Bumetanide
- Product NDC
- 68083-497
- 11-digit product format
- 680830497
- Labeler code
- 68083
- Product ID
- 68083-497_d9e3877d-de1a-4047-9866-413958c4cca0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bumetanide
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA216434
- Marketing category
- ANDA
- Marketing start
- 2022-05-26
- 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 |
|---|
| 68083-497-01 | Bumetanide | 10 mL in 1 VIAL, MULTI-DOSE | INJECTION | 10 | | 4 |
| 68083-497-10 | Bumetanide | 10 in 1 CARTON | INJECTION | 10 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-497 | BUMETANIDE INJECTION [GLAND PHARMA LIMITED] | 4 | Current NDC, Legacy NDC, 2 package rows | 20220603_4d1ed6b2-c410-4f52-9b8a-aa256c37089e.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 |
|---|
| 68083-497-01 | 68083049701 | 10 mL in 1 VIAL, MULTI-DOSE | 10 ml | | | | | Historical |
| 68083-497-10 | 68083049710 | 10 VIAL, MULTI-DOSE in 1 CARTON (68083-497-10) / 10 mL in 1 VIAL, MULTI-DOSE (68083-497-01) | | 2022-05-26 | 0000-00-00 | No | No | Current |