Prescription drug · NDA AUTHORIZED GENERIC
Lubiprostone NDC 69339-163
Lubiprostone 24 ug/1 · Capsule, Gelatin coated · Oral · Natco Pharma USA LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69339-163-17 | 69339016317 | 40 BLISTER PACK in 1 CARTON (69339-163-17) / 1 CAPSULE, GELATIN COATED in 1 BLISTER PACK (69339-163-98)Marketed from Oct 17, 2022 |
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)
- Lubiprostone
- Generic name (nonproprietary)
- lubiprostone
- Active ingredients
- Lubiprostone — 24 ug/1
- Dosage form
- Capsule, Gelatin coated
- Route
- Oral
- Labeler
- Natco Pharma 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 69339-163_8eaefb22-646d-468c-9b62-a1c8585440e2SPL ID 8eaefb22-646d-468c-9b62-a1c8585440e2SPL set ID 10c7b62d-6c39-453c-8d9a-2f441725bc3bRxCUI 616578, 794639UNII 7662KG2R6KUPC 0369339163177
- 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
N469339016317followed by a unit qualifier and the quantityPackage 69339-0163-17. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
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 24 ug/1 | Capsule, Gelatin coatedOral | Par Health USA, LLC | 0254-3029 |
| Lubiprostone | Lubiprostone 8 ug/1 | Capsule, Gelatin coatedOral | Natco Pharma USA LLC | 69339-162 |
| 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 |
Showing 20 of 24.