Home NDC 70436-121 GADOTERIDOL
Product NDC 70436-121
11-digit product format 704360121
Labeler code 70436
Product ID 70436-121_5dc6eef0-0ae7-f7f3-e063-6294a90aa8f6
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 2026-10-15 13:18:30 2026-09 A218749-001 GADOTERIDOL 279.3MG/ML INJECTABLE / INJECTION AP 2025-02-11 c2088c7a36db…2026-09-14 22:38:34 2026-08 A218749-001 GADOTERIDOL 279.3MG/ML INJECTABLE / INJECTION AP 2025-02-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 A218749-001 GADOTERIDOL 279.3MG/ML INJECTABLE / INJECTION AP 2025-02-11 caaa826d4ba7…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# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base GADOTERIDOL
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GADOTERIDOL 279.3 mg/mL
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
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