Prescription drug · ANDA
Bumetanide NDC 50268-131
Bumetanide 1 mg/1 · Tablet · Oral · AvPAK
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50268-131-15 | 5026801311550268013115 | 50 BLISTER PACK in 1 BOX (50268-131-15) / 1 TABLET in 1 BLISTER PACK (50268-131-11)Marketed from Apr 23, 2019 |
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 — 1 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- AvPAKNDC labeler code 50268
- 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 50268-131_4cc52e19-c90a-933d-e063-6294a90a917cSPL ID 4cc52e19-c90a-933d-e063-6294a90a917cSPL set ID 87385a0a-e7e6-8b7f-e053-2991aa0aa21aRxCUI 197417, 197418, 197419UNII 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
N450268013115followed by a unit qualifier and the quantityPackage 50268-0131-15. 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.
About NDC 50268-131
- What is NDC 50268-131?
- 50268-131 is the product NDC for Bumetanide, Bumetanide 1 mg/1 tablet, listed with the FDA by AvPAK. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Bumetanide.
- What is the active ingredient?
- Bumetanide.
- Who is the labeler?
- AvPAK, NDC labeler code 50268. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Bumetanide?
- 122 other product NDCs are listed under this name. See all Bumetanide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Bumetanide products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Bumetanide | Bumetanide .5 mg/1 | TabletOral | Sandoz Inc | 0781-8099 | 00781-8099-0100781-8099-05 |
| Bumetanide | Bumetanide 1 mg/1 | TabletOral | Sandoz Inc | 0781-8113 | 00781-8113-0100781-8113-05 |
| Bumetanide | Bumetanide 2 mg/1 | TabletOral | Sandoz Inc | 0781-8160 | 00781-8160-01 |
| Bumetanide | Bumetanide .25 mg/mL | Injection, SolutionIntramuscular, Intravenous | Civica, Inc. | 72572-210 | 72572-0210-10 |
| Bumetanide | Bumetanide .25 mg/mL | Injection, SolutionIntramuscular, Intravenous | Civica, Inc. | 72572-211 | 72572-0211-10 |
| Bumetanide | Bumetanide .25 mg/mL | InjectionIntramuscular, Intravenous | Cardinal Health 107, LLC | 55154-5131 | 55154-5131-05 |
| Bumetanide | Bumetanide 1 mg/1 | TabletOral | NorthStar Rx LLC | 72603-900 | 72603-0900-0172603-0900-02 |
| Bumetanide | Bumetanide .5 mg/1 | TabletOral | NorthStar Rx LLC | 72603-889 | 72603-0889-01 |
| Bumetanide | Bumetanide 2 mg/1 | TabletOral | NorthStar Rx LLC | 72603-901 | 72603-0901-0172603-0901-02 |
| Bumetanide | Bumetanide .25 mg/mL | Injection, SolutionIntramuscular, Intravenous | Anthea Pharma Private Limited | 83854-007 | 83854-0007-10 |
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 | Major Pharmaceuticals | 0904-7016 |
| 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 .5 mg/1 | TabletOral | Amneal Pharmaceuticals NY LLC | 69238-1489 |
| Bumetanide | Bumetanide 2 mg/1 | TabletOral | Amneal Pharmaceuticals NY LLC | 69238-1491 |
| 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 |
| Bumetanide | Bumetanide 1 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-4345 |
| Bumetanide | Bumetanide .5 mg/1 | TabletOral | AvPAK | 50268-130 |
| Bumetanide | Bumetanide 2 mg/1 | TabletOral | AvPAK | 50268-132 |