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United States · US · US:64980-588_ccaf3765-ff27-4127-a6be-b4d9437217d8
Edetate Calcium Disodium
Orange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerRising Pharma Holdings, Inc.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1164980588515 VIAL in 1 CARTON (64980-588-51) / 5 mL in 1 VIAL (64980-588-05)
Annotations
UNII (FDA Substance ID)
25IH6R4SGF
EDETATE CALCIUM DISODIUM
RxCUI 1903
Orange Book
A216435
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "25IH6R4SGF",
"rxcui": "1903",
"inchikey": "JCQNARRMQCMKAN-UHFFFAOYSA-J",
"display_name": "EDETATE CALCIUM DISODIUM",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAMUSCULAR; INTRAVENOUS",
"spl_meta": {
"710a2c8c-3620-4f6f-b8fc-fb19ab9e9f22": {
"match": "brand_token",
"title": "EDETATE CALCIUM DISODIUM INJECTION [RISING PHARMA HOLDINGS, INC.]",
"spl_version": "3",
"published_date": "2025-03-03"
}
},
"productid": "64980-588_ccaf3765-ff27-4127-a6be-b4d9437217d8",
"productndc": "64980-588",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "216435",
"products": [
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "200MG/ML",
"product_no": "001",
"approval_date": "May 3, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "EDETATE CALCIUM DISODIUM",
"proprietary_name": "Edetate Calcium Disodium",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA216435",
"marketing_category": "ANDA",
"nonproprietary_name": "Edetate Calcium Disodium",
"start_marketing_date": "20230503",
"active_numerator_strength": "200"
}Access this data programmatically
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