Bumetanide
- Product NDC
- 68462-469
- 11-digit product format
- 684620469
- Labeler code
- 68462
- Product ID
- 68462-469_f211e18e-2cd7-4316-8edc-089ed734ccb8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bumetanide
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- GLENMARK PHARMACEUTICALS INC., USA
- Application
- ANDA216434
- Marketing category
- ANDA
- Marketing start
- 2023-01-01
- 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 |
|---|
| 68462-469-40 | Bumetanide | 4 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 4 | | 2 |
| 68462-469-54 | Bumetanide | 10 in 1 CARTON | INJECTION | 10 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68462-469 | BUMETANIDE INJECTION [GLENMARK PHARMACEUTICALS INC., USA] | 1 | Current NDC, Legacy NDC, 2 package rows | 20230107_680563fe-5d3a-49bc-86a5-740bda2acebe.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 |
|---|
| 68462-469-40 | 68462046940 | 4 mL in 1 VIAL, SINGLE-DOSE | 4 ml | | | | | Historical |
| 68462-469-54 | 68462046954 | 10 VIAL, SINGLE-DOSE in 1 CARTON (68462-469-54) / 4 mL in 1 VIAL, SINGLE-DOSE (68462-469-40) | | 2023-01-01 | 0000-00-00 | No | No | Current |