Home NDC 76420-250 Toronova SUIK
Product NDC 76420-250
11-digit product format 764200250
Labeler code 76420
Product ID 76420-250_47d99edc-46e9-f065-e063-6294a90a5c70
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ketorolac Tromethamine
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Asclemed USA, Inc.
Marketing category UNAPPROVED DRUG OTHER
Marketing start 1997-06-05
Substance KETOROLAC TROMETHAMINE
Active strength 30 mg/mL
Pharmacologic classes Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Toronova SUIK
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength KETOROLAC TROMETHAMINE 30 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4EVE5946BQ 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 76420-250-01 Toronova SUIK 1 in 1 CARTON INJECTION, SOLUTION 1 9 76420-250-01 Toronova SUIK 1 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 1 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76420-250 TORONOVA SUIK (KETOROLAC TROMETHAMINE) INJECTION, SOLUTION [ASCLEMED USA, INC.] 8 Current NDC, Legacy NDC, 2 package rows 20240322_e0ed6947-5520-403b-bc0e-1caa95ab3302.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Toronova SUIK KETOROLAC TROMETHAMINE Asclemed USA, Inc. e0ed6947-5520-403b-bc0e-1caa95ab3302 2026-01-07 Boxed warning, Warnings, Adverse reactions Exact identifier ndc (product): 76420-250
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 76420-250-01 76420025001 1 VIAL, SINGLE-DOSE in 1 CARTON (76420-250-01) / 1 mL in 1 VIAL, SINGLE-DOSE 2021-09-23 0000-00-00 No No Current