Prescription drug · NDA
Amitiza (Lubiprostone) NDC 23635-508
Lubiprostone 8 ug/1 · Capsule, Gelatin coated · Oral · SpecGx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 23635-508-60 | 2363505086023635050860 | 60 CAPSULE, GELATIN COATED in 1 BOTTLE (23635-508-60)Marketed from Apr 1, 2024 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Amitiza
- Generic name (nonproprietary)
- lubiprostone
- Active ingredients
- Lubiprostone — 8 ug/1
- Dosage form
- Capsule, Gelatin coated
- Route
- Oral
- Labeler
- SpecGx LLCNDC labeler code 23635
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021908
- Marketing start
- Listing expires
- Other FDA classes
- Chloride Channel Activators (Mechanism)
- Identifiers
- Product ID 23635-508_2b3f0621-b444-472d-ab37-b82d0baa93e2SPL ID 2b3f0621-b444-472d-ab37-b82d0baa93e2SPL set ID 164a2b47-0a52-4bb4-9e71-5342c2e951f4RxCUI 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.
- NDC on a medical claim
N423635050860followed by a unit qualifier and the quantityPackage 23635-0508-60. 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 .
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 23635-508
- What is NDC 23635-508?
- 23635-508 is the product NDC for Amitiza (lubiprostone), Lubiprostone 8 ug/1 capsule, gelatin coated, listed with the FDA by SpecGx LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Amitiza (Lubiprostone).
- What is the active ingredient?
- Lubiprostone.
- Who is the labeler?
- SpecGx LLC, NDC labeler code 23635. 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 24 ug/1 | Capsule, Gelatin coatedOral | SpecGx LLC | 23635-524 | 23635-0524-60 |
| Amitizalubiprostone | Lubiprostone 8 ug/1 | Capsule, Gelatin coatedOral | Takeda Pharmaceuticals America, Inc. | 64764-080 | — |
| 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 24 ug/1 | Capsule, Gelatin coatedOral | SpecGx LLC | 23635-524 |
| Amitizalubiprostone | Lubiprostone 8 ug/1 | Capsule, Gelatin coatedOral | Takeda Pharmaceuticals America, Inc. | 64764-080 |
| 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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