NDC codes

FDA NDC Directory
Product NDC (as listed)76125-256Labeler and product segments. Claims need a package NDC.
Product NDC at billing width76125-0256Add 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
76125-256-20761250256201 KIT in 1 CARTON (76125-256-20) * 5 mL in 1 VIAL, GLASS (76125-252-21) * 5 mL in 1 VIAL, GLASS (13533-000-04)Marketed from May 20, 1999

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)
Koate
Generic name (nonproprietary)
antihemophilic factor (human)
Dosage form
Kit
Route
Intravenous
Product type
Plasma derivative
Marketing category
BLA — Biologics License ApplicationApplication BLA 101130
Marketing start
Listing expires
Identifiers
Product ID 76125-256_703c908c-e602-4a36-9b58-1ba7206d18eaSPL ID 703c908c-e602-4a36-9b58-1ba7206d18ea

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

N476125025620 followed by a unit qualifier and the quantity

Package 76125-0256-20. 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.

Other NDCs under BLA 101130

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

FDA NDC Directory listings under BLA 101130
ProductStrengthForm · routeLabelerProduct NDC
Koateantihemophilic factor (human)KitIntravenousKEDRION BIOPHARMA, INC.76125-253
Koateantihemophilic factor (human)KitKEDRION BIOPHARMA, INC.76125-250
Koateantihemophilic factor (human)KitIntravenousKEDRION BIOPHARMA, INC.76125-258
Koateantihemophilic factor (human)KitIntravenousKEDRION BIOPHARMA, INC.76125-257
Koateantihemophilic factor (human)KitIntravenousKEDRION BIOPHARMA, INC.76125-663
Koateantihemophilic factor (human)KitIntravenousKEDRION BIOPHARMA, INC.76125-259
Koateantihemophilic factor (human)KitIntravenousKEDRION BIOPHARMA, INC.76125-661
Koateantihemophilic factor (human)KitIntravenousKEDRION BIOPHARMA, INC.76125-662
Koateantihemophilic factor (human)KitKEDRION BIOPHARMA, INC.76125-672
Koateantihemophilic factor (human)KitIntravenousKEDRION BIOPHARMA, INC.76125-665
Koateantihemophilic factor (human)KitKEDRION BIOPHARMA, INC.76125-667
Koateantihemophilic factor (human)KitIntravenousKEDRION BIOPHARMA, INC.76125-668
Koateantihemophilic factor (human)KitIntravenousKEDRION BIOPHARMA, INC.76125-676
Koateantihemophilic factor (human)KitIntravenousKEDRION BIOPHARMA, INC.76125-674
Koateantihemophilic factor (human)KitIntravenousKEDRION BIOPHARMA, INC.76125-675
Koateantihemophilic factor (human)KitIntravenousKEDRION BIOPHARMA, INC.76125-678
Koateantihemophilic factor (human)KitIntravenousKEDRION BIOPHARMA, INC.76125-679

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