FDA.reportPublic FDA data

Ketorolac Tromethamine

Product NDC
71335-2658
11-digit product format
713352658
Labeler code
71335
Product ID
71335-2658_270a9819-ffe3-435b-a02e-73878076565d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ketorolac tromethamine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA215788
Marketing category
ANDA
Marketing start
2025-01-18
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
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 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
71335-2658-0Ketorolac Tromethamine3 in 1 BOTTLETABLET, FILM COATED31
71335-2658-1Ketorolac Tromethamine30 in 1 BOTTLETABLET, FILM COATED301
71335-2658-2Ketorolac Tromethamine10 in 1 BOTTLETABLET, FILM COATED101
71335-2658-3Ketorolac Tromethamine20 in 1 BOTTLETABLET, FILM COATED201
71335-2658-4Ketorolac Tromethamine90 in 1 BOTTLETABLET, FILM COATED901
71335-2658-5Ketorolac Tromethamine16 in 1 BOTTLETABLET, FILM COATED161
71335-2658-6Ketorolac Tromethamine8 in 1 BOTTLETABLET, FILM COATED81
71335-2658-7Ketorolac Tromethamine15 in 1 BOTTLETABLET, FILM COATED151
71335-2658-8Ketorolac Tromethamine5 in 1 BOTTLETABLET, FILM COATED51
71335-2658-9Ketorolac Tromethamine100 in 1 BOTTLETABLET, FILM COATED1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2658-0EA - Each71335-265843d16550-343b-4fb8-90b4-362647e96d5312026-05-22
71335-2658-1EA - Each71335-26581b3b0891-5377-4770-b2a4-3ccb20bb0dc812026-05-22
71335-2658-2EA - Each71335-26580cd3c2dd-2119-4856-82a2-81d8ddb0ce7e12026-05-22
71335-2658-3EA - Each71335-265824e6127f-b517-4a62-9050-75fe4eaa6dab12026-05-22
71335-2658-4EA - Each71335-2658a661a08b-6650-4151-82f8-55826a7a338612026-05-22
71335-2658-5EA - Each71335-2658b9854bbe-57e4-4e74-bccd-8b18fc2cd2cb12026-05-22
71335-2658-6EA - Each71335-265886d8ecb0-3809-4d65-888a-87abefee04fd12026-05-22
71335-2658-7EA - Each71335-26588ac73886-673d-47e6-9829-41a2a301cbc512026-05-22
71335-2658-8EA - Each71335-2658aa89c5ed-e9a3-44c1-ba89-1ce3282f274d12026-05-22
71335-2658-9EA - Each71335-2658aab5e719-d994-48b0-aa2d-213f79019fba12026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834022ketorolac tromethamine 10 MG Oral TabletPSNafc691f8-517a-4d88-8322-87dafec8f0641
834022ketorolac tromethamine 10 MG Oral TabletSCDafc691f8-517a-4d88-8322-87dafec8f0641

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2658-0713352658003 TABLET, FILM COATED in 1 BOTTLE (71335-2658-0) 2025-06-23NoNoCurrent
71335-2658-17133526580130 TABLET, FILM COATED in 1 BOTTLE (71335-2658-1) 2025-06-23NoNoCurrent
71335-2658-27133526580210 TABLET, FILM COATED in 1 BOTTLE (71335-2658-2) 2025-06-23NoNoCurrent
71335-2658-37133526580320 TABLET, FILM COATED in 1 BOTTLE (71335-2658-3) 2025-06-23NoNoCurrent
71335-2658-47133526580490 TABLET, FILM COATED in 1 BOTTLE (71335-2658-4) 2025-06-23NoNoCurrent
71335-2658-57133526580516 TABLET, FILM COATED in 1 BOTTLE (71335-2658-5) 2025-06-23NoNoCurrent
71335-2658-6713352658068 TABLET, FILM COATED in 1 BOTTLE (71335-2658-6) 2025-06-23NoNoCurrent
71335-2658-77133526580715 TABLET, FILM COATED in 1 BOTTLE (71335-2658-7) 2025-06-23NoNoCurrent
71335-2658-8713352658085 TABLET, FILM COATED in 1 BOTTLE (71335-2658-8) 2025-06-23NoNoCurrent
71335-2658-971335265809100 TABLET, FILM COATED in 1 BOTTLE (71335-2658-9) 2025-06-23NoNoCurrent