Standardized allergenic · BLA
Odactra NDC 52709-1701
dermatophagoides pteronyssinus and dermatophagoides farinae · Dermatophagoides pteronyssinus 6 [arb'U]/1; Dermatophagoides farinae 6 [arb'U]/1 · Tablet · Sublingual · ALK-Abello A S
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 52709-1701-3 | 52709170103 | 3 BLISTER PACK in 1 CARTON (52709-1701-3) / 10 TABLET in 1 BLISTER PACK (52709-1701-1)Marketed from Jan 1, 2018 | |
| 52709-1701-5 | 52709170105 | 1 BLISTER PACK in 1 CARTON (52709-1701-5) / 5 TABLET in 1 BLISTER PACKMarketed from Jan 1, 2018 |
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)
- Odactra
- Generic name (nonproprietary)
- dermatophagoides pteronyssinus and dermatophagoides farinae
- Active ingredients
- Dermatophagoides pteronyssinus — 6 [arb'U]/1Dermatophagoides farinae — 6 [arb'U]/1
- Dosage form
- Tablet
- Route
- Sublingual
- Labeler
- ALK-Abello A SNDC labeler code 52709
- Product type
- Standardized allergenic
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125592
- 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 52709-1701_bc65092c-ce99-48c2-9585-40c4082ac192SPL ID bc65092c-ce99-48c2-9585-40c4082ac192
- 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 HCPCS code in Med-Code's directory. Sublingual products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N452709170103followed by a unit qualifier and the quantityPackage 52709-1701-03. 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 52709-1701
- What is NDC 52709-1701?
- 52709-1701 is the product NDC for Odactra, Dermatophagoides pteronyssinus 6 [arb'U]/1; Dermatophagoides farinae 6 [arb'U]/1 tablet, listed with the FDA by ALK-Abello A S. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Odactra (DERMATOPHAGOIDES PTERONYSSINUS and DERMATOPHAGOIDES FARINAE).
- What is the active ingredient?
- Dermatophagoides pteronyssinus, Dermatophagoides farinae.
- Who is the labeler?
- ALK-Abello A S, NDC labeler code 52709. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Odactra?
- 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.