Prescription drug · NDA
Linzess (Linaclotide) NDC 0456-1201
Linaclotide 145 ug/1 · Capsule, Gelatin coated · Oral · Allergan, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0456-1201-04 | 00456120104 | 1 BOTTLE in 1 CARTON (0456-1201-04) / 4 CAPSULE, GELATIN COATED in 1 BOTTLEMarketed from Sep 8, 2012 · Sample package | |
| 0456-1201-07 | 00456120107 | 1 BOTTLE in 1 CARTON (0456-1201-07) / 7 CAPSULE, GELATIN COATED in 1 BOTTLEMarketed from May 17, 2019 · Sample package | |
| 0456-1201-30 | 00456120130 | 1 BOTTLE in 1 CARTON (0456-1201-30) / 30 CAPSULE, GELATIN COATED in 1 BOTTLEMarketed from Sep 8, 2012 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Allergan, Inc.NDC labeler code 0456
- 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 0456-1201_621456b5-c1a3-48b8-99ac-ccbf8beebf43SPL ID 621456b5-c1a3-48b8-99ac-ccbf8beebf43SPL set ID 09beda19-56d6-4a56-afdc-9a77b70b2ef3RxCUI 1307409, 1307415, 1307419, 1307421, 1869697, 1869699UNII N0TXR0XR5XUPC 0304561203307, 0304561202300, 0304561201303
- 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
N400456120104followed by a unit qualifier and the quantityPackage 00456-1201-04. 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
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
LINZESS is indicated for the treatment of: • irritable bowel syndrome with constipation (IBS-C) in adults and pediatric patients 7 years of age and older • chronic idiopathic constipation (CIC) in adults • functional constipation (FC) in pediatric patients 2 years of age and older LINZESS is a guanylate cyclase-C agonist indicated for treatment of: Irritable bowel syndrome with constipation (IBS-C) in adults and pediatric patients 7 years of age and older. ( 1 ) Chronic idiopathic constipation (CIC) in adults. ( 1 ) Functional constipation (FC) in pediatric patients 2 years of age and older. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 0456-1201
- What is NDC 0456-1201?
- 0456-1201 is the product NDC for Linzess (linaclotide), Linaclotide 145 ug/1 capsule, gelatin coated, listed with the FDA by Allergan, Inc.. It has 3 package NDCs, 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?
- Allergan, Inc., NDC labeler code 0456. 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?
- 2 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 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 290 ug/1 | Capsule, Gelatin coatedOral | Allergan, Inc. | 0456-1202 |
| Linzesslinaclotide | Linaclotide 72 ug/1 | Capsule, Gelatin coatedOral | Allergan, Inc. | 0456-1203 |