NDC codes

FDA NDC Directory
Product NDC (as listed)22840-0216Labeler and product segments. Claims need a package NDC.
Product NDC at billing width22840-0216Add 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
22840-0216-22284002160210 mL in 1 VIAL, MULTI-DOSE (22840-0216-2)Marketed from Sep 15, 1968
22840-0216-42284002160450 mL in 1 VIAL, MULTI-DOSE (22840-0216-4)Marketed from Sep 15, 1968
22840-0216-5228400216055 mL in 1 BOTTLE, DROPPER (22840-0216-5)Marketed from Sep 15, 1968

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)
K-O-T Standardized Grass Pollen Mix
Generic name (nonproprietary)
poa pratensis, dactylis glomerata and phleum pratense
Active ingredients
Poa pratensis pollen3333.333 [BAU]/mLDactylis glomerata pollen3333.333 [BAU]/mLPhleum pratense pollen3333.333 [BAU]/mL
Dosage form
Solution
Route
Intradermal, Percutaneous, Subcutaneous
Product type
Standardized allergenic
Marketing category
BLA — Biologics License ApplicationApplication BLA 101837
Marketing start
Listing expires
Other FDA classes
Allergens (Chemical structure)Allergens (Chemical structure)Allergens (Chemical structure)Cell-mediated Immunity (Physiologic effect)Cell-mediated Immunity (Physiologic effect)Cell-mediated Immunity (Physiologic effect)Increased Histamine Release (Physiologic effect)Increased Histamine Release (Physiologic effect)Increased Histamine Release (Physiologic effect)Increased IgG Production (Physiologic effect)Increased IgG Production (Physiologic effect)Increased IgG Production (Physiologic effect)Pollen (Chemical structure)Pollen (Chemical structure)Pollen (Chemical structure)
Identifiers
Product ID 22840-0216_37385fc6-1cdd-8aa6-e063-6294a90a6017SPL ID 37385fc6-1cdd-8aa6-e063-6294a90a6017
Pharmacologic class
Standardized Pollen 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

N422840021602 followed by a unit qualifier and the quantity

Package 22840-0216-02. 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.

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