NDC 0456-1202 – Linzess
Linaclotide 290 ug/1 · Capsule, Gelatin Coated · Oral
Product NDC0456-1202
Product details
- Brand name
- Linzess
- Generic name
- linaclotide
- Labeler
- Allergan, Inc.
- Dosage form
- Capsule, Gelatin Coated
- Route
- Oral
- Marketing category
- NDA · NDA202811
- Marketed since
- September 8, 2012
- Listing expires
- December 31, 2027
- Pharmacologic class
- Guanylate Cyclase-C Agonist
Active ingredients
- Linaclotide 290 ug/1
Package NDC codes (3)
| Package NDC | Description | Since |
|---|---|---|
| 0456-1202-04 sample | 1 BOTTLE in 1 CARTON (0456-1202-04) / 4 CAPSULE, GELATIN COATED in 1 BOTTLE | Sep 8, 2012 |
| 0456-1202-07 sample | 1 BOTTLE in 1 CARTON (0456-1202-07) / 7 CAPSULE, GELATIN COATED in 1 BOTTLE | May 17, 2019 |
| 0456-1202-30 | 1 BOTTLE in 1 CARTON (0456-1202-30) / 30 CAPSULE, GELATIN COATED in 1 BOTTLE | Sep 8, 2012 |
Recalls mentioning this NDC
- D-0417-2021 Jun 2, 2021 · Class II
CGMP Deviations: Intermittent exposure to temperature excursion during storage.