Bumetanide
- Product NDC
- 31722-368
- 11-digit product format
- 317220368
- Labeler code
- 31722
- Product ID
- 31722-368_32ba5fc2-0f9e-ee77-e063-6294a90af010
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bumetanide
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA218746
- Marketing category
- ANDA
- Marketing start
- 2025-02-27
- 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 |
|---|
| 31722-368-31 | Bumetanide | 4 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 4 | | 1 |
| 31722-368-32 | 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 |
|---|
| 31722-368 | BUMETANIDE (BUMETANIDE) INJECTION [CAMBER PHARMACEUTICALS, INC.] | 1 | Current NDC, 2 package rows | 20250416_084b34ad-36ba-43bd-a43a-1f4b4da26d8f.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 |
|---|
| 31722-368-31 | 31722036831 | 4 mL in 1 VIAL, SINGLE-DOSE | 4 ml | | | | Historical |
| 31722-368-32 | 31722036832 | 10 VIAL, SINGLE-DOSE in 1 CARTON (31722-368-32) / 4 mL in 1 VIAL, SINGLE-DOSE (31722-368-31) | | 2025-02-27 | No | No | Current |