Prescription drug · NDA
Cleviprex (Clevidipine) NDC 18124-011
Clevidipine .5 mg/mL · Emulsion · Intravenous · Fresenius Kabi Austria GmbH
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 18124-011-00 | 18124001100 | 10 CARTON in 1 CARTON (18124-011-00) / 1 VIAL, SINGLE-USE in 1 CARTON / 100 mL in 1 VIAL, SINGLE-USEMarketed from Sep 15, 2008 | |
| 18124-011-25 | 18124001125 | 4 CARTON in 1 CARTON (18124-011-25) / 1 VIAL, SINGLE-USE in 1 CARTON / 250 mL in 1 VIAL, SINGLE-USEMarketed from Sep 15, 2008 | |
| 18124-011-50 | 18124001150 | 10 CARTON in 1 CARTON (18124-011-50) / 1 VIAL, SINGLE-USE in 1 CARTON / 50 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)
- clevidipine
- Active ingredients
- Clevidipine — .5 mg/mL
- Dosage form
- Emulsion
- Route
- Intravenous
- Labeler
- Fresenius Kabi Austria GmbHNDC labeler code 18124
- 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 18124-011_0ef540ec-3e55-44d0-b8b9-e70407a54748SPL ID 0ef540ec-3e55-44d0-b8b9-e70407a54748SPL set ID a6826aa3-fabb-4ff1-a7a3-cd4c34e3a330RxCUI 1790239, 1790242, 1790245, 1790246, 1790247, 1790248UNII 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
N418124001100followed by a unit qualifier and the quantityPackage 18124-0011-00. 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)
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 18124-011
- What is NDC 18124-011?
- 18124-011 is the product NDC for Cleviprex (clevidipine), Clevidipine .5 mg/mL emulsion, listed with the FDA by Fresenius Kabi Austria GmbH. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cleviprex (Clevidipine).
- What is the active ingredient?
- Clevidipine.
- Who is the labeler?
- Fresenius Kabi Austria GmbH, NDC labeler code 18124. 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 |
| Cleviprexclevipidine | Clevidipine .5 mg/mL | EmulsionIntravenous | Chiesi USA, Inc. | 10122-611 | 10122-0611-10 |
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 |
| Cleviprexclevipidine | Clevidipine .5 mg/mL | EmulsionIntravenous | Chiesi USA, Inc. | 10122-611 |