Prescription drug · ANDA
Lubiprostone NDC 70771-1763
Lubiprostone 8 ug/1 · Capsule · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70771-1763-1 | 70771176301 | 100 CAPSULE in 1 BOTTLE (70771-1763-1)Marketed from Mar 23, 2023 | |
| 70771-1763-6 | 70771176306 | 60 CAPSULE in 1 BOTTLE (70771-1763-6)Marketed from Mar 23, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 8 ug/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Zydus Lifesciences Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214131
- Marketing start
- Listing expires
- Other FDA classes
- Chloride Channel Activators (Mechanism)
- Identifiers
- Product ID 70771-1763_570c527a-5ee5-4950-b27a-48f652af549fSPL ID 570c527a-5ee5-4950-b27a-48f652af549fSPL set ID 81f9c9de-f89d-4ab0-a8ca-18d3691e42f9RxCUI 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
N470771176301followed by a unit qualifier and the quantityPackage 70771-1763-01. 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 .
Other NDCs under ANDA 214131
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 | CapsuleOral | Zydus Pharmaceuticals USA Inc. | 70710-1641 |
| Lubiprostone | Lubiprostone 24 ug/1 | CapsuleOral | Zydus Pharmaceuticals USA Inc. | 70710-1642 |
| Lubiprostone | Lubiprostone 8 ug/1 | CapsuleOral | Asclemed USA, Inc. | 76420-777 |
| Lubiprostone | Lubiprostone 24 ug/1 | CapsuleOral | Asclemed USA, Inc. | 76420-778 |
| Lubiprostone | Lubiprostone 24 ug/1 | CapsuleOral | Zydus Lifesciences Limited | 70771-1764 |