Prescription drug · BLA
Short Ragweed (ambrosia artemisiifolia) NDC 49643-315
Ambrosia artemisiifolia pollen 1 g/10mL · Injection · Cutaneous, Intradermal, Subcutaneous · Allermed Laboratories, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49643-315-05 | 49643031505 | 5 mL in 1 VIAL, MULTI-DOSE (49643-315-05)Marketed from Mar 22, 1982 | |
| 49643-315-10 | 49643031510 | 10 mL in 1 VIAL, MULTI-DOSE (49643-315-10)Marketed from Mar 22, 1982 | |
| 49643-315-30 | 49643031530 | 30 mL in 1 VIAL, MULTI-DOSE (49643-315-30)Marketed from Mar 22, 1982 | |
| 49643-315-50 | 49643031550 | 50 mL in 1 VIAL, MULTI-DOSE (49643-315-50)Marketed from Mar 22, 1982 |
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)
- Short Ragweed
- Generic name (nonproprietary)
- ambrosia artemisiifolia
- Active ingredients
- Ambrosia artemisiifolia pollen — 1 g/10mL
- Dosage form
- Injection
- Route
- Cutaneous, Intradermal, Subcutaneous
- Labeler
- Allermed Laboratories, Inc.
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 103113
- 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 49643-315_2beeb52f-4452-7e67-e063-6294a90a5477SPL ID 2beeb52f-4452-7e67-e063-6294a90a5477SPL set ID 1482f8a2-c2c0-45a1-8e90-b427227f0b28RxCUI 896140UNII K20Y81ACO3
- 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
N449643031505followed by a unit qualifier and the quantityPackage 49643-0315-05. 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS Studies have shown that properly performed an interpreted skin tests with ragweed pollen extract are useful in the diagnosis of allergy to ragweed pollen 7, 8, 20, 21 . Immunotherapy with the appropriate dosage of short ragweed pollen extract is effective in reducing symptoms of hay fever and asthma resulting from exposure to short ragweed pollen (9, 10, 11), and it is believed to be effective with extract of giant ragweed, although carefully controlled studies are unavailable. However, clinical observations and known cross reactivity between short and giant ragweed pollens have led to the practice of using a mixture of the two species for skin testing and treatment 22, 23, 24, 2…
Excerpt only. Read the full label for complete information.