Prescription drug · NDA
Amidate (Etomidate) NDC 0404-9811
Etomidate 2 mg/mL · Injection, Solution · Intravenous · Henry Schein, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0404-9811-10 | 0040498111000404981110 | 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9811-10) / 10 mL in 1 VIAL, SINGLE-DOSEMarketed from Jan 6, 2022 |
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)
- Amidate
- Generic name (nonproprietary)
- etomidate
- Active ingredients
- Etomidate — 2 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Henry Schein, Inc.NDC labeler code 0404
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 018227
- Marketing start
- Listing expires
- Other FDA classes
- General Anesthesia (Physiologic effect)
- Identifiers
- Product ID 0404-9811_53c329b0-76c1-42c8-96d3-f01088ce5bd8SPL ID 53c329b0-76c1-42c8-96d3-f01088ce5bd8SPL set ID eb63c7d7-5eca-4751-be51-45cf4d7715aaRxCUI 1654006, 1654009UNII 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
N400404981110followed by a unit qualifier and the quantityPackage 00404-9811-10. 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 AMIDATE is indicated by intravenous injection for the induction of general anesthesia. When considering use of AMIDATE, 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 AMIDATE 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 0404-9811
- What is NDC 0404-9811?
- 0404-9811 is the product NDC for Amidate (etomidate), Etomidate 2 mg/mL injection, solution, listed with the FDA by Henry Schein, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Amidate (Etomidate).
- What is the active ingredient?
- Etomidate.
- Who is the labeler?
- Henry Schein, Inc., NDC labeler code 0404. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Amidate?
- 1 other product NDC are listed under this name. See all Amidate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Amidate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Amidateetomidate | Etomidate 2 mg/mL | Injection, SolutionIntravenous | Hospira, Inc. | 0409-6695 | 00409-6695-0100409-6695-02 |
Other NDCs under NDA 018227
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 |
|---|---|---|---|---|
| Amidateetomidate | Etomidate 2 mg/mL | Injection, SolutionIntravenous | Hospira, Inc. | 0409-6695 |
| Amidate(Tm) Etomidate | Etomidate 2 mg/mL | Injection, SolutionIntravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1459 |