Bumetanide
- Product NDC
- 16571-679
- 11-digit product format
- 165710679
- Labeler code
- 16571
- Product ID
- 16571-679_ad19edfb-a229-4767-890a-3bf6558ec191
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- bumetanide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc
- Application
- ANDA212019
- Marketing category
- ANDA
- Marketing start
- 2024-06-03
- 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 |
|---|
| 16571-679-01 | Bumetanide | 100 in 1 BOTTLE | TABLET | 100 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16571-679 | BUMETANIDE TABLET [RISING PHARMA HOLDINGS, INC] | 1 | Current NDC, 1 package rows | 20240628_627c9732-eed1-4435-8d79-2e19ab974fd9.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 16571-679-01 | 16571067901 | 100 TABLET in 1 BOTTLE (16571-679-01) | 100 tablet | 2024-06-03 | No | No | Historical |