NDC codes

FDA NDC Directory
Product NDC (as listed)68516-4616Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68516-4616Add 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
68516-4616-1685164616011 KIT in 1 CARTON (68516-4616-1) * 5 mL in 1 VIAL (68516-4605-1) * 5 mL in 1 VIAL, GLASS (76297-002-02)Marketed from Aug 15, 1978

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)
Alphanate
Generic name (nonproprietary)
antihemophilic factor/von willebrand factor complex (human)
Dosage form
Kit
Route
Intravenous
Product type
Plasma derivative
Marketing category
BLA — Biologics License ApplicationApplication BLA 102475
Marketing start
Listing expires
Identifiers
Product ID 68516-4616_62efdce0-9d8e-47ee-954c-9a4cbdfb525dSPL ID 62efdce0-9d8e-47ee-954c-9a4cbdfb525d

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

N468516461601 followed by a unit qualifier and the quantity

Package 68516-4616-01. 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 102475

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

FDA NDC Directory listings under BLA 102475
ProductStrengthForm · routeLabelerProduct NDC
Alphanateantihemophilic factor/von willebrand factor complex (human)—KitIntravenousGRIFOLS USA, LLC68516-4617
Alphanateantihemophilic factor/von willebrand factor complex (human)—KitIntravenousGRIFOLS USA, LLC68516-4618
Alphanateantihemophilic factor/von willebrand factor complex (human)—KitIntravenousGRIFOLS USA, LLC68516-4619
Alphanateantihemophilic factor/von willebrand factor complex (human)—KitIntravenousGRIFOLS USA, LLC68516-4620

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Alphanate NDC 68516-4616 | Med-Code