Prescription drug · BLA
House Dust Mite, Dermatophagoides farinae NDC 49643-702
Dermatophagoides farinae 10000 [AU]/mL · Injection · Cutaneous, Intradermal, Subcutaneous · Allermed Laboratories, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49643-702-05 | 49643070205 | 5 mL in 1 VIAL, MULTI-DOSE (49643-702-05)Marketed from Dec 24, 1986 | |
| 49643-702-10 | 49643070210 | 10 mL in 1 VIAL, MULTI-DOSE (49643-702-10)Marketed from Dec 24, 1986 | |
| 49643-702-30 | 49643070230 | 30 mL in 1 VIAL, MULTI-DOSE (49643-702-30)Marketed from Dec 24, 1986 | |
| 49643-702-50 | 49643070250 | 50 mL in 1 VIAL, MULTI-DOSE (49643-702-50)Marketed from Dec 24, 1986 |
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)
- House Dust Mite, Dermatophagoides farinae
- Generic name (nonproprietary)
- house dust mite, dermatophagoides farinae
- Active ingredients
- Dermatophagoides farinae — 10000 [AU]/mL
- Dosage form
- Injection
- Route
- Cutaneous, Intradermal, Subcutaneous
- Labeler
- Allermed Laboratories, Inc.
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 102212
- Marketing start
- Listing expires
- Other FDA classes
- Allergens (Chemical structure)Dermatophagoides (Chemical structure)Cell-mediated Immunity (Physiologic effect)Increased Histamine Release (Physiologic effect)Increased IgG Production (Physiologic effect)Insect Proteins (Chemical structure)
- Identifiers
- Product ID 49643-702_36ad59b6-cc4b-fe11-e063-6394a90ac650SPL ID 36ad59b6-cc4b-fe11-e063-6394a90ac650SPL set ID 3b19e1e4-1a28-4515-ac20-cc4a9b2d45e6RxCUI 852825, 852829UNII 57L1Z5378K, PR9U2YPF3Q
- Pharmacologic class
- Standardized Insect 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
N449643070205followed by a unit qualifier and the quantityPackage 49643-0702-05. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Standardized mite extract is indicated for use in the diagnosis of patients with a history of allergy to mites or house dust and for the treatment of patients with a history of mite allergy who have established sensitivity to mites by diagnostic skin testing. The use of mite extract for the above purposes should be made only by physicians with special familiarity and knowledge of allergy as described in a standard allergy textbook (10).
Excerpt only. Read the full label for complete information.