EDECRIN
- Product NDC
- 25010-215
- 11-digit product format
- 250100215
- Labeler code
- 25010
- Product ID
- 25010-215_4c442b87-1bbd-40e6-8c40-004f5f46e996
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ethacrynic acid
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bausch Health US, LLC
- Application
- NDA016092
- Marketing category
- NDA
- Marketing start
- 1967-01-10
- Substance
- ETHACRYNIC ACID
- Active strength
- 25 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
- EDECRIN
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ETHACRYNIC ACID | 25 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | M5DP350VZV |
| Rxcui | 211509, 617325, 1251903, 1251905 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 93aead9c-5c26-5d19-73e9-d6c55a939061 | Product name | 9 | 20210525 |
| a62a50ac-1535-4461-9768-8ae703e2e9fb | Product name | 1 | 20210525 |
| 01098bd8-4859-4cc2-9426-3489bf88d451 | Product name | 4 | 20201216 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
| bc07ef78-e82d-0c19-31f4-31f263780582 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 25010-215-15 | EDECRIN | 100 in 1 BOTTLE | TABLET | 100 | 10 | |
| 25010-215-65 | EDECRIN | 6 in 1 BOTTLE | TABLET | 6 | 10 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 25010-215-15 | EA - Each | 25010-215 | c24068b7-f24e-4f36-b827-91737605cffa | 1 | 2013-02-13 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| ethacrynic acid | ACTIVE INGREDIENT | M5DP350VZV | EDECRIN (ETHACRYNIC ACID) TABLET [ATON PHARMA, INC.] | 2 | |
| ethacrynic acid | ACTIVE MOIETY | M5DP350VZV | EDECRIN (ETHACRYNIC ACID) TABLET [ATON PHARMA, INC.] | 2 | |
| Lactose | INACTIVE INGREDIENT | J2B2A4N98G | EDECRIN (ETHACRYNIC ACID) TABLET [ATON PHARMA, INC.] | 2 | |
| Magnesium Stearate | INACTIVE INGREDIENT | 70097M6I30 | EDECRIN (ETHACRYNIC ACID) TABLET [ATON PHARMA, INC.] | 2 | |
| Silicon Dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | EDECRIN (ETHACRYNIC ACID) TABLET [ATON PHARMA, INC.] | 2 | |
| Talc | INACTIVE INGREDIENT | 7SEV7J4R1U | EDECRIN (ETHACRYNIC ACID) TABLET [ATON PHARMA, INC.] | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 25010-215 | EDECRIN (ETHACRYNIC ACID) TABLET SODIUM EDECRIN (ETHACRYNATE SODIUM) POWDER, FOR SOLUTION [BAUSCH HEALTH US, LLC] | 10 | Current NDC, Legacy NDC, 2 package rows | 20240806_1efe378e-fee1-4ae9-8ea5-0fe2265fe2d8.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1251905 | Edecrin 25 MG Oral Tablet | PSN | 1efe378e-fee1-4ae9-8ea5-0fe2265fe2d8 | 10 |
| 211509 | Edecrin Sodium 50 MG Injection | PSN | 1efe378e-fee1-4ae9-8ea5-0fe2265fe2d8 | 10 |
| 617325 | ethacrynate sodium 50 MG Injection | PSN | 1efe378e-fee1-4ae9-8ea5-0fe2265fe2d8 | 10 |
| 1251903 | ethacrynic acid 25 MG Oral Tablet | PSN | 1efe378e-fee1-4ae9-8ea5-0fe2265fe2d8 | 10 |
| 211509 | ethacrynate sodium 50 MG Injection [Edecrin] | SBD | 1efe378e-fee1-4ae9-8ea5-0fe2265fe2d8 | 10 |
| 1251905 | ethacrynic acid 25 MG Oral Tablet [Edecrin] | SBD | 1efe378e-fee1-4ae9-8ea5-0fe2265fe2d8 | 10 |
| 617325 | ethacrynate sodium 50 MG Injection | SCD | 1efe378e-fee1-4ae9-8ea5-0fe2265fe2d8 | 10 |
| 1251903 | ethacrynic acid 25 MG Oral Tablet | SCD | 1efe378e-fee1-4ae9-8ea5-0fe2265fe2d8 | 10 |
| 1251905 | Edecrin 25 MG Oral Tablet | SY | 1efe378e-fee1-4ae9-8ea5-0fe2265fe2d8 | 10 |
| 211509 | Edecrin 50 MG Injection | SY | 1efe378e-fee1-4ae9-8ea5-0fe2265fe2d8 | 10 |
| 211509 | Edecrin Sodium 50 MG (equivalent to ethacrynic acid 50 MG) Injection | SY | 1efe378e-fee1-4ae9-8ea5-0fe2265fe2d8 | 10 |
| 617325 | ethacrynate sodium 50 MG (equivalent to ethacrynic acid 50 MG) Injection | SY | 1efe378e-fee1-4ae9-8ea5-0fe2265fe2d8 | 10 |
| 1251905 | Edecrin 25 MG Oral Tablet | PSN | cfc43a98-2dc4-4edc-ad49-d2e368ea1bc2 | 1 |
| 1251903 | ethacrynic acid 25 MG Oral Tablet | PSN | cfc43a98-2dc4-4edc-ad49-d2e368ea1bc2 | 1 |
| 1251905 | ethacrynic acid 25 MG Oral Tablet [Edecrin] | SBD | cfc43a98-2dc4-4edc-ad49-d2e368ea1bc2 | 1 |
| 1251903 | ethacrynic acid 25 MG Oral Tablet | SCD | cfc43a98-2dc4-4edc-ad49-d2e368ea1bc2 | 1 |
| 1251905 | Edecrin 25 MG Oral Tablet | SY | cfc43a98-2dc4-4edc-ad49-d2e368ea1bc2 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 25010-215-15 | 25010021515 | 100 TABLET in 1 BOTTLE (25010-215-15) | 100 tablet | 1967-01-10 | 0000-00-00 | No | No | Current |
| 25010-215-65 | 25010021565 | 6 in 1 BOTTLE | Historical |