FDA.reportPublic FDA data

Edetate Calcium Disodium

Product NDC
64980-588
11-digit product format
649800588
Labeler code
64980
Product ID
64980-588_ccaf3765-ff27-4127-a6be-b4d9437217d8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Edetate Calcium Disodium
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA216435
Marketing category
ANDA
Marketing start
2023-05-03
Substance
EDETATE CALCIUM DISODIUM
Active strength
200 mg/mL
Pharmacologic classes
Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Decreased Coagulation Factor Activity [PE], Lead Chelating Activity [MoA], Lead Chelator [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Edetate Calcium Disodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EDETATE CALCIUM DISODIUM200 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii25IH6R4SGF
Rxcui847703

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64980-588-05Edetate Calcium Disodium5 mL in 1 VIALINJECTION53
64980-588-51Edetate Calcium Disodium5 in 1 CARTONINJECTION53

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64980-588-05ML - Milliliter64980-588afe10b42-7f88-4da9-9110-d17dc77522e812023-07-06
64980-588-51ML - Milliliter64980-588a8eb5f13-6e21-4011-8666-9ec769c90d7c12023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64980-588EDETATE CALCIUM DISODIUM INJECTION [RISING PHARMA HOLDINGS, INC.]3Current NDC, 2 package rows20250302_710a2c8c-3620-4f6f-b8fc-fb19ab9e9f22.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
847703edetate calcium disodium 1000 MG in 5 ML InjectionPSN710a2c8c-3620-4f6f-b8fc-fb19ab9e9f223
8477035 ML edetate calcium disodium 200 MG/ML InjectionSCD710a2c8c-3620-4f6f-b8fc-fb19ab9e9f223
847703edetate calcium disodium 1000 MG per 5 ML InjectionSY710a2c8c-3620-4f6f-b8fc-fb19ab9e9f223

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
64980-588-05649800588055 mL in 1 VIAL5 mlHistorical
64980-588-51649800588515 VIAL in 1 CARTON (64980-588-51) / 5 mL in 1 VIAL (64980-588-05) 5 vial2023-05-03NoNoCurrent