Prescription drug · BLA
Pancreaze NDC 62541-401
pancrelipase lipase, pancrelipase amylase, and pancrelipase protease · Pancrelipase lipase 2600 [USP'U]/1 + 2 more ingredients · Capsule, Delayed release · Oral · VIVUS LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62541-401-10 | 62541040110 | 1 BOTTLE, GLASS in 1 CARTON (62541-401-10) / 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE, GLASSMarketed from Aug 1, 2016 |
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)
- Pancreaze
- Generic name (nonproprietary)
- pancrelipase lipase, pancrelipase amylase, and pancrelipase protease
- Active ingredients
- Pancrelipase lipase — 2600 [USP'U]/1Pancrelipase amylase — 15200 [USP'U]/1Pancrelipase protease — 8800 [USP'U]/1
- Dosage form
- Capsule, Delayed release
- Route
- Oral
- Labeler
- VIVUS LLCNDC labeler code 62541
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 022523
- Marketing start
- Listing expires
- Identifiers
- Product ID 62541-401_36e934b1-3fbb-8f0c-e063-6294a90a968cSPL ID 36e934b1-3fbb-8f0c-e063-6294a90a968cSPL set ID e8f5d2fe-728d-42af-99a6-83dddc6539c5RxCUI 1806919, 1806921, 1806924, 1806926, 1806929, 1806931, 1806964, 1806966, 2478453, 2478455, 2564410, 2564412UNII 8MYC33932O, 3560D81V50, YOJ58O116EUPC 0362541402102, 0362541403109, 0362541405103, 0362541401105, 0362541406100, 0362541404106
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
N462541040110followed by a unit qualifier and the quantityPackage 62541-0401-10. 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)
PANCREAZE is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients. PANCREAZE ® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 62541-401
- What is NDC 62541-401?
- 62541-401 is the product NDC for Pancreaze, Pancrelipase lipase 2600 [USP'U]/1 + 2 more ingredients capsule, delayed release, listed with the FDA by VIVUS LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pancreaze (PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE).
- What is the active ingredient?
- Pancrelipase lipase, Pancrelipase amylase, Pancrelipase protease.
- Who is the labeler?
- VIVUS LLC, NDC labeler code 62541. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Pancreaze?
- 5 other product NDCs are listed under this name. See all Pancreaze NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Pancreaze products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Pancreazepancrelipase lipase, pancrelipase amylase, and pancrelipase protease | Pancrelipase lipase 37000 [USP'U]/1 + 2 more ingredients | Capsule, Delayed releaseOral | VIVUS LLC | 62541-406 | 62541-0406-10 |
| Pancreazepancrelipase lipase, pancrelipase amylase, and pancrelipase protease | Pancrelipase lipase 4200 [USP'U]/1 + 2 more ingredients | Capsule, Delayed releaseOral | VIVUS LLC | 62541-402 | 62541-0402-10 |
| Pancreazepancrelipase lipase, pancrelipase amylase, and pancrelipase protease | Pancrelipase lipase 10500 [USP'U]/1 + 2 more ingredients | Capsule, Delayed releaseOral | VIVUS LLC | 62541-403 | 62541-0403-10 |
| Pancreazepancrelipase lipase, pancrelipase amylase, and pancrelipase protease | Pancrelipase lipase 16800 [USP'U]/1 + 2 more ingredients | Capsule, Delayed releaseOral | VIVUS LLC | 62541-404 | 62541-0404-10 |
| Pancreazepancrelipase lipase, pancrelipase amylase, and pancrelipase protease | Pancrelipase lipase 21000 [USP'U]/1 + 2 more ingredients | Capsule, Delayed releaseOral | VIVUS LLC | 62541-405 | 62541-0405-10 |
Other NDCs under BLA 022523
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 |
|---|---|---|---|---|
| Pancreazepancrelipase lipase, pancrelipase amylase, and pancrelipase protease | Pancrelipase lipase 4200 [USP'U]/1 + 2 more ingredients | Capsule, Delayed releaseOral | VIVUS LLC | 62541-402 |
| Pancreazepancrelipase lipase, pancrelipase amylase, and pancrelipase protease | Pancrelipase lipase 10500 [USP'U]/1 + 2 more ingredients | Capsule, Delayed releaseOral | VIVUS LLC | 62541-403 |
| Pancreazepancrelipase lipase, pancrelipase amylase, and pancrelipase protease | Pancrelipase lipase 16800 [USP'U]/1 + 2 more ingredients | Capsule, Delayed releaseOral | VIVUS LLC | 62541-404 |
| Pancreazepancrelipase lipase, pancrelipase amylase, and pancrelipase protease | Pancrelipase lipase 21000 [USP'U]/1 + 2 more ingredients | Capsule, Delayed releaseOral | VIVUS LLC | 62541-405 |
| Pancreazepancrelipase lipase, pancrelipase amylase, and pancrelipase protease | Pancrelipase lipase 37000 [USP'U]/1 + 2 more ingredients | Capsule, Delayed releaseOral | VIVUS LLC | 62541-406 |