercutaneous, Subcutaneous | Allermed Laboratories, Inc. | 49643-161 |
| Aspergillus niger | Aspergillus niger var. Niger .1 g/mL | LiquidPercutaneous, Subcutaneous | Allermed Laboratories, Inc. | 49643-162 |
| Australian Pine Pollencasuarina equisetifoli | Casuarina equisetifolia pollen .05 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-335 |
| Bahia Grass Pollenpaspalum notatum | Paspalum notatum pollen .05 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-384 |
| Bassia Pollenbassia hyssopifolia | Bassia hyssopifolia pollen .05 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-323 |
| Beech Pollenfagus grandifolia | Fagus grandifolia pollen .05 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-349 |
| Black Cottonwood Pollenpopulus trichocarpa | Populus trichocarpa pollen .05 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-399 |
| Black Oak Pollenquercus velutina | Quercus velutina pollen .05 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-451 |
| Black Walnut Pollenjuglans nigra | Juglans nigra pollen .05 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-366 |
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