ethacrynate sodium

Generic: ethacrynate sodium

Labeler: leading pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ethacrynate sodium
Generic Name ethacrynate sodium
Labeler leading pharma, llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

ethacrynate sodium 50 mg/50mL

Manufacturer
Leading Pharma, LLC

Identifiers & Regulatory

Product NDC 69315-701
Product ID 69315-701_f2c45a04-b3df-48cd-93e2-edb917a029cf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208663
Listing Expiration 2027-12-31
Marketing Start 2026-01-09

Pharmacologic Class

Classes
increased diuresis at loop of henle [pe] loop diuretic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69315701
Hyphenated Format 69315-701

Supplemental Identifiers

RxCUI
617325
UPC
0369315701508
UNII
K41MYV7MPM

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name ethacrynate sodium (source: ndc)
Generic Name ethacrynate sodium (source: ndc)
Application Number ANDA208663 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/50mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (69315-701-50) / 50 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

69315-701-50 1 VIAL, SINGLE-DOSE in 1 CARTON (69315-701-50) / 50 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

ethacrynate sodium (50 mg/50mL)

Linked Drug Pages (1)

ETHACRYNATE SODIUM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "f2c45a04-b3df-48cd-93e2-edb917a029cf", "openfda": {"upc": ["0369315701508"], "unii": ["K41MYV7MPM"], "rxcui": ["617325"], "spl_set_id": ["e24e7440-a958-6fd0-6bfe-1bd29e638657"], "manufacturer_name": ["Leading Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (69315-701-50)  / 50 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "69315-701-50", "marketing_start_date": "20260109"}], "brand_name": "ETHACRYNATE SODIUM", "product_id": "69315-701_f2c45a04-b3df-48cd-93e2-edb917a029cf", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Increased Diuresis at Loop of Henle [PE]", "Loop Diuretic [EPC]"], "product_ndc": "69315-701", "generic_name": "ETHACRYNATE SODIUM", "labeler_name": "Leading Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ETHACRYNATE SODIUM", "active_ingredients": [{"name": "ETHACRYNATE SODIUM", "strength": "50 mg/50mL"}], "application_number": "ANDA208663", "marketing_category": "ANDA", "marketing_start_date": "20260109", "listing_expiration_date": "20271231"}