Non-standardized allergenic · BLA
Smut, Corn (Ustilago maydis) NDC 49643-122
Ustilago maydis .05 g/mL · Injection · Cutaneous, Intradermal, Subcutaneous · Allermed Laboratories, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49643-122-05 | 4964301220549643012205 | 5 mL in 1 VIAL, MULTI-DOSE (49643-122-05)Marketed from Mar 12, 1974 | |
| 49643-122-10 | 4964301221049643012210 | 10 mL in 1 VIAL, MULTI-DOSE (49643-122-10)Marketed from Mar 12, 1974 | |
| 49643-122-30 | 4964301223049643012230 | 30 mL in 1 VIAL, MULTI-DOSE (49643-122-30)Marketed from Mar 12, 1974 | |
| 49643-122-50 | 4964301225049643012250 | 50 mL in 1 VIAL, MULTI-DOSE (49643-122-50)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, Corn
- Generic name (nonproprietary)
- ustilago maydis
- Active ingredients
- Ustilago maydis — .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 49643-122_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
N449643012205followed by a unit qualifier and the quantityPackage 49643-0122-05. 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 49643-122
- What is NDC 49643-122?
- 49643-122 is the product NDC for Smut, Corn (ustilago maydis), Ustilago maydis .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, Corn (Ustilago maydis).
- What is the active ingredient?
- Ustilago maydis.
- 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, Corn?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
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 |
|---|---|---|---|---|
| Greasewood Pollensarcobatus vermiculatus | Sarcobatus vermiculatus pollen .05 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-411 |
| Arroyo Willow Pollensalix lasiolepsis | Salix lasiolepis pollen .05 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-408 |
| Black Willow Pollensalix nigra | Salix nigra pollen .05 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-409 |
| Russian Thistle Pollensalsola kali | Salsola kali pollen .05 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-410 |
| Pepper Tree Pollenschinus molle | Schinus molle pollen .05 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-412 |
| Johnson Grass Pollensorghum halepense | Sorghum halepense pollen .05 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-413 |
| Alkali Blite Pollensuaeda spp. | Suaeda nigra pollen .05 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-414 |
| Chinese Elm Pollenulmus pumila | Ulmus pumila pollen .05 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-419 |
| Salt Cedar Pollentamarix gallica | Tamarix gallica pollen .05 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-415 |
| Dandelion Pollentaraxacum officinale | Taraxacum officinale pollen .05 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-416 |
| American Elm Pollenulmus americana | Ulmus americana pollen .05 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-417 |
| Red Maple Pollenacer rubrum | Acer rubrum pollen .05 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-434 |
| Cocklebur Pollenxanthium commune | Xanthium strumarium pollen .05 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-420 |
| Corn Pollen Pollenzea mays | Zea mays pollen .05 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-422 |
| Nettle Pollenurtica dioica | Urtica dioica pollen .05 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-423 |
| Coast Sage Pollenartemisia californica | Artemisia californica pollen .05 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-437 |
| Red Alder Pollenalnus rubra | Alnus rubra pollen .05 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-435 |
| Tag Alder Pollenalnus rugosa | Alnus incana subsp. Rugosa pollen .05 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-436 |
| Spring Birch Pollenbetula fontinalis | Betula occidentalis pollen .05 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-441 |
| Wing Scale Pollenatriplex canescens | Atriplex canescens pollen .05 g/mL | InjectionCutaneous, Intradermal, Subcutaneous | Allermed Laboratories, Inc. | 49643-438 |
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