NDC codes

FDA NDC Directory
Product NDC (as listed)52709-1701Labeler and product segments. Claims need a package NDC.
Product NDC at billing width52709-1701Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
52709-1701-3527091701033 BLISTER PACK in 1 CARTON (52709-1701-3) / 10 TABLET in 1 BLISTER PACK (52709-1701-1)Marketed from Jan 1, 2018
52709-1701-5527091701051 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

N452709170103 followed by a unit qualifier and the quantity

Package 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.

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