Prescription drug · ANDA
Etomidate NDC 65219-445
Etomidate 2 mg/mL · Injection, Solution · Intravenous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65219-445-10 | 65219044510 | 10 VIAL, SINGLE-DOSE in 1 CARTON (65219-445-10) / 10 mL in 1 VIAL, SINGLE-DOSE (65219-445-01)Marketed from Aug 1, 2021 |
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)
- Etomidate
- Generic name (nonproprietary)
- etomidate
- Active ingredients
- Etomidate — 2 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Fresenius Kabi USA, LLCNDC labeler code 65219
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215028
- Marketing start
- Listing expires
- Other FDA classes
- General Anesthesia (Physiologic effect)
- Identifiers
- Product ID 65219-445_30488a7e-ea9e-4a27-95a9-a07149c50282SPL ID 30488a7e-ea9e-4a27-95a9-a07149c50282SPL set ID d07efb9e-5264-461d-96d8-e11fa71c5751RxCUI 1654006, 1654008UNII Z22628B598
- Pharmacologic class
- General Anesthetic
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
N465219044510followed by a unit qualifier and the quantityPackage 65219-0445-10. 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)
INDICATIONS AND USAGE Etomidate Injection USP is indicated by intravenous injection for the induction of general anesthesia. When considering use of etomidate, the usefulness of its hemodynamic properties (see CLINICAL PHARMACOLOGY ) should be weighed against the high frequency of transient skeletal muscle movements (see ADVERSE REACTIONS ). Intravenous etomidate is also indicated for the supplementation of subpotent anesthetic agents, such as nitrous oxide in oxygen, during maintenance of anesthesia for short operative procedures such as dilation and curettage or cervical conization.
Excerpt only. Read the full label for complete information.
About NDC 65219-445
- What is NDC 65219-445?
- 65219-445 is the product NDC for Etomidate, Etomidate 2 mg/mL injection, solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Etomidate.
- What is the active ingredient?
- Etomidate.
- Who is the labeler?
- Fresenius Kabi USA, LLC, NDC labeler code 65219. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Etomidate?
- 22 other product NDCs are listed under this name. See all Etomidate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Etomidate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Etomidate | Etomidate 2 mg/mL | Injection, SolutionIntravenous | Caplin Steriles Limited | 65145-127 | 65145-0127-10 |
| Etomidate | Etomidate 2 mg/mL | Injection, SolutionIntravenous | Caplin Steriles Limited | 65145-128 | 65145-0128-10 |
| Etomidate | Etomidate 2 mg/mL | Injection, SolutionIntravenous | Armas Pharmaceuticals Inc. | 72485-508 | 72485-0508-10 |
| Etomidate | Etomidate 2 mg/mL | Injection, SolutionIntravenous | Armas Pharmaceuticals Inc. | 72485-509 | 72485-0509-10 |
| Etomidate | Etomidate 40 mg/20mL | Injection, SolutionIntravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1542 | 51662-1542-01 |
| Etomidate | Etomidate 2 mg/mL | InjectionIntravenous | Civica, Inc. | 72572-160 | 72572-0160-10 |
| Etomidate | Etomidate 2 mg/mL | InjectionIntravenous | Civica, Inc. | 72572-161 | 72572-0161-10 |
| Etomidate | Etomidate 2 mg/mL | Injection, SolutionIntravenous | Fresenius Kabi USA, LLC | 65219-447 | 65219-0447-20 |
| Etomidate | Etomidate 2 mg/mL | InjectionIntravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1485 | 51662-1485-01 |
| Etomidateetomidate injection | Etomidate 2 mg/mL | SolutionIntravenous | Fosun Pharma USA Inc | 72266-146 | 72266-0146-10 |
Other NDCs under ANDA 215028
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 |
|---|---|---|---|---|
| Etomidate | Etomidate 2 mg/mL | Injection, SolutionIntravenous | Armas Pharmaceuticals Inc. | 72485-508 |
| Etomidate | Etomidate 2 mg/mL | Injection, SolutionIntravenous | Armas Pharmaceuticals Inc. | 72485-509 |
| Etomidate | Etomidate 2 mg/mL | Injection, SolutionIntravenous | Caplin Steriles Limited | 65145-127 |
| Etomidate | Etomidate 2 mg/mL | Injection, SolutionIntravenous | Caplin Steriles Limited | 65145-128 |
| Etomidate | Etomidate 2 mg/mL | Injection, SolutionIntravenous | Fresenius Kabi USA, LLC | 65219-447 |