Prescription drug · ANDA
Lubiprostone NDC 82804-304
Lubiprostone 24 ug/1 · Capsule, Gelatin coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82804-304-60 | 82804030460 | 60 CAPSULE, GELATIN COATED in 1 BOTTLE (82804-304-60)Marketed from Jul 21, 2026 |
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
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209920
- Marketing start
- Listing expires
- Other FDA classes
- Chloride Channel Activators (Mechanism)
- Identifiers
- Product ID 82804-304_5fd683a5-87ff-42b8-a8c8-fff81625f67fSPL ID 5fd683a5-87ff-42b8-a8c8-fff81625f67fSPL set ID 5fd683a5-87ff-42b8-a8c8-fff81625f67fRxCUI 616578UNII 7662KG2R6KUPC 0382804304608
- 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
N482804030460followed by a unit qualifier and the quantityPackage 82804-0304-60. 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)
Lubiprostone capsules are 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 ) o Limitations of Use: Effectiveness of lubiprostone capsules 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 Adul…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 209920
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 | American Health Packaging | 60687-816 |
| Lubiprostone | Lubiprostone 24 ug/1 | Capsule, Gelatin coatedOral | American Health Packaging | 60687-827 |
| Amitzalubiprostone | Lubiprostone 8 ug/1 | Capsule, Gelatin coatedOral | Direct_Rx | 72189-410 |
| Lubiprostone | Lubiprostone 24 ug/1 | Capsule, Gelatin coatedOral | Teva Pharmaceuticals, Inc. | 0480-4138 |
| Lubiprostone | Lubiprostone 8 ug/1 | Capsule, Gelatin coatedOral | Teva Pharmaceuticals, Inc. | 0480-3479 |