Prescription drug · NDA AUTHORIZED GENERIC
Lubiprostone NDC 71205-831
Lubiprostone 8 ug/1 · Capsule, Gelatin coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-831-00 | 7120508310071205083100 | 100 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-00)Marketed from Oct 18, 2023 | |
| 71205-831-11 | 7120508311171205083111 | 1000 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-11)Marketed from Oct 18, 2023 | |
| 71205-831-30 | 7120508313071205083130 | 30 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-30)Marketed from Oct 18, 2023 | |
| 71205-831-55 | 7120508315571205083155 | 500 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-55)Marketed from Oct 18, 2023 | |
| 71205-831-60 | 7120508316071205083160 | 60 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-60)Marketed from Oct 18, 2023 | |
| 71205-831-64 | 7120508316471205083164 | 240 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-64)Marketed from Oct 18, 2023 | |
| 71205-831-67 | 7120508316771205083167 | 270 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-67)Marketed from Oct 18, 2023 | |
| 71205-831-72 | 7120508317271205083172 | 120 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-72)Marketed from Oct 18, 2023 | |
| 71205-831-78 | 7120508317871205083178 | 180 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-78)Marketed from Oct 18, 2023 | |
| 71205-831-90 | 7120508319071205083190 | 90 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-90)Marketed from Oct 18, 2023 |
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, Gelatin coated
- Route
- Oral
- Labeler
- Proficient Rx LPNDC labeler code 71205
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 021908
- Marketing start
- Listing expires
- Other FDA classes
- Chloride Channel Activators (Mechanism)
- Identifiers
- Product ID 71205-831_4aed57d0-99d8-424e-a1c7-0cd8a31a66cfSPL ID 4aed57d0-99d8-424e-a1c7-0cd8a31a66cfSPL set ID 4aed57d0-99d8-424e-a1c7-0cd8a31a66cfRxCUI 794639UNII 7662KG2R6KUPC 0371205831301
- 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
N471205083100followed by a unit qualifier and the quantityPackage 71205-0831-00. 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 ) o 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 is…
Excerpt only. Read the full label for complete information.
About NDC 71205-831
- What is NDC 71205-831?
- 71205-831 is the product NDC for Lubiprostone, Lubiprostone 8 ug/1 capsule, gelatin coated, listed with the FDA by Proficient Rx LP. It has 10 package NDCs, 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?
- Proficient Rx LP, NDC labeler code 71205. 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 NDA 021908
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 |
|---|---|---|---|---|
| Amitizalubiprostone | Lubiprostone 8 ug/1 | Capsule, Gelatin coatedOral | SpecGx LLC | 23635-508 |
| Amitizalubiprostone | Lubiprostone 24 ug/1 | Capsule, Gelatin coatedOral | SpecGx LLC | 23635-524 |
| Amitizalubiprostone | Lubiprostone 8 ug/1 | Capsule, Gelatin coatedOral | Takeda Pharmaceuticals America, Inc. | 64764-080 |
| Amitizalubiprostone | Lubiprostone 24 ug/1 | Capsule, Gelatin coatedOral | Takeda Pharmaceuticals America, Inc. | 64764-240 |
| Lubiprostone | Lubiprostone 8 ug/1 | Capsule, Gelatin coatedOral | Par Health USA, LLC | 0254-3028 |
| Lubiprostone | Lubiprostone 24 ug/1 | Capsule, Gelatin coatedOral | Par Health USA, LLC | 0254-3029 |
| Lubiprostone | Lubiprostone 8 ug/1 | Capsule, Gelatin coatedOral | SpecGx LLC | 0406-6408 |
| Lubiprostone | Lubiprostone 24 ug/1 | Capsule, Gelatin coatedOral | SpecGx LLC | 0406-6424 |
| Lubiprostone | Lubiprostone 8 ug/1 | Capsule, Gelatin coatedOral | Dr. Reddy's Laboratories Inc. | 43598-163 |
| Lubiprostone | Lubiprostone 24 ug/1 | Capsule, Gelatin coatedOral | Dr. Reddy's Laboratories Inc. | 43598-168 |
| Lubiprostone | Lubiprostone 8 ug/1 | Capsule, Gelatin coatedOral | Golden State Medical Supply, Inc. | 51407-744 |
| Lubiprostone | Lubiprostone 24 ug/1 | Capsule, Gelatin coatedOral | Golden State Medical Supply, Inc. | 51407-745 |
| Lubiprostone | Lubiprostone 8 ug/1 | Capsule, Gelatin coatedOral | Sun Pharmaceutical Industries, Inc. | 63304-351 |
| Lubiprostone | Lubiprostone 24 ug/1 | Capsule, Gelatin coatedOral | Sun Pharmaceutical Industries, Inc. | 63304-352 |
| Lubiprostone | Lubiprostone 8 ug/1 | Capsule, Gelatin coatedOral | Natco Pharma USA LLC | 69339-162 |
| Lubiprostone | Lubiprostone 24 ug/1 | Capsule, Gelatin coatedOral | Natco Pharma USA LLC | 69339-163 |
| Lubiprostone | Lubiprostone 24 ug/1 | Capsule, Gelatin coatedOral | Proficient Rx LP | 71205-832 |
| Lubiprostone | Lubiprostone 24 ug/1 | Capsule, Gelatin coatedOral | Proficient Rx LP | 71205-834 |
| Lubiprostone | Lubiprostone 24 ug/1 | Capsule, Gelatin coatedOral | Direct Rx | 72189-607 |
| Lubiprostone | Lubiprostone 8 ug/1 | Capsule, Gelatin coatedOral | Asclemed USA, Inc. | 76420-906 |
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