Prescription drug · NDA AUTHORIZED GENERIC
Bumetanide NDC 42799-119
Bumetanide .5 mg/1 · Tablet · Oral · Edenbridge Pharmaceuticals LLC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42799-119-01 | 42799011901 | 100 TABLET in 1 BOTTLE (42799-119-01)Marketed from Oct 15, 2015 |
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)
- Bumetanide
- Generic name (nonproprietary)
- bumetanide
- Active ingredients
- Bumetanide — .5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 018225
- Marketing start
- Listing expires
- Other FDA classes
- Increased Diuresis at Loop of Henle (Physiologic effect)
- Identifiers
- Product ID 42799-119_462dc93e-f284-3a48-e063-6394a90a7ce1SPL ID 462dc93e-f284-3a48-e063-6394a90a7ce1SPL set ID 32c4372e-54ea-4fc8-b9f8-827fa4c8edd3RxCUI 197417, 197418, 197419UNII 0Y2S3XUQ5HUPC 0342799120010, 0342799119014, 0342799121017
- 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
N442799011901followed by a unit qualifier and the quantityPackage 42799-0119-01. 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 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 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 NDA 018225
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 2 mg/1 | TabletOral | American Health Packaging | 60687-535 |
| Bumetanide | Bumetanide 2 mg/1 | TabletOral | Edenbridge Pharmaceuticals LLC. | 42799-121 |
| Bumetanide | Bumetanide 1 mg/1 | TabletOral | Edenbridge Pharmaceuticals LLC. | 42799-120 |
| Bumexbumetanide | Bumetanide .5 mg/1 | TabletOral | Validus Pharmaceuticals LLC | 30698-630 |
| Bumexbumetanide | Bumetanide 1 mg/1 | TabletOral | Validus Pharmaceuticals LLC | 30698-631 |
| Bumexbumetanide | Bumetanide 2 mg/1 | TabletOral | Validus Pharmaceuticals LLC | 30698-632 |
| Bumetanide | Bumetanide 1 mg/1 | TabletOral | American Health Packaging | 60687-384 |