Prescription drug · ANDA
Alvimopan NDC 0254-3012
Alvimopan 12 mg/1 · Capsule · Oral · Par Health USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0254-3012-55 | 0025430125500254301255 | 6 BLISTER PACK in 1 CARTON (0254-3012-55) / 5 CAPSULE in 1 BLISTER PACKMarketed from May 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)
- Alvimopan
- Generic name (nonproprietary)
- alvimopan
- Active ingredients
- Alvimopan — 12 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Par Health USA, LLCNDC labeler code 0254
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216843
- Marketing start
- Listing expires
- Other FDA classes
- Opioid Antagonists (Mechanism)
- Identifiers
- Product ID 0254-3012_d43941f1-7b52-4e7a-a560-9a8e28a7ac65SPL ID d43941f1-7b52-4e7a-a560-9a8e28a7ac65SPL set ID 1cd584de-b704-4d26-8451-e3247ffb8d08RxCUI 799835UNII 677C126AET
- Pharmacologic class
- Opioid Antagonist
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
N400254301255followed by a unit qualifier and the quantityPackage 00254-3012-55. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Alvimopan capsules are indicated to accelerate the time to upper and lower gastrointestinal recovery following surgeries that include partial bowel resection with primary anastomosis. Alvimopan capsules are an opioid antagonist indicated to accelerate the time to upper and lower gastrointestinal recovery following surgeries that include partial bowel resection with primary anastomosis. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 0254-3012
- What is NDC 0254-3012?
- 0254-3012 is the product NDC for Alvimopan, Alvimopan 12 mg/1 capsule, listed with the FDA by Par Health USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Alvimopan.
- What is the active ingredient?
- Alvimopan.
- Who is the labeler?
- Par Health USA, LLC, NDC labeler code 0254. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Alvimopan?
- 2 other product NDCs are listed under this name. See all Alvimopan NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Alvimopan products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Alvimopan | Alvimopan 12 mg/1 | CapsuleOral | Hikma Pharmaceuticals USA Inc. | 0054-0668 | 00054-0668-82 |
| Alvimopan | Alvimopan 12 mg/1 | CapsuleOral | Golden State Medical Supply, Inc. | 51407-870 | 51407-0870-33 |