Prescription drug · ANDA
Flumazenil NDC 0143-9684
Flumazenil .1 mg/mL · Injection, Solution · Intravenous · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0143-9684-10 | 00143968410 | 10 VIAL, MULTI-DOSE in 1 BOX (0143-9684-10) / 5 mL in 1 VIAL, MULTI-DOSE (0143-9684-01)Marketed from Mar 23, 2009 |
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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078527
- Marketing start
- Listing expires
- Identifiers
- Product ID 0143-9684_0ecaa504-add6-48df-817f-e5d5eef9fc8bSPL ID 0ecaa504-add6-48df-817f-e5d5eef9fc8bSPL set ID 436f5616-9626-4b6a-9deb-2986444179d0RxCUI 204508UNII 40P7XK9392UPC 0301439683100, 0301439684107
- 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
N400143968410followed by a unit qualifier and the quantityPackage 00143-9684-10. 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, 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.
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 | Medical Purchasing Solutions, LLC | 71872-7038 |
| Flumazenil | Flumazenil .1 mg/mL | Injection, SolutionIntravenous | Henry Schein, Inc. | 0404-9793 |
| Flumazenil | Flumazenil .1 mg/mL | Injection, SolutionIntravenous | Henry Schein, Inc. | 0404-9794 |
| Flumazenil | Flumazenil .1 mg/mL | Injection, SolutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9683 |
| 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 | 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 | A-S Medication Solutions | 50090-1337 |
| Flumazenil | Flumazenil .1 mg/mL | Injection, SolutionIntravenous | ProPharma Distribution | 84549-783 |
| Flumazenil | Flumazenil .1 mg/mL | Injection, SolutionIntravenous | Medical Purchasing Solutions, LLC | 71872-7008 |
| Flumazenil | Flumazenil .1 mg/mL | Injection, SolutionIntravenous | ProPharma Distribution | 84549-784 |