Bumetanide
- Product NDC
- 65219-570
- 11-digit product format
- 652190570
- Labeler code
- 65219
- Product ID
- 65219-570_aaff61c4-203b-4905-9138-0f98959ad013
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bumetanide
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA216434
- Marketing category
- ANDA
- Marketing start
- 2022-09-26
- Substance
- BUMETANIDE
- Active strength
- .25 mg/mL
- Pharmacologic classes
- Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Bumetanide
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BUMETANIDE | .25 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0Y2S3XUQ5H |
| Rxcui | 282486, 1727569 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65219-570-01 | Bumetanide | 4 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 4 | | 1 |
| 65219-570-04 | Bumetanide | 10 in 1 CARTON | INJECTION | 10 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65219-570 | BUMETANIDE INJECTION [FRESENIUS KABI USA, LLC] | 1 | Current NDC, Legacy NDC, 2 package rows | 20220927_a007f3aa-3977-4be3-a9a2-db3d458bca58.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65219-570-01 | 65219057001 | 4 mL in 1 VIAL, SINGLE-DOSE | 4 ml | | | | | Historical |
| 65219-570-04 | 65219057004 | 10 VIAL, SINGLE-DOSE in 1 CARTON (65219-570-04) / 4 mL in 1 VIAL, SINGLE-DOSE (65219-570-01) | | 2022-09-26 | 0000-00-00 | No | No | Current |