NDC codes

FDA NDC Directory
Product NDC (as listed)73562-208Labeler and product segments. Claims need a package NDC.
Product NDC at billing width73562-0208Add 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
73562-208-1073562020810735620208101 BOTTLE in 1 CARTON (73562-208-10) / 100 TABLET in 1 BOTTLEMarketed from Mar 1, 2021

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)
Viokace
Generic name (nonproprietary)
pancrelipase
Active ingredients
Pancrelipase lipase — 20880 [USP'U]/1Pancrelipase protease — 78300 [USP'U]/1Pancrelipase amylase — 78300 [USP'U]/1
Dosage form
Tablet
Route
Oral
Labeler
Aimmune Therapeutics, Inc.NDC labeler code 73562
Product type
Prescription drug
Marketing category
BLA — Biologics License ApplicationApplication BLA 022542
Marketing start
Listing expires
Identifiers
Product ID 73562-208_95ece3e2-a51f-4f4c-81ec-71aa2930a158SPL ID 95ece3e2-a51f-4f4c-81ec-71aa2930a158SPL set ID 58bdb8de-582d-44e6-9b72-8d5a42fdf501RxCUI 1247379, 1247381, 1247386, 1247388UNII 8MYC33932O, 3560D81V50, YOJ58O116E

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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N473562020810 followed by a unit qualifier and the quantity

Package 73562-0208-10. 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

Current FDA label (SPL), effective .

Indications (excerpt from the label)

1. INDICATIONS AND USAGE VIOKACE, in combination with a proton pump inhibitor, is indicated for the treatment of exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy in adults. VIOKACE, in combination with a proton pump inhibitor, is indicated for the treatment of exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy in adults. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 73562-208

What is NDC 73562-208?
73562-208 is the product NDC for Viokace (pancrelipase), Pancrelipase lipase 20880 [USP'U]/1 + 2 more ingredients tablet, listed with the FDA by Aimmune Therapeutics, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Viokace (Pancrelipase).
What is the active ingredient?
Pancrelipase lipase, Pancrelipase protease, Pancrelipase amylase.
Who is the labeler?
Aimmune Therapeutics, Inc., NDC labeler code 73562. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Viokace?
1 other product NDC are listed under this name. See all Viokace 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 Viokace NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
ViokacepancrelipasePancrelipase lipase 10440 [USP'U]/1 + 2 more ingredientsTabletOralAimmune Therapeutics, Inc.73562-10473562-0104-10

Other NDCs under BLA 022542

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

FDA NDC Directory listings under BLA 022542
ProductStrengthForm · routeLabelerProduct NDC
ViokacepancrelipasePancrelipase lipase 10440 [USP'U]/1 + 2 more ingredientsTabletOralAimmune Therapeutics, Inc.73562-104

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