FDA.reportPublic FDA data

Ketorolac Tromethamine

Product NDC
85766-035
11-digit product format
857660035
Labeler code
85766
Product ID
85766-035_4eb1e4ce-535e-cbea-e063-6394a90a799d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketorolac Tromethamine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sportpharm LLC
Application
ANDA074754
Marketing category
ANDA
Marketing start
1998-06-17
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
85766-035-01Ketorolac Tromethamine100 in 1 BOTTLETABLET, FILM COATED1003
85766-035-06Ketorolac Tromethamine6 in 1 BOTTLETABLET, FILM COATED63
85766-035-10Ketorolac Tromethamine10 in 1 BOTTLETABLET, FILM COATED103
85766-035-14Ketorolac Tromethamine14 in 1 BOTTLETABLET, FILM COATED143
85766-035-20Ketorolac Tromethamine20 in 1 BOTTLETABLET, FILM COATED203
85766-035-30Ketorolac Tromethamine30 in 1 BOTTLETABLET, FILM COATED303
85766-035-60Ketorolac Tromethamine60 in 1 BOTTLETABLET, FILM COATED603
85766-035-90Ketorolac Tromethamine90 in 1 BOTTLETABLET, FILM COATED903

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834022ketorolac tromethamine 10 MG Oral TabletPSN0749f61d-12e6-4280-8f41-bd4df81e7ae63
834022ketorolac tromethamine 10 MG Oral TabletSCD0749f61d-12e6-4280-8f41-bd4df81e7ae63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
85766-035-0185766003501100 TABLET, FILM COATED in 1 BOTTLE (85766-035-01) 2025-08-07NoNoCurrent
85766-035-06857660035066 TABLET, FILM COATED in 1 BOTTLE (85766-035-06) 2026-04-05NoNoCurrent
85766-035-108576600351010 TABLET, FILM COATED in 1 BOTTLE (85766-035-10) 2025-08-07NoNoCurrent
85766-035-148576600351414 TABLET, FILM COATED in 1 BOTTLE (85766-035-14) 2025-08-07NoNoCurrent
85766-035-208576600352020 TABLET, FILM COATED in 1 BOTTLE (85766-035-20) 2025-08-07NoNoCurrent
85766-035-308576600353030 TABLET, FILM COATED in 1 BOTTLE (85766-035-30) 2025-08-07NoNoCurrent
85766-035-608576600356060 TABLET, FILM COATED in 1 BOTTLE (85766-035-60) 2025-08-07NoNoCurrent
85766-035-908576600359090 TABLET, FILM COATED in 1 BOTTLE (85766-035-90) 2025-08-07NoNoCurrent