FDA.reportPublic FDA data

ketorolac tromethamine

Product NDC
70518-2927
11-digit product format
705182927
Labeler code
70518
Product ID
70518-2927_4ab8d5b7-3c55-255a-e063-6294a90ae2cb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ketorolac tromethamine
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
REMEDYREPACK INC.
Application
ANDA204216
Marketing category
ANDA
Marketing start
2020-10-30
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
ketorolac tromethamine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
KETOROLAC TROMETHAMINE30 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4EVE5946BQ
Rxcui1665461

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6a38bd75-79e3-96c0-1204-08a0282902aeProduct name420250128
4d6e22a5-3693-6edf-0179-2ab93aecbadbProduct name920240724
03452e68-2506-686e-a908-f2381c778fc6Product name520240307
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
bb41bc3a-c643-93c9-055f-a8f48f363af3Product name220190219
4f6a8082-ae1e-0ff7-4dc0-77f9f0f7b70cProduct name120140508
8d3e992f-8ff7-c106-f7eb-1e2d5eb12025Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2927-0ketorolac tromethamine25 in 1 CARTONINJECTION, SOLUTION2513
70518-2927-1ketorolac tromethamine1 mL in 1 VIALINJECTION, SOLUTION113

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2927KETOROLAC TROMETHAMINE INJECTION, SOLUTION [REMEDYREPACK INC.]9Current NDC, Legacy NDC, 2 package rows20250406_43d07956-90ba-4e96-b265-aec03eced19b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665461ketorolac tromethamine 30 MG in 1 ML InjectionPSN43d07956-90ba-4e96-b265-aec03eced19b13
16654611 ML ketorolac tromethamine 30 MG/ML InjectionSCD43d07956-90ba-4e96-b265-aec03eced19b13
1665461ketorolac tromethamine 30 MG per 1 ML InjectionSY43d07956-90ba-4e96-b265-aec03eced19b13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2927-07051829270025 VIAL in 1 CARTON (70518-2927-0) / 1 mL in 1 VIAL (70518-2927-1) 25 vial2020-10-300000-00-00NoNoCurrent
70518-2927-1705182927011 mL in 1 VIAL1 mlHistorical