Creon
- Product NDC
- 0032-0047
- 11-digit product format
- 000320047
- Labeler code
- 0032
- Product ID
- 0032-0047_94463229-9296-4640-854f-41d76386d312
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pancrelipase
- Dosage form
- CAPSULE, DELAYED RELEASE PELLETS
- Route
- ORAL
- Labeler
- AbbVie Inc.
- Application
- BLA020725
- Marketing category
- BLA
- Marketing start
- 2023-10-12
- Substance
- PANCRELIPASE AMYLASE; PANCRELIPASE LIPASE; PANCRELIPASE PROTEASE
- Active strength
- 60000; 12000; 38000 [USP'U]/1; [USP'U]/1; [USP'U]/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| YOJ58O116E | PANCRELIPASE AMYLASE | 9000-90-2 | PANCRELIPASE AMYLASE |
| 8MYC33932O | PANCRELIPASE LIPASE | 9001-62-1 | PANCRELIPASE LIPASE |
| 3560D81V50 | PANCRELIPASE PROTEASE | 9001-94-9 | PANCRELIPASE PROTEASE |
| FQ3DRG0N5K | PANCRELIPASE | 53608-75-6 | Pancrelipase |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0032-0047-30 | 00032004730 | 100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (0032-0047-30) | 2023-10-12 | Yes | No | Historical |
| 0032-0047-70 | 00032004770 | 100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (0032-0047-70) | 2023-10-12 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Creon | AbbVie Inc. | 2024-02-28 | HUMAN PRESCRIPTION DRUG LABEL | 108 |