Prescription drug · ANDA
Lubiprostone NDC 72603-288
Lubiprostone .008 mg/1 · Capsule · Oral · Northstar Rx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72603-288-01 | 72603028801 | 60 CAPSULE in 1 BOTTLE (72603-288-01)Marketed from Jul 1, 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 — .008 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Northstar Rx LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218640
- Marketing start
- Listing expires
- Other FDA classes
- Chloride Channel Activators (Mechanism)
- Identifiers
- Product ID 72603-288_4d72c56c-4948-4cd4-afc4-e1e0d59622a5SPL ID 4d72c56c-4948-4cd4-afc4-e1e0d59622a5SPL set ID 1626ac65-ea12-421b-9780-bfdb50a39e1aRxCUI 616578, 794639UNII 7662KG2R6KUPC 0372603289015, 0372603288018
- 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
N472603028801followed by a unit qualifier and the quantityPackage 72603-0288-01. 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)
1. INDICATIONS AND USAGE Lubiprostone capsules 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) 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 Constipatio…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 218640
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 .024 mg/1 | CapsuleOral | Northstar Rx LLC | 72603-289 |
| Lubiprostone | Lubiprostone .008 mg/1 | CapsuleOral | Camber Pharmaceuticals, Inc. | 31722-403 |
| Lubiprostone | Lubiprostone .024 mg/1 | CapsuleOral | Camber Pharmaceuticals, Inc. | 31722-404 |