Prescription drug · ANDA
Bumetanide NDC 0641-6008
Bumetanide .25 mg/mL · Injection, Solution · Intramuscular, Intravenous · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0641-6008-10 | 00641600810 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0641-6008-10) / 4 mL in 1 VIAL, SINGLE-DOSE (0641-6008-01)Marketed from Apr 30, 2008 |
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)
- Bumetanide
- Generic name (nonproprietary)
- bumetanide
- Active ingredients
- Bumetanide — .25 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intramuscular, Intravenous
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 079196
- Marketing start
- Listing expires
- Other FDA classes
- Increased Diuresis at Loop of Henle (Physiologic effect)
- Identifiers
- Product ID 0641-6008_fd0b9cd7-b786-44b0-8dc7-02ffd38576a4SPL ID fd0b9cd7-b786-44b0-8dc7-02ffd38576a4SPL set ID 681b5e9d-e2c7-4f29-aaad-e06d4a528c11RxCUI 282486, 1727569UNII 0Y2S3XUQ5H
- Pharmacologic class
- Loop Diuretic
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
N400641600810followed by a unit qualifier and the quantityPackage 00641-6008-10. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 079196
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 |
|---|---|---|---|---|
| Bumetanide | Bumetanide .25 mg/mL | InjectionIntramuscular, Intravenous | Hikma Pharmaceuticals USA Inc. | 0641-6284 |
| Bumetanide | Bumetanide .25 mg/mL | InjectionIntramuscular, Intravenous | Hikma Pharmaceuticals USA Inc. | 0641-6285 |
| Bumetanide | Bumetanide .25 mg/mL | InjectionIntramuscular, Intravenous | Civica, Inc. | 72572-040 |
| Bumetanide | Bumetanide .25 mg/mL | InjectionIntramuscular, Intravenous | Civica, Inc. | 72572-041 |
| Bumetanide | Bumetanide .25 mg/mL | InjectionIntramuscular, Intravenous | Cardinal Health 107, LLC | 55154-5131 |
| Bumetanide | Bumetanide .25 mg/mL | Injection, SolutionIntramuscular, Intravenous | Hikma Pharmaceuticals USA Inc. | 0641-6007 |
| Bumetanide | Bumetanide .25 mg/mL | InjectionIntramuscular, Intravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1449 |