Home NDC 70436-121 GADOTERIDOL
Product NDC 70436-121
11-digit product format 704360121
Labeler code 70436
Product ID 70436-121_3f886711-cb41-3241-e063-6394a90a5bc7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name GADOTERIDOL
Dosage form INJECTION
Route INTRAVENOUS
Labeler Slate Run Pharmaceuticals, LLC
Application ANDA218749
Marketing category ANDA
Marketing start 2025-02-20
Substance GADOTERIDOL
Active strength 279.3 mg/mL
Pharmacologic classes Magnetic Resonance Contrast Activity [MoA], Paramagnetic Contrast Agent [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 A218749-001 GADOTERIDOL GADOTERIDOL 279.3MG/ML INJECTABLE / INJECTION AP 2025-02-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218749-001 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 2026-02-19 14:30 UTC 2026-02 A218749-001 GADOTERIDOL 279.3MG/ML INJECTABLE / INJECTION AP 2025-02-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218749-001 GADOTERIDOL 279.3MG/ML INJECTABLE / INJECTION AP 2025-02-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218749-001 GADOTERIDOL 279.3MG/ML INJECTABLE / INJECTION AP 2025-02-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218749-001 GADOTERIDOL 279.3MG/ML INJECTABLE / INJECTION AP 2025-02-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218749-001 GADOTERIDOL 279.3MG/ML INJECTABLE / INJECTION AP 2025-02-11 b8a1b40f171c…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218749-001 GADOTERIDOL 279.3MG/ML INJECTABLE / INJECTION AP 2025-02-11 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base GADOTERIDOL
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GADOTERIDOL 279.3 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0199MV609F 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 70436-121-31 GADOTERIDOL 5 mL in 1 VIAL, SINGLE-DOSE INJECTION 5 2 70436-121-31 GADOTERIDOL 5 in 1 CARTON INJECTION 5 2 70436-121-33 GADOTERIDOL 10 mL in 1 VIAL, SINGLE-DOSE INJECTION 10 2 70436-121-33 GADOTERIDOL 5 in 1 CARTON INJECTION 5 2 70436-121-34 GADOTERIDOL 15 mL in 1 VIAL, SINGLE-DOSE INJECTION 15 2 70436-121-34 GADOTERIDOL 5 in 1 CARTON INJECTION 5 2 70436-121-35 GADOTERIDOL 5 in 1 CARTON INJECTION 5 2 70436-121-35 GADOTERIDOL 20 mL in 1 VIAL, SINGLE-DOSE INJECTION 20 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70436-121 GADOTERIDOL INJECTION [SLATE RUN PHARMACEUTICALS, LLC] 1 Current NDC, 8 package rows 20250223_538a70e0-061c-40d2-8447-5b7a4e61a55f.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 Marketing start Sample Exclude flag Status 70436-121-31 70436012131 5 VIAL, SINGLE-DOSE in 1 CARTON (70436-121-31) / 5 mL in 1 VIAL, SINGLE-DOSE 2025-02-20 No No Current 70436-121-33 70436012133 5 VIAL, SINGLE-DOSE in 1 CARTON (70436-121-33) / 10 mL in 1 VIAL, SINGLE-DOSE 2025-02-20 No No Current 70436-121-34 70436012134 5 VIAL, SINGLE-DOSE in 1 CARTON (70436-121-34) / 15 mL in 1 VIAL, SINGLE-DOSE 2025-02-20 No No Current 70436-121-35 70436012135 5 VIAL, SINGLE-DOSE in 1 CARTON (70436-121-35) / 20 mL in 1 VIAL, SINGLE-DOSE 2025-02-20 No No Current