What is NDC 49643-704?

49643-704 is the product NDC for House Dust Mite, Dermatophagoides pteronyssinus, Dermatophagoides pteronyssinus 10000 [AU]/mL injection, listed with the FDA by Allermed Laboratories, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

House Dust Mite, Dermatophagoides pteronyssinus.

What is the active ingredient?

Dermatophagoides pteronyssinus.

Allermed Laboratories, Inc., NDC labeler code 49643. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for House Dust Mite, Dermatophagoides pteronyssinus?

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.

NDC 49643-704

NDC codes

FDA NDC Directory

Product NDC (as listed)49643-704Labeler and product segments. Claims need a package NDC.

Product NDC at billing width49643-0704Add 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 NDC	11-digit (billing)	Package
49643-704-05	49643070405	5 mL in 1 VIAL, MULTI-DOSE (49643-704-05)Marketed from Dec 24, 1986
49643-704-10	49643070410	10 mL in 1 VIAL, MULTI-DOSE (49643-704-10)Marketed from Dec 24, 1986
49643-704-30	49643070430	30 mL in 1 VIAL, MULTI-DOSE (49643-704-30)Marketed from Dec 24, 1986
49643-704-50	49643070450	50 mL in 1 VIAL, MULTI-DOSE (49643-704-50)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 pteronyssinus
Generic name (nonproprietary): house dust mite, dermatophagoides pteronyssinus
Active ingredients: Dermatophagoides pteronyssinus — 10000 [AU]/mL
Dosage form: Injection
Route: Cutaneous, Intradermal, Subcutaneous
Labeler: Allermed Laboratories, Inc.NDC labeler code 49643
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 102213
Marketing start: Dec 24, 1986
Listing expires: Dec 31, 2026
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 49643-704_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.

How CPT relates to drug billing

NDC on a medical claim

N449643070405 followed by a unit qualifier and the quantity

Package 49643-0704-05. 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 Jun 3, 2025. 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.

Full label on DailyMed (opens in a new tab)

About NDC 49643-704

What is NDC 49643-704?: 49643-704 is the product NDC for House Dust Mite, Dermatophagoides pteronyssinus, Dermatophagoides pteronyssinus 10000 [AU]/mL injection, listed with the FDA by Allermed Laboratories, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: House Dust Mite, Dermatophagoides pteronyssinus.
What is the active ingredient?: Dermatophagoides pteronyssinus.
Who is the labeler?: Allermed Laboratories, Inc., NDC labeler code 49643. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for House Dust Mite, Dermatophagoides pteronyssinus?: 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.

House Dust Mite, Dermatophagoides pteronyssinus NDC 49643-704