FDA.reportPublic FDA data

KETOROLAC TROMETHAMINE

Product NDC
51662-1669
11-digit product format
516621669
Labeler code
51662
Product ID
51662-1669_3d746288-681b-5232-e063-6394a90afabd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
KETOROLAC TROMETHAMINE
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
ANDA074802
Marketing category
ANDA
Marketing start
2015-10-30
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
Rxcui1665459

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
51662-1669-1KETOROLAC TROMETHAMINE2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION21
51662-1669-2KETOROLAC TROMETHAMINE1 in 1 POUCHINJECTION, SOLUTION11
51662-1669-3KETOROLAC TROMETHAMINE25 in 1 BOXINJECTION, SOLUTION251

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665459ketorolac tromethamine 60 MG in 2 ML InjectionPSN3d746288-681a-5232-e063-6394a90afabd1
16654592 ML ketorolac tromethamine 30 MG/ML InjectionSCD3d746288-681a-5232-e063-6394a90afabd1
1665459ketorolac tromethamine 60 MG per 2 ML InjectionSY3d746288-681a-5232-e063-6394a90afabd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51662-1669-1516621669012 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical
51662-1669-2516621669021 in 1 POUCHHistorical
51662-1669-35166216690325 POUCH in 1 BOX (51662-1669-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1669-2) / 2 mL in 1 VIAL, SINGLE-DOSE (51662-1669-1) 25 pouch2015-10-30NoNoCurrent