Prescription drug · ANDA
Bumetanide NDC 0904-7016
Bumetanide 1 mg/1 · Tablet · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-7016-04 | 00904701604 | 30 BLISTER PACK in 1 CARTON (0904-7016-04) / 1 TABLET in 1 BLISTER PACKMarketed from Oct 18, 2017 | |
| 0904-7016-06 | 00904701606 | 50 BLISTER PACK in 1 CARTON (0904-7016-06) / 1 TABLET in 1 BLISTER PACKMarketed from Oct 18, 2017 | |
| 0904-7016-61 | 00904701661 | 100 BLISTER PACK in 1 CARTON (0904-7016-61) / 1 TABLET in 1 BLISTER PACKMarketed from Oct 18, 2017 |
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 — 1 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Major Pharmaceuticals
- 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 0904-7016_f2954eff-e0d7-49f4-8f3d-19566b5ce27aSPL ID f2954eff-e0d7-49f4-8f3d-19566b5ce27aSPL set ID a29cf117-00d0-4948-b646-013c8791ea39RxCUI 197418UNII 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 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
N400904701604followed by a unit qualifier and the quantityPackage 00904-7016-04. 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 | Amneal Pharmaceuticals NY LLC | 69238-1490 |
| 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 2 mg/1 | TabletOral | Amneal Pharmaceuticals NY LLC | 69238-1491 |
| Bumetanide | Bumetanide .5 mg/1 | TabletOral | AvPAK | 50268-130 |
| Bumetanide | Bumetanide 1 mg/1 | TabletOral | AvPAK | 50268-131 |
| Bumetanide | Bumetanide 2 mg/1 | TabletOral | AvPAK | 50268-132 |
| Bumetanide | Bumetanide 1 mg/1 | TabletOral | A-S Medication Solutions | 50090-5666 |
| Bumetanide | Bumetanide 2 mg/1 | TabletOral | A-S Medication Solutions | 50090-5663 |
| Bumetanide | Bumetanide .5 mg/1 | TabletOral | A-S Medication Solutions | 50090-5664 |