Prescription drug · ANDA
Flumazenil NDC 0404-9793
Flumazenil .1 mg/mL · Injection, Solution · Intravenous · Henry Schein, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0404-9793-05 | 0040497930500404979305 | 1 VIAL, MULTI-DOSE in 1 BAG (0404-9793-05) / 5 mL in 1 VIAL, MULTI-DOSEMarketed from Feb 14, 2025 |
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)
- Flumazenil
- Generic name (nonproprietary)
- flumazenil
- Active ingredients
- Flumazenil — .1 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Henry Schein, Inc.NDC labeler code 0404
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078527
- Marketing start
- Listing expires
- Identifiers
- Product ID 0404-9793_bd300433-4b66-48b5-bd42-4b311b701907SPL ID bd300433-4b66-48b5-bd42-4b311b701907SPL set ID 1855bb03-392f-4a0d-8361-24fc2a0e635eRxCUI 204508UNII 40P7XK9392
- Pharmacologic class
- Benzodiazepine Antagonist
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
N400404979305followed by a unit qualifier and the quantityPackage 00404-9793-05. 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 Adult Patients Flumazenil Injection, USP is indicated for the complete or partial reversal of the sedative effects of benzodiazepines in cases where general anesthesia has been induced and/or maintained with benzodiazepines, where sedation has been produced with benzodiazepines for diagnostic and therapeutic procedures, and for the management of benzodiazepine overdose. Pediatric Patients (aged 1 to 17) Flumazenil Injection, USP is indicated for the reversal of conscious sedation induced with benzodiazepines (see PRECAUTIONS: Pediatric Use ).
Excerpt only. Read the full label for complete information.
About NDC 0404-9793
- What is NDC 0404-9793?
- 0404-9793 is the product NDC for Flumazenil, Flumazenil .1 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?
- Flumazenil.
- What is the active ingredient?
- Flumazenil.
- 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 Flumazenil?
- 20 other product NDCs are listed under this name. See all Flumazenil NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Flumazenil products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Flumazenil | Flumazenil .1 mg/mL | Injection, SolutionIntravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1699 | 51662-1699-03 |
| Flumazenil | Flumazenil .1 mg/mL | Injection, SolutionIntravenous | Henry Schein, Inc. | 0404-9794 | 00404-9794-10 |
| Flumazenil | Flumazenil .1 mg/mL | Injection, SolutionIntravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1579 | 51662-1579-03 |
| Flumazenil | Flumazenil .1 mg/mL | Injection, SolutionIntravenous | HF Acquisition Co. LLC, DBA HealthFirst | 51662-1254 | 51662-1254-0151662-1254-03 |
| Flumazenil | Flumazenil .1 mg/mL | Injection, SolutionIntravenous | HF Acquisition Co. LLC, DBA Health First | 51662-1253 | 51662-1253-0151662-1253-03 |
| Flumazenil | Flumazenil .1 mg/mL | InjectionIntravenous | Baxter Healthcare Corporation | 36000-148 | 36000-0148-10 |
| Flumazenil | Flumazenil .1 mg/mL | InjectionIntravenous | Baxter Healthcare Corporation | 36000-149 | 36000-0149-10 |
| Flumazenil | Flumazenil .1 mg/mL | InjectionIntravenous | Medical Purchasing Solutions, LLC | 71872-7206 | 71872-7206-01 |
| Flumazenil | Flumazenil .1 mg/mL | InjectionIntravenous | Medical Purchasing Solutions, LLC | 71872-7321 | 71872-7321-01 |
| Flumazenil | Flumazenil .1 mg/mL | Injection, SolutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9683 | 00143-9683-10 |
Other NDCs under ANDA 078527
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 |
|---|---|---|---|---|
| Flumazenil | Flumazenil .1 mg/mL | Injection, SolutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9683 |
| Flumazenil | Flumazenil .1 mg/mL | Injection, SolutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9684 |
| Flumazenil | Flumazenil .1 mg/mL | Injection, SolutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9783 |
| Flumazenil | Flumazenil .1 mg/mL | Injection, SolutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9784 |
| Flumazenil | Flumazenil .1 mg/mL | Injection, SolutionIntravenous | Henry Schein, Inc. | 0404-9794 |
| Flumazenil | Flumazenil .1 mg/mL | Injection, SolutionIntravenous | A-S Medication Solutions | 50090-1337 |
| Flumazenil | Flumazenil .1 mg/mL | Injection, SolutionIntravenous | HF Acquisition Co. LLC, DBA Health First | 51662-1253 |
| Flumazenil | Flumazenil .1 mg/mL | Injection, SolutionIntravenous | HF Acquisition Co. LLC, DBA HealthFirst | 51662-1254 |
| Flumazenil | Flumazenil .1 mg/mL | Injection, SolutionIntravenous | Medical Purchasing Solutions, LLC | 71872-7008 |
| Flumazenil | Flumazenil .1 mg/mL | Injection, SolutionIntravenous | Medical Purchasing Solutions, LLC | 71872-7038 |
| Flumazenil | Flumazenil .1 mg/mL | Injection, SolutionIntravenous | ProPharma Distribution | 84549-783 |
| Flumazenil | Flumazenil .1 mg/mL | Injection, SolutionIntravenous | ProPharma Distribution | 84549-784 |