FDA.reportPublic FDA data

Ketorolac Tromethamine

Product NDC
50090-6807
11-digit product format
500906807
Labeler code
50090
Product ID
50090-6807_17061d2b-0252-48ad-8d4a-126d74148e45
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketorolac Tromethamine
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
A-S Medication Solutions
Application
ANDA214456
Marketing category
ANDA
Marketing start
2022-11-02
Substance
KETOROLAC TROMETHAMINE
Active strength
15 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
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 TROMETHAMINE15 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4EVE5946BQ
Rxcui860092

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
50090-6807-0Ketorolac Tromethamine1 mL in 1 VIALINJECTION11
50090-6807-0Ketorolac Tromethamine25 in 1 CARTONINJECTION251

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6807-0ML - Milliliter50090-680707541238-7143-455e-be49-951c058173ff12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6807KETOROLAC TROMETHAMINE INJECTION [A-S MEDICATION SOLUTIONS]1Current NDC, 2 package rows20231115_e0065781-ea33-4662-a8b1-c936e937ac9f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860092ketorolac tromethamine 15 MG in 1 ML InjectionPSNe0065781-ea33-4662-a8b1-c936e937ac9f1
8600921 ML ketorolac tromethamine 15 MG/ML InjectionSCDe0065781-ea33-4662-a8b1-c936e937ac9f1
860092ketorolac tromethamine 15 MG per 1 ML InjectionSYe0065781-ea33-4662-a8b1-c936e937ac9f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6807-05009068070025 VIAL in 1 CARTON (50090-6807-0) / 1 mL in 1 VIAL25 vial2023-11-07NoNoCurrent