Standardized allergenic · BLA
Standardized Mite Mix, Dermatophagoides pteronyssinus and Dermatophagoides farinae, 10000 AU per mL NDC 65044-6691
Dermatophagoides farinae 5000 [AU]/mL; Dermatophagoides pteronyssinus 5000 [AU]/mL · Injection, Solution · Subcutaneous · Jubilant HollisterStier LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65044-6691-2 | 65044669102 | 10 mL in 1 VIAL (65044-6691-2)Marketed from May 26, 1988 | |
| 65044-6691-3 | 65044669103 | 30 mL in 1 VIAL (65044-6691-3)Marketed from May 26, 1988 | |
| 65044-6691-4 | 65044669104 | 50 mL in 1 VIAL (65044-6691-4)Marketed from May 26, 1988 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Standardized Mite Mix, Dermatophagoides pteronyssinus and Dermatophagoides farinae, 10000 AU per mL
- Generic name (nonproprietary)
- standardized mite mix, dermatophagoides pteronyssinus and dermatophagoides farinae, 10000 au per ml
- Active ingredients
- Dermatophagoides farinae — 5000 [AU]/mLDermatophagoides pteronyssinus — 5000 [AU]/mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- Jubilant HollisterStier LLCNDC labeler code 65044
- Product type
- Standardized allergenic
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 103870
- Marketing start
- Listing expires
- Other FDA classes
- Allergens (Chemical structure)Allergens (Chemical structure)Dermatophagoides (Chemical structure)Dermatophagoides (Chemical structure)Cell-mediated Immunity (Physiologic effect)Cell-mediated Immunity (Physiologic effect)Increased Histamine Release (Physiologic effect)Increased Histamine Release (Physiologic effect)Increased IgG Production (Physiologic effect)Increased IgG Production (Physiologic effect)Insect Proteins (Chemical structure)Insect Proteins (Chemical structure)
- Identifiers
- Product ID 65044-6691_c0f7a73d-257f-46e9-b52d-ec3758576b4bSPL ID c0f7a73d-257f-46e9-b52d-ec3758576b4b
- 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
N465044669102followed by a unit qualifier and the quantityPackage 65044-6691-02. 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 65044-6691
- What is NDC 65044-6691?
- 65044-6691 is the product NDC for Standardized Mite Mix, Dermatophagoides pteronyssinus and Dermatophagoides farinae, 10000 AU per mL, Dermatophagoides farinae 5000 [AU]/mL; Dermatophagoides pteronyssinus 5000 [AU]/mL injection, solution, listed with the FDA by Jubilant HollisterStier LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Standardized Mite Mix, Dermatophagoides pteronyssinus and Dermatophagoides farinae, 10000 AU per mL.
- What is the active ingredient?
- Dermatophagoides farinae, Dermatophagoides pteronyssinus.
- Who is the labeler?
- Jubilant HollisterStier LLC, NDC labeler code 65044. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Standardized Mite Mix, Dermatophagoides pteronyssinus and Dermatophagoides farinae, 10000 AU per mL?
- 1 other product NDC are listed under this name. See all Standardized Mite Mix, Dermatophagoides pteronyssinus and Dermatophagoides farinae, 10000 AU per mL NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Standardized Mite Mix, Dermatophagoides pteronyssinus and Dermatophagoides farinae, 10000 AU per mL products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Standardized Mite Mix, Dermatophagoides pteronyssinus and Dermatophagoides farinae, 30000 AU per mL | Dermatophagoides farinae 15000 [AU]/mL; Dermatophagoides pteronyssinus 15000 [AU]/mL | Injection, SolutionSubcutaneous | Jubilant HollisterStier LLC | 65044-6690 | 65044-6690-0265044-6690-03 |
Other NDCs under BLA 103870
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 |
|---|---|---|---|---|
| Standardized Mite Mix, Dermatophagoides pteronyssinus and Dermatophagoides farinae, 30000 AU per mL | Dermatophagoides farinae 15000 [AU]/mL; Dermatophagoides pteronyssinus 15000 [AU]/mL | Injection, SolutionSubcutaneous | Jubilant HollisterStier LLC | 65044-6690 |
| Standardized Mite, Dermatophagoides farinae, Scratch or Bulk, 30000 AU per mL | Dermatophagoides farinae 30000 [AU]/mL | Injection, SolutionPercutaneous, Subcutaneous | Jubilant HollisterStier LLC | 65044-6720 |
| Standardized Mite, Dermatophagoides farinae, Bulk, 10000 AU per mL | Dermatophagoides farinae 10000 [AU]/mL | Injection, SolutionSubcutaneous | Jubilant HollisterStier LLC | 65044-6723 |