Adynovate NDC 0944-4622

NDC codes

FDA NDC Directory

Product NDC (as listed)0944-4622Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00944-4622Add 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
0944-4622-01	00944462201	1 KIT in 1 CARTON (0944-4622-01) / 1 CONTAINER in 1 KIT (0944-4622-02) / 1 KIT in 1 CONTAINER (0944-4622-03) * 5 mL in 1 VIAL, GLASS (0944-4137-01) * 2 mL in 1 VIAL, GLASS (64764-514-02)Marketed from Jul 28, 2016

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): Adynovate
Generic name (nonproprietary): antihemophilic factor (recombinant) pegylated
Dosage form: Kit
Labeler: Takeda Pharmaceuticals Amercia, Inc.
Product type: Plasma derivative
Marketing category: BLA — Biologics License ApplicationApplication BLA 125566
Marketing start: Jul 28, 2016
Listing expires: Dec 31, 2027
Identifiers: Product ID 0944-4622_24de100e-5b4b-4bc7-ba3a-6dc768df9eb0SPL ID 24de100e-5b4b-4bc7-ba3a-6dc768df9eb0

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.

NDC on a medical claim

N400944462201 followed by a unit qualifier and the quantity

Package 00944-4622-01. 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 125566

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

FDA NDC Directory listings under BLA 125566
Product	Strength	Form · route	Labeler	Product NDC
Adynovateantihemophilic factor (recombinant) pegylated	—	Kit	Takeda Pharmaceuticals Amercia, Inc.	0944-4628
Adynovateantihemophilic factor (recombinant) pegylated	—	Kit	Takeda Pharmaceuticals Amercia, Inc.	0944-4623
Adynovateantihemophilic factor (recombinant) pegylated	—	Kit	Takeda Pharmaceuticals Amercia, Inc.	0944-4624
Adynovateantihemophilic factor (recombinant) pegylated	—	Kit	Takeda Pharmaceuticals Amercia, Inc.	0944-4625
Adynovateantihemophilic factor (recombinant) pegylated	—	Kit	Takeda Pharmaceuticals Amercia, Inc.	0944-4626
Adynovateantihemophilic factor (recombinant) pegylated	—	Kit	Takeda Pharmaceuticals Amercia, Inc.	0944-4627