Prescription drug · ANDA
Remifentanil Hydrochloride NDC 0143-9392
Remifentanil hydrochloride 2 mg/2mL · Injection, Powder, Lyophilized, For solution · Intravenous · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0143-9392-10 | 00143939210 | 10 VIAL in 1 CARTON (0143-9392-10) / 5 mL in 1 VIAL (0143-9392-01)Marketed from May 15, 2021 |
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)
- Remifentanil Hydrochloride
- Generic name (nonproprietary)
- remifentanil hydrochloride
- Active ingredients
- Remifentanil hydrochloride — 2 mg/2mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210594
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 0143-9392_5c5e498b-d829-4f78-bcca-466631014767SPL ID 5c5e498b-d829-4f78-bcca-466631014767SPL set ID 9d289052-1eb6-4ba2-a3ca-d2e542a052aeRxCUI 1729578, 1729584, 1729710UNII 5V444H5WIC
- Pharmacologic class
- Opioid Agonist
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
N400143939210followed by a unit qualifier and the quantityPackage 00143-9392-10. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Remifentanil Hydrochloride for injection is indicated for intravenous (IV) administration: As an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures. For continuation as an analgesic into the immediate postoperative period in adult patients under the direct supervision of an anesthesia practitioner in a postoperative anesthesia care unit or intensive care setting. As an analgesic component of monitored anesthesia care in adult patients. Remifentanil Hydrochloride for injection is an opioid agonist indicated for intravenous administration: As an analgesic agent for use during the induction and maintenance of general anesth…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210594
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 |
|---|---|---|---|---|
| Remifentanil Hydrochloride | Remifentanil hydrochloride 1 mg/mL | Injection, Powder, Lyophilized, For solutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9391 |
| Remifentanil Hydrochloride | Remifentanil hydrochloride 5 mg/5mL | Injection, Powder, Lyophilized, For solutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9393 |