FDA.reportPublic FDA data

Ketorolac Tromethamine

Product NDC
43598-139
11-digit product format
435980139
Labeler code
43598
Product ID
43598-139_3afdebc5-20aa-48f5-9a14-bf672ab422cd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ketorolac tromethamine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DR. REDDY'S LABORATORIES, INC.
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
43598-139-01Ketorolac Tromethamine100 in 1 BOTTLETABLET, FILM COATED1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-139-01EA - Each43598-13923ab351d-c078-44dd-9049-6a4418777a0412022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-139KETOROLAC TROMETHAMINE TABLET, FILM COATED [DR. REDDY'S LABORATORIES, INC.]2Current NDC, Legacy NDC, 1 package rows20250114_10827042-a2d4-44f9-837d-2023a3d552ff.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
834022ketorolac tromethamine 10 MG Oral TabletPSN08674066-7d4b-936d-e063-6394a90abbd73
834022ketorolac tromethamine 10 MG Oral TabletPSN48245718-a2df-4938-8d06-3b8abf34181e3
834022ketorolac tromethamine 10 MG Oral TabletPSNf4c2f3b3-06d7-0c3f-e053-2a95a90ae06d3
834022ketorolac tromethamine 10 MG Oral TabletPSNf4e7f1c8-e458-0860-e053-2a95a90a1bf03
834022ketorolac tromethamine 10 MG Oral TabletSCD08674066-7d4b-936d-e063-6394a90abbd73
834022ketorolac tromethamine 10 MG Oral TabletSCD48245718-a2df-4938-8d06-3b8abf34181e3
834022ketorolac tromethamine 10 MG Oral TabletSCDf4c2f3b3-06d7-0c3f-e053-2a95a90ae06d3
834022ketorolac tromethamine 10 MG Oral TabletSCDf4e7f1c8-e458-0860-e053-2a95a90a1bf03
834022ketorolac tromethamine 10 MG Oral TabletPSN10827042-a2d4-44f9-837d-2023a3d552ff2
834022ketorolac tromethamine 10 MG Oral TabletPSNec6d453b-4b84-53d4-e053-2995a90a60062
834022ketorolac tromethamine 10 MG Oral TabletSCD10827042-a2d4-44f9-837d-2023a3d552ff2
834022ketorolac tromethamine 10 MG Oral TabletSCDec6d453b-4b84-53d4-e053-2995a90a60062
834022ketorolac tromethamine 10 MG Oral TabletPSN6fa20b41-f860-4fea-b1fb-ab6d3fa34a901
834022ketorolac tromethamine 10 MG Oral TabletSCD6fa20b41-f860-4fea-b1fb-ab6d3fa34a901

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43598-139-0143598013901100 TABLET, FILM COATED in 1 BOTTLE (43598-139-01) 2022-05-240000-00-00NoNoCurrent