Prescription drug · ANDA
Bumetanide NDC 81469-221
Bumetanide .5 mg/1 · Tablet · Oral · First Nation Group, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 81469-221-01 | 81469022101 | 100 TABLET in 1 BOTTLE (81469-221-01)Marketed from Feb 19, 2026 |
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
- Labeler
- First Nation Group, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219291
- Marketing start
- Listing expires
- Other FDA classes
- Increased Diuresis at Loop of Henle (Physiologic effect)
- Identifiers
- Product ID 81469-221_25bc351d-4705-4d81-9d44-ac191ec15a34SPL ID 25bc351d-4705-4d81-9d44-ac191ec15a34SPL set ID 79b77945-74a7-4cb5-8aa0-33a7babdf6d9RxCUI 197417, 197418, 197419UNII 0Y2S3XUQ5HUPC 0381469221015, 0381469223057, 0381469222012, 0381469223019
- 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
N481469022101followed by a unit qualifier and the quantityPackage 81469-0221-01. 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 219291
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 | First Nation Group, LLC | 81469-223 |
| Bumetanide | Bumetanide 1 mg/1 | TabletOral | First Nation Group, LLC | 81469-222 |
| Bumetanide | Bumetanide 2 mg/1 | TabletOral | Lifestar Pharma LLC | 70756-081 |
| Bumetanide | Bumetanide .5 mg/1 | TabletOral | Lifestar Pharma LLC | 70756-079 |
| Bumetanide | Bumetanide 1 mg/1 | TabletOral | Lifestar Pharma LLC | 70756-080 |
| Bumetanide | Bumetanide 1 mg/1 | TabletOral | A-S Medication Solutions | 50090-7965 |
| Bumetanide | Bumetanide 2 mg/1 | TabletOral | A-S Medication Solutions | 50090-7854 |