FDA.reportPublic FDA data

Ketorolac Tromethamine

Product NDC
71335-2444
11-digit product format
713352444
Labeler code
71335
Product ID
71335-2444_3531818e-2753-d40a-e063-6394a90a117b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketorolac Tromethamine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA216759
Marketing category
ANDA
Marketing start
2023-03-10
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
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
71335-2444-0Ketorolac Tromethamine3 in 1 BOTTLETABLET, FILM COATED32
71335-2444-1Ketorolac Tromethamine30 in 1 BOTTLETABLET, FILM COATED302
71335-2444-2Ketorolac Tromethamine10 in 1 BOTTLETABLET, FILM COATED102
71335-2444-3Ketorolac Tromethamine20 in 1 BOTTLETABLET, FILM COATED202
71335-2444-4Ketorolac Tromethamine90 in 1 BOTTLETABLET, FILM COATED902
71335-2444-5Ketorolac Tromethamine16 in 1 BOTTLETABLET, FILM COATED162
71335-2444-6Ketorolac Tromethamine8 in 1 BOTTLETABLET, FILM COATED82
71335-2444-7Ketorolac Tromethamine15 in 1 BOTTLETABLET, FILM COATED152
71335-2444-8Ketorolac Tromethamine5 in 1 BOTTLETABLET, FILM COATED52
71335-2444-9Ketorolac Tromethamine100 in 1 BOTTLETABLET, FILM COATED1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2444-7EA - Each71335-2444d7542472-f907-4d98-84c1-b08eadad51f412024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2444KETOROLAC TROMETHAMINE TABLET, FILM COATED [BRYANT RANCH PREPACK]2Current NDC, 10 package rows20250519_8f36fde8-bc59-4a59-8659-b173cfd15774.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834022ketorolac tromethamine 10 MG Oral TabletPSN8f36fde8-bc59-4a59-8659-b173cfd157742
834022ketorolac tromethamine 10 MG Oral TabletSCD8f36fde8-bc59-4a59-8659-b173cfd157742

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2444-0713352444003 TABLET, FILM COATED in 1 BOTTLE (71335-2444-0) 2024-07-15NoNoHistorical
71335-2444-17133524440130 TABLET, FILM COATED in 1 BOTTLE (71335-2444-1) 2024-07-15NoNoHistorical
71335-2444-27133524440210 TABLET, FILM COATED in 1 BOTTLE (71335-2444-2) 2024-07-15NoNoHistorical
71335-2444-37133524440320 TABLET, FILM COATED in 1 BOTTLE (71335-2444-3) 2024-07-15NoNoHistorical
71335-2444-47133524440490 TABLET, FILM COATED in 1 BOTTLE (71335-2444-4) 2024-07-15NoNoHistorical
71335-2444-57133524440516 TABLET, FILM COATED in 1 BOTTLE (71335-2444-5) 2024-07-15NoNoHistorical
71335-2444-6713352444068 TABLET, FILM COATED in 1 BOTTLE (71335-2444-6) 2024-07-15NoNoHistorical
71335-2444-77133524440715 TABLET, FILM COATED in 1 BOTTLE (71335-2444-7) 2024-07-15NoNoHistorical
71335-2444-8713352444085 TABLET, FILM COATED in 1 BOTTLE (71335-2444-8) 2024-07-15NoNoHistorical
71335-2444-971335244409100 TABLET, FILM COATED in 1 BOTTLE (71335-2444-9) 2024-07-15NoNoHistorical