Ketorolac Tromethamine

Product NDC
71335-2136
11-digit product format
713352136
Labeler code
71335
Product ID
71335-2136_f1d92737-780f-4c36-a655-ca478c850a4b
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
2022-05-23
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
71335-2136-0Ketorolac Tromethamine3 in 1 BOTTLETABLET, FILM COATED3101
71335-2136-1Ketorolac Tromethamine30 in 1 BOTTLETABLET, FILM COATED30101
71335-2136-2Ketorolac Tromethamine10 in 1 BOTTLETABLET, FILM COATED10101
71335-2136-3Ketorolac Tromethamine20 in 1 BOTTLETABLET, FILM COATED20101
71335-2136-4Ketorolac Tromethamine90 in 1 BOTTLETABLET, FILM COATED90101
71335-2136-5Ketorolac Tromethamine16 in 1 BOTTLETABLET, FILM COATED16101
71335-2136-6Ketorolac Tromethamine8 in 1 BOTTLETABLET, FILM COATED8101
71335-2136-7Ketorolac Tromethamine15 in 1 BOTTLETABLET, FILM COATED15101
71335-2136-8Ketorolac Tromethamine5 in 1 BOTTLETABLET, FILM COATED5101
71335-2136-9Ketorolac Tromethamine100 in 1 BOTTLETABLET, FILM COATED100101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2136KETOROLAC TROMETHAMINE TABLET, FILM COATED [BRYANT RANCH PREPACK]101Current NDC, Legacy NDC, 10 package rows20231129_9e5fde54-2206-4072-afb8-4d06a8d314b1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834022ketorolac tromethamine 10 MG Oral TabletPSN9e5fde54-2206-4072-afb8-4d06a8d314b1101
834022ketorolac tromethamine 10 MG Oral TabletSCD9e5fde54-2206-4072-afb8-4d06a8d314b1101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-2136-0713352136003 TABLET, FILM COATED in 1 BOTTLE (71335-2136-0) 2022-08-020000-00-00NoNoCurrent
71335-2136-17133521360130 TABLET, FILM COATED in 1 BOTTLE (71335-2136-1) 2022-08-020000-00-00NoNoCurrent
71335-2136-27133521360210 TABLET, FILM COATED in 1 BOTTLE (71335-2136-2) 2022-08-020000-00-00NoNoCurrent
71335-2136-37133521360320 TABLET, FILM COATED in 1 BOTTLE (71335-2136-3) 2022-08-020000-00-00NoNoCurrent
71335-2136-47133521360490 TABLET, FILM COATED in 1 BOTTLE (71335-2136-4) 2022-08-020000-00-00NoNoCurrent
71335-2136-57133521360516 TABLET, FILM COATED in 1 BOTTLE (71335-2136-5) 2022-08-020000-00-00NoNoCurrent
71335-2136-6713352136068 TABLET, FILM COATED in 1 BOTTLE (71335-2136-6) 2022-08-020000-00-00NoNoCurrent
71335-2136-77133521360715 TABLET, FILM COATED in 1 BOTTLE (71335-2136-7) 2022-08-020000-00-00NoNoCurrent
71335-2136-8713352136085 TABLET, FILM COATED in 1 BOTTLE (71335-2136-8) 2022-08-020000-00-00NoNoCurrent
71335-2136-971335213609100 TABLET, FILM COATED in 1 BOTTLE (71335-2136-9) 2022-08-020000-00-00NoNoCurrent