ETHACRYNATE SODIUM
- Product NDC
- 69315-701
- 11-digit product format
- 693150701
- Labeler code
- 69315
- Product ID
- 69315-701_f2c45a04-b3df-48cd-93e2-edb917a029cf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ETHACRYNATE SODIUM
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Leading Pharma, LLC
- Application
- ANDA208663
- Marketing category
- ANDA
- Marketing start
- 2026-01-09
- Substance
- ETHACRYNATE SODIUM
- Active strength
- 50 mg/50mL
- Pharmacologic classes
- Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ETHACRYNATE SODIUM
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ETHACRYNATE SODIUM | 50 mg/50mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | K41MYV7MPM |
| Rxcui | 617325 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69315-701-50 | ETHACRYNATE SODIUM | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 3 |
| 69315-701-50 | ETHACRYNATE SODIUM | 50 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 50 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69315-701 | ETHACRYNATE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [LEADING PHARMA, LLC] | 2 | Current NDC, Legacy NDC, 2 package rows | 20201015_e24e7440-a958-6fd0-6bfe-1bd29e638657.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69315-701-50 | 69315070150 | 1 VIAL, SINGLE-DOSE in 1 CARTON (69315-701-50) / 50 mL in 1 VIAL, SINGLE-DOSE | 2026-01-09 | 0000-00-00 | No | No | Current |