Prescription drug · NDA
Linzess (Linaclotide) NDC 50090-8108
Linaclotide 145 ug/1 · Capsule, Gelatin coated · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-8108-0 | 5009081080050090810800 | 1 BOTTLE in 1 CARTON (50090-8108-0) / 30 CAPSULE, GELATIN COATED in 1 BOTTLEMarketed from Oct 8, 2026 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Linzess
- Generic name (nonproprietary)
- linaclotide
- Active ingredients
- Linaclotide — 145 ug/1
- Dosage form
- Capsule, Gelatin coated
- Route
- Oral
- Labeler
- A-S Medication SolutionsNDC labeler code 50090
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 202811
- Marketing start
- Listing expires
- Other FDA classes
- Guanylate Cyclase Activators (Mechanism)
- Identifiers
- Product ID 50090-8108_85c64bef-a2a9-4d9b-95c8-603c5ff4b7e1SPL ID 85c64bef-a2a9-4d9b-95c8-603c5ff4b7e1
- Pharmacologic class
- Guanylate Cyclase-C Agonist
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
N450090810800followed by a unit qualifier and the quantityPackage 50090-8108-00. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 50090-8108
- What is NDC 50090-8108?
- 50090-8108 is the product NDC for Linzess (linaclotide), Linaclotide 145 ug/1 capsule, gelatin coated, listed with the FDA by A-S Medication Solutions. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Linzess (Linaclotide).
- What is the active ingredient?
- Linaclotide.
- Who is the labeler?
- A-S Medication Solutions, NDC labeler code 50090. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Linzess?
- 3 other product NDCs are listed under this name. See all Linzess NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Linzess products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Linzesslinaclotide | Linaclotide 72 ug/1 | Capsule, Gelatin coatedOral | Allergan, Inc. | 0456-1203 | 00456-1203-0400456-1203-0700456-1203-30 |
| Linzesslinaclotide | Linaclotide 145 ug/1 | Capsule, Gelatin coatedOral | Allergan, Inc. | 0456-1201 | 00456-1201-0400456-1201-0700456-1201-30 |
| Linzesslinaclotide | Linaclotide 290 ug/1 | Capsule, Gelatin coatedOral | Allergan, Inc. | 0456-1202 | 00456-1202-0400456-1202-0700456-1202-30 |
Other NDCs under NDA 202811
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 |
|---|---|---|---|---|
| Linzesslinaclotide | Linaclotide 145 ug/1 | Capsule, Gelatin coatedOral | Allergan, Inc. | 0456-1201 |
| Linzesslinaclotide | Linaclotide 290 ug/1 | Capsule, Gelatin coatedOral | Allergan, Inc. | 0456-1202 |
| Linzesslinaclotide | Linaclotide 72 ug/1 | Capsule, Gelatin coatedOral | Allergan, Inc. | 0456-1203 |