edetate calcium disodium

Generic: edetate calcium disodium

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name edetate calcium disodium
Generic Name edetate calcium disodium
Labeler rising pharma holdings, inc.
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

edetate calcium disodium 200 mg/mL

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 64980-588
Product ID 64980-588_ccaf3765-ff27-4127-a6be-b4d9437217d8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216435
Listing Expiration 2026-12-31
Marketing Start 2023-05-03

Pharmacologic Class

Classes
anti-coagulant [epc] calcium chelating activity [moa] decreased coagulation factor activity [pe] lead chelating activity [moa] lead chelator [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64980588
Hyphenated Format 64980-588

Supplemental Identifiers

RxCUI
847703
UNII
25IH6R4SGF

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 edetate calcium disodium (source: ndc)
Generic Name edetate calcium disodium (source: ndc)
Application Number ANDA216435 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 200 mg/mL
source: ndc
Packaging
  • 5 VIAL in 1 CARTON (64980-588-51) / 5 mL in 1 VIAL (64980-588-05)
source: ndc

Packages (1)

64980-588-51 5 VIAL in 1 CARTON (64980-588-51) / 5 mL in 1 VIAL (64980-588-05)

Ingredients (1)

edetate calcium disodium (200 mg/mL)

Linked Drug Pages (1)

Edetate Calcium Disodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "ccaf3765-ff27-4127-a6be-b4d9437217d8", "openfda": {"unii": ["25IH6R4SGF"], "rxcui": ["847703"], "spl_set_id": ["710a2c8c-3620-4f6f-b8fc-fb19ab9e9f22"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 VIAL in 1 CARTON (64980-588-51)  / 5 mL in 1 VIAL (64980-588-05)", "package_ndc": "64980-588-51", "marketing_start_date": "20230503"}], "brand_name": "Edetate Calcium Disodium", "product_id": "64980-588_ccaf3765-ff27-4127-a6be-b4d9437217d8", "dosage_form": "INJECTION", "pharm_class": ["Anti-coagulant [EPC]", "Calcium Chelating Activity [MoA]", "Decreased Coagulation Factor Activity [PE]", "Lead Chelating Activity [MoA]", "Lead Chelator [EPC]"], "product_ndc": "64980-588", "generic_name": "Edetate Calcium Disodium", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Edetate Calcium Disodium", "active_ingredients": [{"name": "EDETATE CALCIUM DISODIUM", "strength": "200 mg/mL"}], "application_number": "ANDA216435", "marketing_category": "ANDA", "marketing_start_date": "20230503", "listing_expiration_date": "20261231"}