Prescription drug · ANDA
Bumetanide NDC 83301-0080
Bumetanide .25 mg/mL · Injection · Intramuscular, Intravenous · Mullan Pharmaceutical Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83301-0080-2 | 8330100800283301008002 | 10 VIAL, SINGLE-DOSE in 1 CARTON (83301-0080-2) / 4 mL in 1 VIAL, SINGLE-DOSE (83301-0080-1)Marketed from Aug 12, 2025 |
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 — .25 mg/mL
- Dosage form
- Injection
- Route
- Intramuscular, Intravenous
- Labeler
- Mullan Pharmaceutical Inc.NDC labeler code 83301
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219116
- Marketing start
- Listing expires
- Other FDA classes
- Increased Diuresis at Loop of Henle (Physiologic effect)
- Identifiers
- Product ID 83301-0080_4c241a3e-649b-4414-e063-6294a90a3a32SPL ID 4c241a3e-649b-4414-e063-6294a90a3a32SPL set ID b7cd724b-817b-4b45-8133-1ebf505867e7RxCUI 282486, 1727569UNII 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 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
N483301008002followed by a unit qualifier and the quantityPackage 83301-0080-02. 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, USP 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.
About NDC 83301-0080
- What is NDC 83301-0080?
- 83301-0080 is the product NDC for Bumetanide, Bumetanide .25 mg/mL injection, listed with the FDA by Mullan Pharmaceutical Inc.. 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?
- Mullan Pharmaceutical Inc., NDC labeler code 83301. 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 219116
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 | Qilu Pharmaceutical Co., Ltd. | 67184-0593 |
| Bumetanide | Bumetanide .25 mg/mL | InjectionIntramuscular, Intravenous | Qilu Pharmaceutical Co., Ltd. | 67184-0594 |
| Bumetanide | Bumetanide .25 mg/mL | InjectionIntramuscular, Intravenous | Mullan Pharmaceutical Inc. | 83301-0081 |