Prescription drug · BLA
Standardized Mite Dermatophagoides pteronyssinus NDC 22840-0035
dermatophagoides pteronyssinus · Dermatophagoides pteronyssinus 5000 [AU]/mL · Concentrate · Intradermal, Percutaneous, Subcutaneous · Greer Laboratories, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 22840-0035-6 | 22840003506 | 10 mL in 1 VIAL, MULTI-DOSE (22840-0035-6)Marketed from Jun 27, 1989 | |
| 22840-0035-9 | 22840003509 | 50 mL in 1 VIAL, MULTI-DOSE (22840-0035-9)Marketed from Jun 27, 1989 |
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 Dermatophagoides pteronyssinus
- Generic name (nonproprietary)
- dermatophagoides pteronyssinus
- Active ingredients
- Dermatophagoides pteronyssinus — 5000 [AU]/mL
- Dosage form
- Concentrate
- Route
- Intradermal, Percutaneous, Subcutaneous
- Labeler
- Greer Laboratories, Inc.
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 101835
- 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 22840-0035_2d7b99ba-afb8-40cd-e063-6294a90a789dSPL ID 2d7b99ba-afb8-40cd-e063-6294a90a789dSPL set ID 9b7f878e-613f-4831-9223-a6a07fb09f1bRxCUI 852813, 852825, 852829, 854052, 854068, 1014384, 1192787UNII 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
N422840003506followed by a unit qualifier and the quantityPackage 22840-0035-06. 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)
Greer Standardized Mite ( Dermatophagoides farinae and/or Dermatophagoides pteronyssinus ) Extracts are allergenic extracts indicated for: skin test diagnosis of mite allergy treatment of patients with mite-induced allergic asthma, rhinitis and conjunctivitis. For immunotherapy, patients must show hypersensitivity to Dermatophagoides farinae ( D. farinae ) or Dermatophagoides pteronyssinus ( D. pteronyssinus ) based on their clinical history, allergen exposure history, and skin test reactivity. Greer Standardized Mite Extracts are allergenic extracts indicated for: Diagnosis of skin test reactivity to dust mite allergen (1) Treatment of mite-induced allergic asthma, rhinitis and conjunctivit…
Excerpt only. Read the full label for complete information.
Other NDCs under BLA 101835
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 Dermatophagoides pteronyssinusdermatophagoides pteronyssinus | Dermatophagoides pteronyssinus 30000 [AU]/mL | ConcentrateIntradermal, Percutaneous, Subcutaneous | Greer Laboratories, Inc. | 22840-0039 |
| Standardized Mite Dermatophagoides pteronyssinusdermatophagoides pteronyssinus | Dermatophagoides pteronyssinus 10000 [AU]/mL | ConcentrateIntradermal, Percutaneous, Subcutaneous | Greer Laboratories, Inc. | 22840-0036 |