What is NDC 0268-7002?

0268-7002 is the product NDC for Standardized Mite, Mixed, Dermatophagoides farinae 10000 [AU]/mL; Dermatophagoides pteronyssinus 10000 [AU]/mL injection, solution, listed with the FDA by ALK-Abello, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Dermatophagoides farinae, Dermatophagoides pteronyssinus.

ALK-Abello, Inc., NDC labeler code 0268. 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, Mixed?

1 other product NDC are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Standardized Mite, Mixed NDC 0268-7002

NDC codes

FDA NDC Directory

Product NDC (as listed)0268-7002Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00268-7002Add 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	Copy
0268-7002-10	00268700210	10 mL in 1 VIAL (0268-7002-10)Marketed from Jul 8, 1991
0268-7002-50	00268700250	50 mL in 1 VIAL (0268-7002-50)Marketed from Jul 8, 1991

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Standardized Mite, Mixed
Generic name (nonproprietary): standardized mite, mixed
Active ingredients: Dermatophagoides farinae — 10000 [AU]/mLDermatophagoides pteronyssinus — 10000 [AU]/mL
Dosage form: Injection, Solution
Route: Subcutaneous
Labeler: ALK-Abello, Inc.NDC labeler code 0268
Product type: Standardized allergenic
Marketing category: BLA — Biologics License ApplicationApplication BLA 103060
Marketing start: Jul 8, 1991
Listing expires: Dec 31, 2026
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 0268-7002_99cfd9aa-141f-48cf-8b7f-41f0d6891749SPL ID 99cfd9aa-141f-48cf-8b7f-41f0d6891749
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

N400268700210 followed by a unit qualifier and the quantity

Package 00268-7002-10. 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 0268-7002

What is NDC 0268-7002?: 0268-7002 is the product NDC for Standardized Mite, Mixed, Dermatophagoides farinae 10000 [AU]/mL; Dermatophagoides pteronyssinus 10000 [AU]/mL injection, solution, listed with the FDA by ALK-Abello, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Standardized Mite, Mixed.
What is the active ingredient?: Dermatophagoides farinae, Dermatophagoides pteronyssinus.
Who is the labeler?: ALK-Abello, Inc., NDC labeler code 0268. 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, Mixed?: 1 other product NDC are listed under this name. See all Standardized Mite, Mixed NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Standardized Mite, Mixed NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Standardized Mite, Mixeddermatophagoides farinae and dermatophagoides pteronyssinus	Dermatophagoides farinae 5000 [AU]/mL; Dermatophagoides pteronyssinus 5000 [AU]/mL	Injection, SolutionPercutaneous	ALK-Abello, Inc.	0268-8116	00268-8116-06

Other NDCs under BLA 103060

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under BLA 103060
Product	Strength	Form · route	Labeler	Product NDC
Standardized Mite D. farinae	Dermatophagoides farinae 10000 [AU]/mL	Injection, SolutionSubcutaneous	ALK-Abello, Inc.	0268-0275
Standardized Mite D. farinae	Dermatophagoides farinae 10000 [AU]/mL	SolutionPercutaneous	ALK-Abello, Inc.	0268-7000
Standardized Mite, Mixeddermatophagoides farinae and dermatophagoides pteronyssinus	Dermatophagoides farinae 5000 [AU]/mL; Dermatophagoides pteronyssinus 5000 [AU]/mL	Injection, SolutionPercutaneous	ALK-Abello, Inc.	0268-8116