Active ingredient
Linaclotide
3 finished FDA listings contain Linaclotide as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- LINACLOTIDE
- Dosage forms
- Capsule, Gelatin Coated
- Routes
- Oral
- Manufacturers / labelers
- 1
- Strengths listed
- 145 ug/1 · 290 ug/1 · 72 ug/1
- Brand names in FDA listings
- Linzess
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1307404
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 202811 | ABBVIE | 2012-08-30 | 3 |
Official labeling on DailyMed
- LINZESS (LINACLOTIDE) CAPSULE, GELATIN COATED [ALLERGAN, INC.] · version 39 · 2026-06-01
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.