Home NDC 69945-314 Kit for the Preparation of Technetium Tc 99m Pentetate
Product NDC 69945-314
11-digit product format 699450314
Labeler code 69945
Product ID 69945-314_3153807a-9849-8e8b-e063-6294a90a7c34
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name kit for the preparation of technetium tc 99m pentetate
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS; RESPIRATORY (INHALATION)
Labeler Curium US LLC
Application ANDA215146
Marketing category ANDA
Marketing start 2025-04-08
Substance PENTETIC ACID
Active strength 20 mg/mL
Pharmacologic classes 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 42 .
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 A215146-001 TECHNETIUM TC-99M PENTETATE KIT TECHNETIUM TC-99M PENTETATE KIT N/A INJECTABLE / INJECTION AP 2025-03-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215146-001 AP
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 2026-08-18 06:07:40 2026-07 A215146-001 TECHNETIUM TC-99M PENTETATE KIT N/A INJECTABLE / INJECTION AP 2025-03-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215146-001 TECHNETIUM TC-99M PENTETATE KIT N/A INJECTABLE / INJECTION AP 2025-03-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215146-001 TECHNETIUM TC-99M PENTETATE KIT N/A INJECTABLE / INJECTION AP 2025-03-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215146-001 TECHNETIUM TC-99M PENTETATE KIT N/A INJECTABLE / INJECTION AP 2025-03-26 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215146-001 TECHNETIUM TC-99M PENTETATE KIT N/A INJECTABLE / INJECTION AP 2025-03-26 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Kit for the Preparation of Technetium Tc 99m Pentetate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PENTETIC ACID 20 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7A314HQM0I Internal UNII 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 69945-314-01 Kit for the Preparation of Technetium Tc 99m Pentetate 10 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 10 1 69945-314-05 Kit for the Preparation of Technetium Tc 99m Pentetate 5 in 1 KIT INJECTION, POWDER, LYOPHILIZED, 5 1 69945-314-30 Kit for the Preparation of Technetium Tc 99m Pentetate 30 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69945-314 KIT FOR THE PREPARATION OF TECHNETIUM TC 99M PENTETATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CURIUM US LLC] 1 Current NDC, 3 package rows 20250409_59b3b7d5-ff69-4642-971e-99026d9dce89.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 69945-314-01 69945031401 10 mL in 1 VIAL 10 ml Historical 69945-314-05 69945031405 5 VIAL in 1 KIT (69945-314-05) / 10 mL in 1 VIAL (69945-314-01) 5 vial 2025-04-08 No No Current 69945-314-30 69945031430 30 VIAL in 1 CARTON (69945-314-30) / 10 mL in 1 VIAL (69945-314-01) 30 vial 2025-04-08 No No Current