Prescription drug · NDA
Cleviprex (Clevipidine) NDC 10122-611
Clevidipine .5 mg/mL · Emulsion · Intravenous · Chiesi USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 10122-611-10 | 1012206111010122061110 | 10 CARTON in 1 CARTON (10122-611-10) / 1 VIAL, SINGLE-USE in 1 CARTON (10122-611-01) / 100 mL in 1 VIAL, SINGLE-USEMarketed from Sep 15, 2008 |
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)
- Cleviprex
- Generic name (nonproprietary)
- clevipidine
- Active ingredients
- Clevidipine — .5 mg/mL
- Dosage form
- Emulsion
- Route
- Intravenous
- Labeler
- Chiesi USA, Inc.NDC labeler code 10122
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022156
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Dihydropyridines (Chemical structure)
- Identifiers
- Product ID 10122-611_e472cde4-d29e-44b2-b1ca-a6f4fcc01b1dSPL ID e472cde4-d29e-44b2-b1ca-a6f4fcc01b1dSPL set ID f9290625-b723-4eda-bab8-a97bef6041f6RxCUI 1790239, 1790242, 1790245, 1790246UNII 19O2GP3B7Q
- Pharmacologic class
- Dihydropyridine Calcium Channel Blocker
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N410122061110followed by a unit qualifier and the quantityPackage 10122-0611-10. 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)
Cleviprex is indicated for the reduction of blood pressure when oral therapy is not feasible or not desirable. Cleviprex is a dihydropyridine calcium channel blocker indicated for the reduction of blood pressure when oral therapy is not feasible or not desirable. (1)
Excerpt only. Read the full label for complete information.
About NDC 10122-611
- What is NDC 10122-611?
- 10122-611 is the product NDC for Cleviprex (clevipidine), Clevidipine .5 mg/mL emulsion, listed with the FDA by Chiesi USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cleviprex (Clevipidine).
- What is the active ingredient?
- Clevidipine.
- Who is the labeler?
- Chiesi USA, Inc., NDC labeler code 10122. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cleviprex?
- 2 other product NDCs are listed under this name. See all Cleviprex NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cleviprex products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Cleviprexclevipidine | Clevidipine .5 mg/mL | EmulsionIntravenous | Chiesi USA, Inc. | 10122-610 | 10122-0610-10 |
| Cleviprexclevidipine | Clevidipine .5 mg/mL | EmulsionIntravenous | Fresenius Kabi Austria GmbH | 18124-011 | 18124-0011-0018124-0011-2518124-0011-50 |
Other NDCs under NDA 022156
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 |
|---|---|---|---|---|
| Cleviprexclevipidine | Clevidipine .5 mg/mL | EmulsionIntravenous | Chiesi USA, Inc. | 10122-610 |
| Cleviprexclevidipine | Clevidipine .5 mg/mL | EmulsionIntravenous | Fresenius Kabi Austria GmbH | 18124-011 |