ETHACRYNATE SODIUM
- Product NDC
- 42023-157
- 11-digit product format
- 420230157
- Labeler code
- 42023
- Product ID
- 42023-157_923d3573-ccd0-4c71-82e3-6167a23b9161
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ethacrynate sodium
- Dosage form
- INJECTION, POWDER, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Par Health USA, LLC
- Application
- ANDA205473
- Marketing category
- ANDA
- Marketing start
- 2015-07-30
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ETHACRYNATE SODIUM
- Listing expiration
- 2026-12-31
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 |
|---|
| 42023-157-01 | ETHACRYNATE SODIUM | 50 mL in 1 VIAL | INJECTION, POWDER, FOR SOLUTION | 50 | | 6 |
| 42023-157-01 | ETHACRYNATE SODIUM | 1 in 1 CARTON | INJECTION, POWDER, FOR SOLUTION | 1 | | 6 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ethacrynate sodium | ACTIVE INGREDIENT | K41MYV7MPM | ETHACRYNATE SODIUM INJECTION, POWDER, FOR SOLUTION [PAR PHARMACEUTICAL, INC.] | 1 | |
| ethacrynic acid | ACTIVE MOIETY | M5DP350VZV | ETHACRYNATE SODIUM INJECTION, POWDER, FOR SOLUTION [PAR PHARMACEUTICAL, INC.] | 1 | |
| mannitol | INACTIVE INGREDIENT | 3OWL53L36A | ETHACRYNATE SODIUM INJECTION, POWDER, FOR SOLUTION [PAR PHARMACEUTICAL, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42023-157 | ETHACRYNATE SODIUM INJECTION, POWDER, FOR SOLUTION [ENDO USA, INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20241114_3313ed5d-7991-408f-872b-d5a701aa6d83.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 |
|---|
| 42023-157-01 | 42023015701 | 1 VIAL in 1 CARTON (42023-157-01) / 50 mL in 1 VIAL | 1 vial | 2015-07-30 | 0000-00-00 | No | No | Current |
| 42023-157-89 | 42023015789 | 1 VIAL in 1 CARTON (42023-157-89) > 50 mL in 1 VIAL | 1 vial | 2016-05-19 | 0000-00-00 | No | No | Current |
| 42023-157-99 | 42023015799 | 1 VIAL in 1 CARTON (42023-157-99) > 50 mL in 1 VIAL | 1 vial | 2016-09-23 | 0000-00-00 | No | No | Current |