Bumetanide
- Product NDC
- 0641-6161
- 11-digit product format
- 006416161
- Labeler code
- 0641
- Product ID
- 0641-6161_3f316caf-5130-468d-958e-255b7d03bf2d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bumetanide
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA079196
- Marketing category
- ANDA
- Marketing start
- 2008-04-30
- Marketing end
- 0000-00-00
- Substance
- BUMETANIDE
- Active strength
- 0 mg/mL
- Pharmacologic classes
- Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 1d3f2f0a-cce7-32fe-77bf-6ee61839e736 | Product name | 9 | 20260113 |
| 601d9750-f415-d9d9-619c-0a87b4d3f237 | Product name | 3 | 20250331 |
| 1d3f2f0a-cce7-32fe-77bf-6ee61839e736 | Product name | 2 | 20171211 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0641-6161-01 | Bumetanide | 4 mL in 1 VIAL | INJECTION | 4 | 7 | |
| 0641-6161-10 | Bumetanide | 10 in 1 CARTON | INJECTION | 10 | 7 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0641-6161-01 | ML - Milliliter | 0641-6161 | c6730303-e645-4574-a12e-0853a020c855 | 1 | 2015-07-20 |
| 0641-6161-10 | ML - Milliliter | 0641-6161 | f6bfa2b3-17db-4b1e-8ba0-b62ebc9a947b | 1 | 2015-07-20 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| BUMETANIDE | ACTIVE INGREDIENT | 0Y2S3XUQ5H | BUMETANIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.] | 1 | |
| BUMETANIDE | ACTIVE MOIETY | 0Y2S3XUQ5H | BUMETANIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.] | 1 | |
| AMMONIUM ACETATE | INACTIVE INGREDIENT | RRE756S6Q2 | BUMETANIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.] | 1 | |
| BENZYL ALCOHOL | INACTIVE INGREDIENT | LKG8494WBH | BUMETANIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.] | 1 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | BUMETANIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.] | 1 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | BUMETANIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.] | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | BUMETANIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | BUMETANIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 282486 | bumetanide 0.25 MG/ML Injectable Solution | PSN | b5a68154-8003-4b80-81e2-e926524fb72c | 7 |
| 1727569 | bumetanide 1 MG in 4 ML Injection | PSN | b5a68154-8003-4b80-81e2-e926524fb72c | 7 |
| 1727569 | 4 ML bumetanide 0.25 MG/ML Injection | SCD | b5a68154-8003-4b80-81e2-e926524fb72c | 7 |
| 282486 | bumetanide 0.25 MG/ML Injectable Solution | SCD | b5a68154-8003-4b80-81e2-e926524fb72c | 7 |
| 1727569 | bumetanide 1 MG per 4 ML Injection | SY | b5a68154-8003-4b80-81e2-e926524fb72c | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0641-6161-01 | 00641616101 | 4 mL in 1 VIAL | 4 ml | Historical | ||||
| 0641-6161-10 | 00641616110 | 10 VIAL in 1 CARTON (0641-6161-10) > 4 mL in 1 VIAL (0641-6161-01) | 10 vial | 2008-04-30 | 0000-00-00 | No | No | Current |