FDA.reportPublic FDA data

ketorolac tromethamine

Product NDC
47335-935
11-digit product format
473350935
Labeler code
47335
Product ID
47335-935_4d86168f-6d0f-4338-8e59-9ad241a9fadb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ketorolac tromethamine
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA078737
Marketing category
ANDA
Marketing start
2022-12-25
Substance
KETOROLAC TROMETHAMINE
Active strength
60 mg/2mL
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ketorolac tromethamine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
KETOROLAC TROMETHAMINE60 mg/2mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4EVE5946BQ
Rxcui860092, 1665459, 1665461

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
47335-935-40ketorolac tromethamine1 mL in 1 VIAL, SINGLE-DOSEINJECTION19
47335-935-45ketorolac tromethamine25 in 1 CARTONINJECTION259

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47335-935KETOROLAC TROMETHAMINE INJECTION [SUN PHARMACEUTICAL INDUSTRIES, INC.]9Current NDC, Legacy NDC, 2 package rows20240805_29a92a7c-68d1-489b-ba27-d788b3153795.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860092ketorolac tromethamine 15 MG in 1 ML InjectionPSN29a92a7c-68d1-489b-ba27-d788b31537959
1665461ketorolac tromethamine 30 MG in 1 ML InjectionPSN29a92a7c-68d1-489b-ba27-d788b31537959
1665459ketorolac tromethamine 60 MG in 2 ML InjectionPSN29a92a7c-68d1-489b-ba27-d788b31537959
8600921 ML ketorolac tromethamine 15 MG/ML InjectionSCD29a92a7c-68d1-489b-ba27-d788b31537959
16654611 ML ketorolac tromethamine 30 MG/ML InjectionSCD29a92a7c-68d1-489b-ba27-d788b31537959
16654592 ML ketorolac tromethamine 30 MG/ML InjectionSCD29a92a7c-68d1-489b-ba27-d788b31537959
860092ketorolac tromethamine 15 MG per 1 ML InjectionSY29a92a7c-68d1-489b-ba27-d788b31537959
1665461ketorolac tromethamine 30 MG per 1 ML InjectionSY29a92a7c-68d1-489b-ba27-d788b31537959
1665459ketorolac tromethamine 60 MG per 2 ML InjectionSY29a92a7c-68d1-489b-ba27-d788b31537959

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47335-935-40473350935401 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
47335-935-454733509354525 VIAL, SINGLE-DOSE in 1 CARTON (47335-935-45) / 1 mL in 1 VIAL, SINGLE-DOSE (47335-935-40) 2022-12-250000-00-00NoNoCurrent