Ketorolac Tromethamine

Product NDC
76420-032
11-digit product format
764200032
Labeler code
76420
Product ID
76420-032_04ab174a-3ae9-2b8e-e063-6394a90a1df5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketorolac Tromethamine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Asclemed USA, Inc.
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
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
76420-032-01Ketorolac Tromethamine100 in 1 BOTTLETABLET, FILM COATED1003
76420-032-02Ketorolac Tromethamine2 in 1 BOTTLETABLET, FILM COATED23
76420-032-04Ketorolac Tromethamine4 in 1 BOTTLETABLET, FILM COATED43
76420-032-07Ketorolac Tromethamine7 in 1 BOTTLETABLET, FILM COATED73
76420-032-10Ketorolac Tromethamine10 in 1 BOTTLETABLET, FILM COATED103
76420-032-15Ketorolac Tromethamine15 in 1 BOTTLETABLET, FILM COATED153
76420-032-20Ketorolac Tromethamine20 in 1 BOTTLETABLET, FILM COATED203
76420-032-30Ketorolac Tromethamine30 in 1 BOTTLETABLET, FILM COATED303
76420-032-60Ketorolac Tromethamine60 in 1 BOTTLETABLET, FILM COATED603
76420-032-90Ketorolac Tromethamine90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-032KETOROLAC TROMETHAMINE TABLET, FILM COATED [ASCLEMED USA, INC.]3Current NDC, Legacy NDC, 10 package rows20230907_94c7c57a-fd1e-41ab-bc39-9a538f6011d1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834022ketorolac tromethamine 10 MG Oral TabletPSN94c7c57a-fd1e-41ab-bc39-9a538f6011d13
834022ketorolac tromethamine 10 MG Oral TabletSCD94c7c57a-fd1e-41ab-bc39-9a538f6011d13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76420-032-0176420003201100 TABLET, FILM COATED in 1 BOTTLE (76420-032-01) 2022-09-160000-00-00NoNoCurrent
76420-032-02764200032022 TABLET, FILM COATED in 1 BOTTLE (76420-032-02) 2020-11-100000-00-00NoNoCurrent
76420-032-04764200032044 TABLET, FILM COATED in 1 BOTTLE (76420-032-04) 2020-11-100000-00-00NoNoCurrent
76420-032-07764200032077 TABLET, FILM COATED in 1 BOTTLE (76420-032-07) 2023-09-06NoNoCurrent
76420-032-107642000321010 TABLET, FILM COATED in 1 BOTTLE (76420-032-10) 2022-09-160000-00-00NoNoCurrent
76420-032-157642000321515 TABLET, FILM COATED in 1 BOTTLE (76420-032-15) 2022-09-16NoNoCurrent
76420-032-207642000322020 TABLET, FILM COATED in 1 BOTTLE (76420-032-20) 2022-09-160000-00-00NoNoCurrent
76420-032-307642000323030 TABLET, FILM COATED in 1 BOTTLE (76420-032-30) 2022-09-160000-00-00NoNoCurrent
76420-032-607642000326060 TABLET, FILM COATED in 1 BOTTLE (76420-032-60) 2022-09-160000-00-00NoNoCurrent
76420-032-907642000329090 TABLET, FILM COATED in 1 BOTTLE (76420-032-90) 2022-09-160000-00-00NoNoCurrent