Prescription drug · NDA AUTHORIZED GENERIC
Lubiprostone NDC 0254-3029
Lubiprostone 24 ug/1 · Capsule, Gelatin coated · Oral · Par Health USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0254-3029-02 | 00254302902 | 60 CAPSULE, GELATIN COATED in 1 BOTTLE (0254-3029-02)Marketed from Jan 1, 2021 |
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)
- Lubiprostone
- Generic name (nonproprietary)
- lubiprostone
- Active ingredients
- Lubiprostone — 24 ug/1
- Dosage form
- Capsule, Gelatin coated
- Route
- Oral
- Labeler
- Par Health USA, LLC
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 021908
- Marketing start
- Listing expires
- Other FDA classes
- Chloride Channel Activators (Mechanism)
- Identifiers
- Product ID 0254-3029_0f9f3d85-4e13-438a-b590-17a126a3ef99SPL ID 0f9f3d85-4e13-438a-b590-17a126a3ef99SPL set ID 9d958b58-6c4f-4bb1-8660-cf5eac256440RxCUI 616578, 794639UNII 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
N400254302902followed by a unit qualifier and the quantityPackage 00254-3029-02. 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)
Lubiprostone 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 lubiprostone 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 Lubiprostone is indicat…
Excerpt only. Read the full label for complete information.
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 |
|---|---|---|---|---|
| Lubiprostone | Lubiprostone 8 ug/1 | Capsule, Gelatin coatedOral | Par Health USA, LLC | 0254-3028 |
| Lubiprostone | Lubiprostone 8 ug/1 | Capsule, Gelatin coatedOral | Sun Pharmaceutical Industries, Inc. | 63304-351 |
| Lubiprostone | Lubiprostone 8 ug/1 | Capsule, Gelatin coatedOral | Golden State Medical Supply, Inc. | 51407-744 |
| Lubiprostone | Lubiprostone 24 ug/1 | Capsule, Gelatin coatedOral | Sun Pharmaceutical Industries, Inc. | 63304-352 |
| Lubiprostone | Lubiprostone 24 ug/1 | Capsule, Gelatin coatedOral | Golden State Medical Supply, Inc. | 51407-745 |
| 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 |
| 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 24 ug/1 | Capsule, Gelatin coatedOral | Proficient Rx LP | 82804-001 |
| 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 24 ug/1 | Capsule, Gelatin coatedOral | Advanced Rx of Tennessee, LLC | 80425-0355 |
| Lubiprostone | Lubiprostone 8 ug/1 | Capsule, Gelatin coatedOral | Advanced Rx of Tennessee, LLC | 80425-0354 |
| 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 24 ug/1 | Capsule, Gelatin coatedOral | Direct Rx | 72189-607 |
| Amitizalubiprostone | Lubiprostone 8 ug/1 | Capsule, Gelatin coatedOral | SpecGx LLC | 23635-508 |
| Amitizalubiprostone | Lubiprostone 24 ug/1 | Capsule, Gelatin coatedOral | SpecGx LLC | 23635-524 |
| Lubiprostone | Lubiprostone 24 ug/1 | Capsule, Gelatin coatedOral | Proficient Rx LP | 71205-834 |
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