Prescription drug · NDA
Amitiza (Lubiprostone) NDC 64764-080
Lubiprostone 8 ug/1 · Capsule, Gelatin coated · Oral · Takeda Pharmaceuticals America, Inc.
NDC codes
FDA NDC DirectoryProduct information
- Brand name (proprietary)
- Amitiza
- Generic name (nonproprietary)
- lubiprostone
- Active ingredients
- Lubiprostone — 8 ug/1
- Dosage form
- Capsule, Gelatin coated
- Route
- Oral
- Labeler
- Takeda Pharmaceuticals America, Inc.NDC labeler code 64764
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021908
- Marketing start
- Marketing end
- Other FDA classes
- Chloride Channel Activators (Mechanism)
- Identifiers
- Product ID 64764-080_c2ca8178-4da1-42d1-a8b9-ff66dca82649SPL ID c2ca8178-4da1-42d1-a8b9-ff66dca82649SPL set ID d474ac6a-444d-4aa6-9986-24be6fcf811dRxCUI 616578, 617768, 794639, 794641UNII 7662KG2R6K
- Pharmacologic class
- Chloride Channel Activator
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.
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Amitiza is a chloride channel activator indicated for the treatment of: chronic idiopathic constipation (CIC) in adults. ( 1.1 ) opioid-induced constipation (OIC) in adult patients with chronic, non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. ( 1.2 ) Limitations of Use: Effectiveness of Amitiza in the treatment of OIC in patients taking diphenylheptane opioids (e.g., methadone) has not been established. ( 1.2 , 7.1 ) irritable bowel syndrome with constipation (IBS-C) in women ≥ 18 years old. ( 1.3 ) 1.1 Chronic Idiopathic Constipation in Adults Amitiza ® is indicated for the tr…
Excerpt only. Read the full label for complete information.
About NDC 64764-080
- What is NDC 64764-080?
- 64764-080 is the product NDC for Amitiza (lubiprostone), Lubiprostone 8 ug/1 capsule, gelatin coated, listed with the FDA by Takeda Pharmaceuticals America, Inc..
- What drug is associated with this NDC?
- Amitiza (Lubiprostone).
- What is the active ingredient?
- Lubiprostone.
- Who is the labeler?
- Takeda Pharmaceuticals America, Inc., NDC labeler code 64764. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Amitiza?
- 3 other product NDCs are listed under this name. See all Amitiza NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Amitiza products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Amitizalubiprostone | Lubiprostone 8 ug/1 | Capsule, Gelatin coatedOral | SpecGx LLC | 23635-508 | 23635-0508-60 |
| Amitizalubiprostone | Lubiprostone 24 ug/1 | Capsule, Gelatin coatedOral | SpecGx LLC | 23635-524 | 23635-0524-60 |
| Amitizalubiprostone | Lubiprostone 24 ug/1 | Capsule, Gelatin coatedOral | Takeda Pharmaceuticals America, Inc. | 64764-240 | 64764-0240-60 |
Other NDCs under NDA 021908
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 |
|---|---|---|---|---|
| Amitizalubiprostone | Lubiprostone 8 ug/1 | Capsule, Gelatin coatedOral | SpecGx LLC | 23635-508 |
| Amitizalubiprostone | Lubiprostone 24 ug/1 | Capsule, Gelatin coatedOral | SpecGx LLC | 23635-524 |
| Amitizalubiprostone | Lubiprostone 24 ug/1 | Capsule, Gelatin coatedOral | Takeda Pharmaceuticals America, Inc. | 64764-240 |
| Lubiprostone | Lubiprostone 8 ug/1 | Capsule, Gelatin coatedOral | Par Health USA, LLC | 0254-3028 |
| Lubiprostone | Lubiprostone 24 ug/1 | Capsule, Gelatin coatedOral | Par Health USA, LLC | 0254-3029 |
| Lubiprostone | Lubiprostone 8 ug/1 | Capsule, Gelatin coatedOral | SpecGx LLC | 0406-6408 |
| Lubiprostone | Lubiprostone 24 ug/1 | Capsule, Gelatin coatedOral | SpecGx LLC | 0406-6424 |
| Lubiprostone | Lubiprostone 8 ug/1 | Capsule, Gelatin coatedOral | Dr. Reddy's Laboratories Inc. | 43598-163 |
| Lubiprostone | Lubiprostone 24 ug/1 | Capsule, Gelatin coatedOral | Dr. Reddy's Laboratories Inc. | 43598-168 |
| Lubiprostone | Lubiprostone 8 ug/1 | Capsule, Gelatin coatedOral | Golden State Medical Supply, Inc. | 51407-744 |
| Lubiprostone | Lubiprostone 24 ug/1 | Capsule, Gelatin coatedOral | Golden State Medical Supply, Inc. | 51407-745 |
| Lubiprostone | Lubiprostone 8 ug/1 | Capsule, Gelatin coatedOral | Sun Pharmaceutical Industries, Inc. | 63304-351 |
| Lubiprostone | Lubiprostone 24 ug/1 | Capsule, Gelatin coatedOral | Sun Pharmaceutical Industries, Inc. | 63304-352 |
| Lubiprostone | Lubiprostone 8 ug/1 | Capsule, Gelatin coatedOral | Natco Pharma USA LLC | 69339-162 |
| Lubiprostone | Lubiprostone 24 ug/1 | Capsule, Gelatin coatedOral | Natco Pharma USA LLC | 69339-163 |
| Lubiprostone | Lubiprostone 8 ug/1 | Capsule, Gelatin coatedOral | Proficient Rx LP | 71205-831 |
| Lubiprostone | Lubiprostone 24 ug/1 | Capsule, Gelatin coatedOral | Proficient Rx LP | 71205-832 |
| Lubiprostone | Lubiprostone 24 ug/1 | Capsule, Gelatin coatedOral | Proficient Rx LP | 71205-834 |
| Lubiprostone | Lubiprostone 24 ug/1 | Capsule, Gelatin coatedOral | Direct Rx | 72189-607 |
| Lubiprostone | Lubiprostone 8 ug/1 | Capsule, Gelatin coatedOral | Asclemed USA, Inc. | 76420-906 |
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