FDA.reportPublic FDA data

ketorolac tromethamine

Product NDC
71335-3084
11-digit product format
713353084
Labeler code
71335
Product ID
71335-3084_ca3d0ccc-f165-4d06-acf1-13fdaca1802b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ketorolac tromethamine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA217038
Marketing category
ANDA
Marketing start
2022-11-10
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
71335-3084-0ketorolac tromethamine3 in 1 BOTTLETABLET, FILM COATED31
71335-3084-1ketorolac tromethamine30 in 1 BOTTLETABLET, FILM COATED301
71335-3084-2ketorolac tromethamine10 in 1 BOTTLETABLET, FILM COATED101
71335-3084-3ketorolac tromethamine20 in 1 BOTTLETABLET, FILM COATED201
71335-3084-4ketorolac tromethamine90 in 1 BOTTLETABLET, FILM COATED901
71335-3084-5ketorolac tromethamine16 in 1 BOTTLETABLET, FILM COATED161
71335-3084-6ketorolac tromethamine8 in 1 BOTTLETABLET, FILM COATED81
71335-3084-7ketorolac tromethamine15 in 1 BOTTLETABLET, FILM COATED151
71335-3084-8ketorolac tromethamine5 in 1 BOTTLETABLET, FILM COATED51
71335-3084-9ketorolac tromethamine100 in 1 BOTTLETABLET, FILM COATED1001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834022ketorolac tromethamine 10 MG Oral TabletPSN23e7b5f7-ea0d-468d-9d13-a95f9bf605c61
834022ketorolac tromethamine 10 MG Oral TabletSCD23e7b5f7-ea0d-468d-9d13-a95f9bf605c61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-3084-0713353084003 TABLET, FILM COATED in 1 BOTTLE (71335-3084-0) 2026-02-16NoNoHistorical
71335-3084-17133530840130 TABLET, FILM COATED in 1 BOTTLE (71335-3084-1) 2026-02-16NoNoHistorical
71335-3084-27133530840210 TABLET, FILM COATED in 1 BOTTLE (71335-3084-2) 2026-02-16NoNoHistorical
71335-3084-37133530840320 TABLET, FILM COATED in 1 BOTTLE (71335-3084-3) 2026-02-16NoNoHistorical
71335-3084-47133530840490 TABLET, FILM COATED in 1 BOTTLE (71335-3084-4) 2026-02-16NoNoHistorical
71335-3084-57133530840516 TABLET, FILM COATED in 1 BOTTLE (71335-3084-5) 2026-02-16NoNoHistorical
71335-3084-6713353084068 TABLET, FILM COATED in 1 BOTTLE (71335-3084-6) 2026-02-16NoNoHistorical
71335-3084-77133530840715 TABLET, FILM COATED in 1 BOTTLE (71335-3084-7) 2026-02-16NoNoHistorical
71335-3084-8713353084085 TABLET, FILM COATED in 1 BOTTLE (71335-3084-8) 2026-02-16NoNoHistorical
71335-3084-971335308409100 TABLET, FILM COATED in 1 BOTTLE (71335-3084-9) 2026-02-16NoNoHistorical