Prescription drug · NDA
Ultiva (Remifentanil hydrochloride) NDC 72078-034
Remifentanil hydrochloride 1 mg/mL · Injection, Powder, Lyophilized, For solution · Intravenous · Mylan Institutional LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72078-034-01 | 72078003401 | 10 VIAL, GLASS in 1 CARTON (72078-034-01) / 3 mL in 1 VIAL, GLASS (72078-034-00)Marketed from Jun 21, 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)
- Ultiva
- Generic name (nonproprietary)
- remifentanil hydrochloride
- Active ingredients
- Remifentanil hydrochloride — 1 mg/mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Mylan Institutional LLCNDC labeler code 72078
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020630
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 72078-034_f41b6542-9305-43e7-bbbc-52c7ee2cb0dcSPL ID f41b6542-9305-43e7-bbbc-52c7ee2cb0dcSPL set ID 8b4c8696-e23e-4c51-a4d2-babab5bd945aRxCUI 1729578, 1729581, 1729584, 1729586, 1729710, 1729712UNII 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
N472078003401followed by a unit qualifier and the quantityPackage 72078-0034-01. 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)
ULTIVA 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. ULTIVA is an opioid agonist indicated for intravenous administration: • As an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures. ( 1 ) • For co…
Excerpt only. Read the full label for complete information.
About NDC 72078-034
- What is NDC 72078-034?
- 72078-034 is the product NDC for Ultiva (remifentanil hydrochloride), Remifentanil hydrochloride 1 mg/mL injection, powder, lyophilized, for solution, listed with the FDA by Mylan Institutional LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ultiva (Remifentanil Hydrochloride).
- What is the active ingredient?
- Remifentanil hydrochloride.
- Who is the labeler?
- Mylan Institutional LLC, NDC labeler code 72078. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ultiva?
- 5 other product NDCs are listed under this name. See all Ultiva NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ultiva products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ultivaremifentanil hydrochloride | Remifentanil hydrochloride 1 mg/mL | Injection, Powder, Lyophilized, For solutionIntravenous | Mylan Institutional LLC | 72078-036 | 72078-0036-05 |
| Ultivaremifentanil hydrochloride | Remifentanil hydrochloride 1 mg/mL | Injection, Powder, Lyophilized, For solutionIntravenous | Mylan Institutional LLC | 72078-035 | 72078-0035-02 |
| Ultivaremifentanil hydrochloride | Remifentanil hydrochloride 1 mg/mL | Injection, Powder, Lyophilized, For solutionIntravenous | Mylan Institutional LLC | 67457-912 | 67457-0912-01 |
| Ultivaremifentanil hydrochloride | Remifentanil hydrochloride 1 mg/mL | Injection, Powder, Lyophilized, For solutionIntravenous | Mylan Institutional LLC | 67457-913 | 67457-0913-02 |
| Ultivaremifentanil hydrochloride | Remifentanil hydrochloride 1 mg/mL | Injection, Powder, Lyophilized, For solutionIntravenous | Mylan Institutional LLC | 67457-914 | 67457-0914-05 |
Other NDCs under NDA 020630
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 |
|---|---|---|---|---|
| Ultivaremifentanil hydrochloride | Remifentanil hydrochloride 1 mg/mL | Injection, Powder, Lyophilized, For solutionIntravenous | Mylan Institutional LLC | 72078-035 |
| Ultivaremifentanil hydrochloride | Remifentanil hydrochloride 1 mg/mL | Injection, Powder, Lyophilized, For solutionIntravenous | Mylan Institutional LLC | 72078-036 |
| Ultivaremifentanil hydrochloride | Remifentanil hydrochloride 1 mg/mL | Injection, Powder, Lyophilized, For solutionIntravenous | Mylan Institutional LLC | 67457-912 |
| Ultivaremifentanil hydrochloride | Remifentanil hydrochloride 1 mg/mL | Injection, Powder, Lyophilized, For solutionIntravenous | Mylan Institutional LLC | 67457-913 |
| Ultivaremifentanil hydrochloride | Remifentanil hydrochloride 1 mg/mL | Injection, Powder, Lyophilized, For solutionIntravenous | Mylan Institutional LLC | 67457-914 |