NDC 0032-2637 – Creon
Pancrelipase Lipase 36000 [USP'U]/1; Pancrelipase Amylase 180000 [USP'U]/1; Pancrelipase Protease 114000 [USP'U]/1 · Capsule, Delayed Release Pellets · Oral
Product NDC0032-2637
Product details
- Brand name
- Creon
- Generic name
- Pancrelipase
- Labeler
- AbbVie Inc.
- Dosage form
- Capsule, Delayed Release Pellets
- Route
- Oral
- Marketing category
- BLA · BLA020725
- Marketed since
- October 12, 2023
- Listing expires
- December 31, 2027
Active ingredients
- Pancrelipase Lipase 36000 [USP'U]/1
- Pancrelipase Amylase 180000 [USP'U]/1
- Pancrelipase Protease 114000 [USP'U]/1
Package NDC codes (3)
| Package NDC | Description | Since |
|---|---|---|
| 0032-2637-01 | 100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (0032-2637-01) | Oct 12, 2023 |
| 0032-2637-30 sample | 1 BOTTLE in 1 CARTON (0032-2637-30) / 24 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE | Oct 12, 2023 |
| 0032-2637-70 | 240 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (0032-2637-70) | Oct 12, 2023 |
Recalls mentioning this NDC
- D-0402-2021 Jun 2, 2021 · Class II
CGMP Deviations: Intermittent exposure to temperature excursion during storage. - D-1611-2014 Oct 8, 2014 · Class II
Presence of Foreign Tablets/Capsules; Presence of co-mingled LipaCreon 13000.
Other Creon products
- 0032-0045 Pancrelipase Amylase 15000 [USP'U]/1; Pancrelipase Lipase 3000… · Capsule, Delayed Release · AbbVie Inc.
- 0032-0046 Pancrelipase Amylase 30000 [USP'U]/1; Pancrelipase Lipase 6000… · Capsule, Delayed Release Pellets · AbbVie Inc.
- 0032-0047 Pancrelipase Amylase 60000 [USP'U]/1; Pancrelipase Lipase 12000… · Capsule, Delayed Release Pellets · AbbVie Inc.
- 0032-1203 Pancrelipase Amylase 15000 [USP'U]/1; Pancrelipase Lipase 3000… · Capsule, Delayed Release · AbbVie Inc.
- 0032-1206 Pancrelipase Amylase 30000 [USP'U]/1; Pancrelipase Lipase 6000… · Capsule, Delayed Release Pellets · AbbVie Inc.
- 0032-1212 Pancrelipase Amylase 60000 [USP'U]/1; Pancrelipase Lipase 12000… · Capsule, Delayed Release Pellets · AbbVie Inc.
- 0032-1224 Pancrelipase Lipase 24000 [USP'U]/1; Pancrelipase Protease 76000… · Capsule, Delayed Release Pellets · AbbVie Inc.
- 0032-2636 Pancrelipase Lipase 24000 [USP'U]/1; Pancrelipase Protease 76000… · Capsule, Delayed Release Pellets · AbbVie Inc.
- 0032-3016 Pancrelipase Lipase 36000 [USP'U]/1; Pancrelipase Amylase 180000… · Capsule, Delayed Release Pellets · AbbVie Inc.