Prescription drug · ANDA
Lubiprostone NDC 76420-777
Lubiprostone 8 ug/1 · Capsule · Oral · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-777-01 | 76420077701 | 100 CAPSULE in 1 BOTTLE (76420-777-01)Marketed from Feb 7, 2025 | |
| 76420-777-30 | 76420077730 | 30 CAPSULE in 1 BOTTLE (76420-777-30)Marketed from Feb 7, 2025 | |
| 76420-777-60 | 76420077760 | 60 CAPSULE in 1 BOTTLE (76420-777-60)Marketed from Feb 7, 2025 | |
| 76420-777-90 | 76420077790 | 90 CAPSULE in 1 BOTTLE (76420-777-90)Marketed from Feb 7, 2025 |
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 — 8 ug/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Asclemed USA, Inc.
- 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 76420-777_2d872107-0284-f85f-e063-6394a90a6258SPL ID 2d872107-0284-f85f-e063-6394a90a6258SPL set ID 5797e57c-4e87-48d9-b16d-992f64db594fRxCUI 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
N476420077701followed by a unit qualifier and the quantityPackage 76420-0777-01. 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 .
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 capsules a…
Excerpt only. Read the full label for complete information.
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 24 ug/1 | CapsuleOral | Asclemed USA, Inc. | 76420-778 |
| Lubiprostone | Lubiprostone 24 ug/1 | CapsuleOral | Zydus Lifesciences Limited | 70771-1764 |
| Lubiprostone | Lubiprostone 8 ug/1 | CapsuleOral | Zydus Lifesciences Limited | 70771-1763 |