Prescription drug · ANDA
Flumazenil NDC 36000-148
Flumazenil .1 mg/mL · Injection · Intravenous · Baxter Healthcare Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 36000-148-10 | 36000014810 | 10 VIAL, MULTI-DOSE in 1 PACKAGE (36000-148-10) / 5 mL in 1 VIAL, MULTI-DOSEMarketed from Oct 1, 2017 |
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)
- Flumazenil
- Generic name (nonproprietary)
- flumazenil
- Active ingredients
- Flumazenil — .1 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076755
- Marketing start
- Listing expires
- Identifiers
- Product ID 36000-148_f84ae313-68b9-444b-83de-d9f50157dad2SPL ID f84ae313-68b9-444b-83de-d9f50157dad2SPL set ID 8175c1eb-80af-48f1-813c-c8f0e736d894RxCUI 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
N436000014810followed by a unit qualifier and the quantityPackage 36000-0148-10. 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)
INDICATIONS AND USAGE Adult Patients: Flumazenil injection 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 is indicated for the reversal of conscious sedation induced with benzodiazepines (see PRECAUTIONS: Pediatric Use ).
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 076755
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 | InjectionIntravenous | Baxter Healthcare Corporation | 36000-149 |
| Flumazenil | Flumazenil .1 mg/mL | InjectionIntravenous | Medical Purchasing Solutions, LLC | 71872-7206 |
| Flumazenil | Flumazenil .1 mg/mL | InjectionIntravenous | Medical Purchasing Solutions, LLC | 71872-7321 |