bumetanide
- Product NDC
- 68382-525
- 11-digit product format
- 683820525
- Labeler code
- 68382
- Product ID
- 68382-525_58b3bb3b-6096-42fd-aebc-c856c3050071
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- bumetanide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals (USA) Inc.
- Application
- ANDA202900
- Marketing category
- ANDA
- Marketing start
- 2018-05-01
- Substance
- BUMETANIDE
- Active strength
- .5 mg/1
- 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 | .5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0Y2S3XUQ5H |
| Rxcui | 197417, 197418, 197419 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68382-525-01 | bumetanide | 100 in 1 BOTTLE | TABLET | 100 | | 5 |
| 68382-525-05 | bumetanide | 500 in 1 BOTTLE | TABLET | 500 | | 5 |
| 68382-525-06 | bumetanide | 30 in 1 BOTTLE | TABLET | 30 | | 5 |
| 68382-525-10 | bumetanide | 1000 in 1 BOTTLE | TABLET | 1000 | | 5 |
| 68382-525-16 | bumetanide | 90 in 1 BOTTLE | TABLET | 90 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68382-525 | BUMETANIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.] | 5 | Current NDC, Legacy NDC, 5 package rows | 20231206_525138cd-832a-41d0-84b0-83921b12bd2a.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 |
|---|
| 68382-525-01 | 68382052501 | 100 TABLET in 1 BOTTLE (68382-525-01) | 100 tablet | 2018-05-01 | 0000-00-00 | No | No | Current |
| 68382-525-05 | 68382052505 | 500 TABLET in 1 BOTTLE (68382-525-05) | 500 tablet | 2018-05-01 | 0000-00-00 | No | No | Current |
| 68382-525-06 | 68382052506 | 30 TABLET in 1 BOTTLE (68382-525-06) | 30 tablet | 2018-05-01 | 0000-00-00 | No | No | Current |
| 68382-525-10 | 68382052510 | 1000 TABLET in 1 BOTTLE (68382-525-10) | 1000 tablet | 2018-05-01 | 0000-00-00 | No | No | Current |
| 68382-525-16 | 68382052516 | 90 TABLET in 1 BOTTLE (68382-525-16) | 90 tablet | 2018-05-01 | 0000-00-00 | No | No | Current |