Home NDC 64980-588 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216435-001 EDETATE CALCIUM DISODIUM EDETATE CALCIUM DISODIUM 200MG/ML INJECTABLE / INJECTION RS 2023-05-03
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A216435-001 EDETATE CALCIUM DISODIUM 200MG/ML INJECTABLE / INJECTION RS 2023-05-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216435-001 EDETATE CALCIUM DISODIUM 200MG/ML INJECTABLE / INJECTION RS 2023-05-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216435-001 EDETATE CALCIUM DISODIUM 200MG/ML INJECTABLE / INJECTION RS 2023-05-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216435-001 EDETATE CALCIUM DISODIUM 200MG/ML INJECTABLE / INJECTION RS 2023-05-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216435-001 EDETATE CALCIUM DISODIUM 200MG/ML INJECTABLE / INJECTION RS 2023-05-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216435-001 EDETATE CALCIUM DISODIUM 200MG/ML INJECTABLE / INJECTION RS 2023-05-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216435-001 EDETATE CALCIUM DISODIUM 200MG/ML INJECTABLE / INJECTION RS 2023-05-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216435-001 EDETATE CALCIUM DISODIUM 200MG/ML INJECTABLE / INJECTION RS 2023-05-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216435-001 EDETATE CALCIUM DISODIUM 200MG/ML INJECTABLE / INJECTION RS 2023-05-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216435-001 EDETATE CALCIUM DISODIUM 200MG/ML INJECTABLE / INJECTION RS 2023-05-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216435-001 EDETATE CALCIUM DISODIUM 200MG/ML INJECTABLE / INJECTION RS 2023-05-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216435-001 EDETATE CALCIUM DISODIUM 200MG/ML INJECTABLE / INJECTION RS 2023-05-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216435-001 EDETATE CALCIUM DISODIUM 200MG/ML INJECTABLE / INJECTION RS 2023-05-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216435-001 EDETATE CALCIUM DISODIUM 200MG/ML INJECTABLE / INJECTION RS 2023-05-03 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216435-001 EDETATE CALCIUM DISODIUM 200MG/ML INJECTABLE / INJECTION RS 2023-05-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216435-001 EDETATE CALCIUM DISODIUM 200MG/ML INJECTABLE / INJECTION RS 2023-05-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216435-001 EDETATE CALCIUM DISODIUM 200MG/ML INJECTABLE / INJECTION RS 2023-05-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216435-001 EDETATE CALCIUM DISODIUM 200MG/ML INJECTABLE / INJECTION RS 2023-05-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216435-001 EDETATE CALCIUM DISODIUM 200MG/ML INJECTABLE / INJECTION RS 2023-05-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A216435-001 EDETATE CALCIUM DISODIUM 200MG/ML INJECTABLE / INJECTION RS 2023-05-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A216435-001 EDETATE CALCIUM DISODIUM 200MG/ML INJECTABLE / INJECTION RS 2023-05-03 3f0d92c62455…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216435-001 EDETATE CALCIUM DISODIUM 200MG/ML INJECTABLE / INJECTION RS 2023-05-03 a50c72e98297…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216435-001 CGT 2024-01-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216435-001 CGT 2024-01-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216435-001 CGT 2024-01-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216435-001 CGT 2024-01-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216435-001 CGT 2024-01-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216435-001 CGT 2024-01-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216435-001 CGT 2024-01-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216435-001 CGT 2024-01-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216435-001 CGT 2024-01-08 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216435-001 CGT 2024-01-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216435-001 CGT 2024-01-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216435-001 CGT 2024-01-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216435-001 CGT 2024-01-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216435-001 CGT 2024-01-08 9b2671bbb829…
Additional Listing Data#
Finished product Yes
Brand name base Edetate Calcium Disodium
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength EDETATE CALCIUM DISODIUM 200 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 25IH6R4SGF Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 847703 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 64980-588-05 Edetate Calcium Disodium 5 mL in 1 VIAL INJECTION 5 3 64980-588-51 Edetate Calcium Disodium 5 in 1 CARTON INJECTION 5 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64980-588 EDETATE CALCIUM DISODIUM INJECTION [RISING PHARMA HOLDINGS, INC.] 3 Current NDC, 2 package rows 20250302_710a2c8c-3620-4f6f-b8fc-fb19ab9e9f22.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 64980-588-05 64980058805 5 mL in 1 VIAL 5 ml Historical 64980-588-51 64980058851 5 VIAL in 1 CARTON (64980-588-51) / 5 mL in 1 VIAL (64980-588-05) 5 vial 2023-05-03 No No Current