Prescription drug · ANDA
Bumetanide NDC 0185-0128
Bumetanide .5 mg/1 · Tablet · Oral · Sandoz Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0185-0128-01 | 00185012801 | 100 TABLET in 1 BOTTLE (0185-0128-01)Marketed from Nov 21, 1996 | |
| 0185-0128-05 | 00185012805 | 500 TABLET in 1 BOTTLE (0185-0128-05)Marketed from Nov 21, 1996 |
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 — .5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Sandoz Inc
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074700
- Marketing start
- Listing expires
- Other FDA classes
- Increased Diuresis at Loop of Henle (Physiologic effect)
- Identifiers
- Product ID 0185-0128_c6f31ac9-10d1-4d92-882e-836de10e1ce6SPL ID c6f31ac9-10d1-4d92-882e-836de10e1ce6SPL set ID 05cb961d-ac33-4bcf-b04e-411e496c43c1RxCUI 197417, 197418, 197419UNII 0Y2S3XUQ5HUPC 0301850128013, 0301850129010, 0301850130016
- 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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400185012801followed by a unit qualifier and the quantityPackage 00185-0128-01. 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 Bumetanide tablets, USP are indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome. Almost equal diuretic response occurs after oral and parenteral administration of bumetanide. Therefore, if impaired gastrointestinal absorption is suspected or oral administration is not practical, bumetanide should be given by the intramuscular or intravenous route. Successful treatment with bumetanide tablets, USP following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 074700
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 1 mg/1 | TabletOral | Proficient Rx LP | 82804-119 |
| Bumetanide | Bumetanide 2 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2197 |
| Bumetanide | Bumetanide .5 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2195 |
| Bumetanide | Bumetanide 1 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2196 |
| Bumetanide | Bumetanide 1 mg/1 | TabletOral | Sandoz Inc | 0185-0129 |
| Bumetanide | Bumetanide 2 mg/1 | TabletOral | Sandoz Inc | 0185-0130 |
| Bumetanide | Bumetanide 1 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2670 |
| Bumetanide | Bumetanide 1 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2920 |
| Bumetanide | Bumetanide 1 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-288 |
| Bumetanide | Bumetanide 1 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-4968 |
| Bumetanide | Bumetanide 2 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2705 |
| Bumetanide | Bumetanide 2 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2998 |
| Bumetanide | Bumetanide .5 mg/1 | TabletOral | Sandoz Inc | 0781-8099 |
| Bumetanide | Bumetanide 1 mg/1 | TabletOral | Sandoz Inc | 0781-8113 |
| Bumetanide | Bumetanide 2 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4387 |
| Bumetanide | Bumetanide 2 mg/1 | TabletOral | Sandoz Inc | 0781-8160 |
| Bumetanide | Bumetanide 2 mg/1 | TabletOral | A-S Medication Solutions | 50090-6304 |
| Bumetanide | Bumetanide .5 mg/1 | TabletOral | A-S Medication Solutions | 50090-6308 |
| Bumetanide | Bumetanide 1 mg/1 | TabletOral | A-S Medication Solutions | 50090-6345 |