Prescription drug · ANDA
Bumetanide NDC 69238-1491
Bumetanide 2 mg/1 · Tablet · Oral · Amneal Pharmaceuticals NY LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69238-1491-1 | 69238149101 | 100 TABLET in 1 BOTTLE (69238-1491-1)Marketed from Oct 18, 2017 | |
| 69238-1491-5 | 69238149105 | 500 TABLET in 1 BOTTLE (69238-1491-5)Marketed from Oct 18, 2017 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 2 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209724
- Marketing start
- Listing expires
- Other FDA classes
- Increased Diuresis at Loop of Henle (Physiologic effect)
- Identifiers
- Product ID 69238-1491_d1961e90-3fcc-4b72-b207-6c9de6d66557SPL ID d1961e90-3fcc-4b72-b207-6c9de6d66557SPL set ID 9188ab17-8539-48a5-905f-ad35ab5a0b93RxCUI 197417, 197418, 197419UNII 0Y2S3XUQ5HUPC 0369238149111, 0369238149012, 0369238148916
- 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
N469238149101followed by a unit qualifier and the quantityPackage 69238-1491-01. 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 ANDA 209724
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 | Cardinal Health 107, LLC | 55154-3572 |
| Bumetanide | Bumetanide 1 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7016 |
| Bumetanide | Bumetanide 1 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-4345 |
| Bumetanide | Bumetanide .5 mg/1 | TabletOral | Amneal Pharmaceuticals NY LLC | 69238-1489 |
| Bumetanide | Bumetanide 1 mg/1 | TabletOral | Amneal Pharmaceuticals NY LLC | 69238-1490 |
| Bumetanide | Bumetanide 2 mg/1 | TabletOral | AvPAK | 50268-132 |
| Bumetanide | Bumetanide .5 mg/1 | TabletOral | AvPAK | 50268-130 |
| Bumetanide | Bumetanide 1 mg/1 | TabletOral | AvPAK | 50268-131 |
| Bumetanide | Bumetanide 2 mg/1 | TabletOral | A-S Medication Solutions | 50090-5663 |
| Bumetanide | Bumetanide .5 mg/1 | TabletOral | A-S Medication Solutions | 50090-5664 |
| Bumetanide | Bumetanide 1 mg/1 | TabletOral | A-S Medication Solutions | 50090-5666 |