Prescription drug · ANDA
Lubiprostone NDC 0480-3479
Lubiprostone 8 ug/1 · Capsule, Gelatin coated · Oral · Teva Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0480-3479-06 | 0048034790600480347906 | 60 CAPSULE, GELATIN COATED in 1 BOTTLE (0480-3479-06)Marketed from Jan 3, 2023 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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, Gelatin coated
- Route
- Oral
- Labeler
- Teva Pharmaceuticals, Inc.NDC labeler code 0480
- 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 0480-3479_22f53da2-2fb9-411d-baad-fef011383f6fSPL ID 22f53da2-2fb9-411d-baad-fef011383f6fSPL set ID e17b521e-2c25-4bef-82f9-7916fa79bca4RxCUI 616578, 794639UNII 7662KG2R6KUPC 0304804138069, 0304803479064
- 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
N400480347906followed by a unit qualifier and the quantityPackage 00480-3479-06. 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 ) 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 Adults Lubip…
Excerpt only. Read the full label for complete information.
About NDC 0480-3479
- What is NDC 0480-3479?
- 0480-3479 is the product NDC for Lubiprostone, Lubiprostone 8 ug/1 capsule, gelatin coated, listed with the FDA by Teva Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lubiprostone.
- What is the active ingredient?
- Lubiprostone.
- Who is the labeler?
- Teva Pharmaceuticals, Inc., NDC labeler code 0480. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Lubiprostone?
- 37 other product NDCs are listed under this name. See all Lubiprostone NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lubiprostone products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lubiprostone | Lubiprostone 8 ug/1 | Capsule, Gelatin coatedOral | American Health Packaging | 60687-816 | 60687-0816-32 |
| Lubiprostone | Lubiprostone 24 ug/1 | Capsule, Gelatin coatedOral | American Health Packaging | 60687-827 | 60687-0827-32 |
| Lubiprostone | Lubiprostone .008 mg/1 | CapsuleOral | Northstar Rx LLC | 72603-288 | 72603-0288-01 |
| Lubiprostone | Lubiprostone .024 mg/1 | CapsuleOral | Northstar Rx LLC | 72603-289 | 72603-0289-01 |
| Lubiprostone | Lubiprostone .008 mg/1 | CapsuleOral | Camber Pharmaceuticals, Inc. | 31722-403 | 31722-0403-60 |
| Lubiprostone | Lubiprostone .024 mg/1 | CapsuleOral | Camber Pharmaceuticals, Inc. | 31722-404 | 31722-0404-60 |
| Lubiprostone | Lubiprostone 24 ug/1 | Capsule, Gelatin coatedOral | Direct Rx | 72189-607 | 72189-0607-60 |
| Lubiprostone | Lubiprostone 8 ug/1 | Capsule, Gelatin coatedOral | SpecGx LLC | 0406-6408 | 00406-6408-60 |
| Lubiprostone | Lubiprostone 24 ug/1 | Capsule, Gelatin coatedOral | SpecGx LLC | 0406-6424 | 00406-6424-60 |
| Lubiprostone | Lubiprostone 8 ug/1 | Capsule, Gelatin coatedOral | Advanced Rx of Tennessee, LLC | 80425-0354 | 80425-0354-02 |
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 |
|---|---|---|---|---|
| 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 | American Health Packaging | 60687-816 |
| Lubiprostone | Lubiprostone 24 ug/1 | Capsule, Gelatin coatedOral | American Health Packaging | 60687-827 |
| Lubiprostone | Lubiprostone 24 ug/1 | Capsule, Gelatin coatedOral | Proficient Rx LP | 82804-304 |