Prescription drug · ANDA
Bumetanide NDC 31722-369
Bumetanide .25 mg/mL · Injection · Intramuscular, Intravenous · Camber Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-369-32 | 31722036932 | 10 VIAL, MULTI-DOSE in 1 CARTON (31722-369-32) / 10 mL in 1 VIAL, MULTI-DOSE (31722-369-10)Marketed from Feb 27, 2025 |
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 — .25 mg/mL
- Dosage form
- Injection
- Route
- Intramuscular, Intravenous
- Labeler
- Camber Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218746
- Marketing start
- Listing expires
- Other FDA classes
- Increased Diuresis at Loop of Henle (Physiologic effect)
- Identifiers
- Product ID 31722-369_32ba5fc2-0f9e-ee77-e063-6294a90af010SPL ID 32ba5fc2-0f9e-ee77-e063-6294a90af010SPL set ID 084b34ad-36ba-43bd-a43a-1f4b4da26d8fRxCUI 282486, 1727569UNII 0Y2S3XUQ5HUPC 0331722369107
- 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N431722036932followed by a unit qualifier and the quantityPackage 31722-0369-32. 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 Injection is 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 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 218746
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 .25 mg/mL | InjectionIntramuscular, Intravenous | Camber Pharmaceuticals, Inc. | 31722-368 |