FDA.reportPublic FDA data

Ketorolac Tromethamine

Product NDC
87234-7695
11-digit product format
872347695
Labeler code
87234
Product ID
87234-7695_52bdfbeb-9ecd-be73-e063-6294a90a3194
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketorolac Tromethamine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Injecta Medcial LLC
Application
ANDA216651
Marketing category
ANDA
Marketing start
2026-05-18
Substance
KETOROLAC TROMETHAMINE
Active strength
10 mg/1
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 TROMETHAMINE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4EVE5946BQ
Rxcui834022

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
87234-7695-1Ketorolac Tromethamine10 in 1 BOTTLETABLET, FILM COATED103
87234-7695-2Ketorolac Tromethamine10 in 1 CARTONTABLET, FILM COATED103
87234-7695-2Ketorolac Tromethamine1 in 1 BLISTER PACKTABLET, FILM COATED13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834022ketorolac tromethamine 10 MG Oral TabletPSN515464a7-16c5-2811-e063-6294a90aa4513
834022ketorolac tromethamine 10 MG Oral TabletPSN521b3d09-df08-fcae-e063-6294a90a65453
834022ketorolac tromethamine 10 MG Oral TabletSCD515464a7-16c5-2811-e063-6294a90aa4513
834022ketorolac tromethamine 10 MG Oral TabletSCD521b3d09-df08-fcae-e063-6294a90a65453

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87234-7695-18723476950110 TABLET, FILM COATED in 1 BOTTLE (87234-7695-1) 2026-05-08NoNoCurrent
87234-7695-28723476950210 BLISTER PACK in 1 CARTON (87234-7695-2) / 1 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2026-05-18NoNoCurrent