Prescription drug · BLA
Viokace (Pancrelipase) NDC 73562-208
Pancrelipase lipase 20880 [USP'U]/1 + 2 more ingredients · Tablet · Oral · Aimmune Therapeutics, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 73562-208-10 | 7356202081073562020810 | 1 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
N473562020810followed by a unit qualifier and the quantityPackage 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.
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.
Related NDCs: other Viokace products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Viokacepancrelipase | Pancrelipase lipase 10440 [USP'U]/1 + 2 more ingredients | TabletOral | Aimmune Therapeutics, Inc. | 73562-104 | 73562-0104-10 |
Other NDCs under BLA 022542
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Viokacepancrelipase | Pancrelipase lipase 10440 [USP'U]/1 + 2 more ingredients | TabletOral | Aimmune Therapeutics, Inc. | 73562-104 |