FDA.reportPublic FDA data

Ketorolac Tromethamine

Product NDC
53002-6990
Requested package NDC
53002-6990-2
11-digit product format
530026990
Labeler code
53002
Product ID
53002-6990_d0fb4bef-06a1-482a-991a-5668530fadd7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketorolac Tromethamine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA074754
Marketing category
ANDA
Marketing start
1998-06-17
Marketing end
0000-00-00
Substance
KETOROLAC TROMETHAMINE
Active strength
10 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage53002-699053002-6990-2IInactivated by FDA2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074754-001KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A074754-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-16a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A074754-001AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ketorolac TromethamineKETOROLAC TROMETHAMINEREMEDYREPACK INC.f47d4365-40a8-445b-99cd-49edad6a8ffc2026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074754
application number: ANDA074754
Ketorolac TromethamineKETOROLAC TROMETHAMINESportpharm LLC0749f61d-12e6-4280-8f41-bd4df81e7ae62026-04-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074754
application number: ANDA074754
Ketorolac TromethamineKETOROLAC TROMETHAMINENorthwind Health Company, LLCd17ed469-677b-4a2e-96a9-5cfd0f50ecd92026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074754
application number: ANDA074754
Ketorolac TromethamineKETOROLAC TROMETHAMINEAmerican Health Packaging48244614-53ec-47e6-ad48-50814bdcceb72025-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074754
application number: ANDA074754
Ketorolac TromethamineKETOROLAC TROMETHAMINEPD-Rx Pharmaceuticals, Inc.add10ccd-c205-4512-9619-253290fa11522025-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074754
application number: ANDA074754
Ketorolac TromethamineKETOROLAC TROMETHAMINEA-S Medication Solutions9fdba2e6-969f-4624-b08b-a42f99e4eff92025-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074754
application number: ANDA074754
Ketorolac TromethamineKETOROLAC TROMETHAMINEAdvanced Rx Pharmacy of Tennessee, LLCc1717245-cef3-b3d7-e053-2a95a90a1ac52024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074754
application number: ANDA074754
Ketorolac TromethamineKETOROLAC TROMETHAMINETeva Pharmaceuticals USA, Inc.688f5dec-a6db-43c6-a1f8-5df99d08d3952024-12-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074754
application number: ANDA074754
Ketorolac TromethamineKETOROLAC TROMETHAMINENuCare Pharmaceuticals, Inc.415a5393-296f-30e3-e054-00144ff8d46c2024-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074754
application number: ANDA074754
Ketorolac TromethamineKETOROLAC TROMETHAMINENuCare Pharmaceuticals, Inc.46dc8f62-e754-50e3-e054-00144ff8d46c2024-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074754
application number: ANDA074754
Ketorolac TromethamineKETOROLAC TROMETHAMINEBryant Ranch Prepackf713500a-20b8-8e20-c4cc-9568051703352023-11-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074754
application number: ANDA074754
Ketorolac TromethamineKETOROLAC TROMETHAMINEAsclemed USA, Inc.94c7c57a-fd1e-41ab-bc39-9a538f6011d12023-09-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074754
application number: ANDA074754
Ketorolac TromethamineKETOROLAC TROMETHAMINEProficient Rx LPf5170993-81a9-4eb7-95ac-60697a5ee1d72022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074754
application number: ANDA074754

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53002-6990-12025-01-30C16284748780-19d75b9d1-143d-f424-e053-dadaa90a57ceKetorolac Tromethamine Tablets USP, 10 mg Rx only
53002-6990-22025-01-30C16284748780-19d75b9d1-143d-f424-e053-dadaa90a57ceKetorolac Tromethamine Tablets USP, 10 mg Rx only
53002-6990-32025-01-30C16284748780-19d75b9d1-143d-f424-e053-dadaa90a57ceKetorolac Tromethamine Tablets USP, 10 mg Rx only
53002-6990-12023-06-07C16284748780-19d75b9d1-143d-f424-e053-dadaa90a57ceKetorolac Tromethamine Tablets USP, 10 mg Rx only
53002-6990-22023-06-07C16284748780-19d75b9d1-143d-f424-e053-dadaa90a57ceKetorolac Tromethamine Tablets USP, 10 mg Rx only
53002-6990-32023-06-07C16284748780-19d75b9d1-143d-f424-e053-dadaa90a57ceKetorolac Tromethamine Tablets USP, 10 mg Rx only
53002-6990-12023-01-30C16284748780-19d75b9d1-143d-f424-e053-dadaa90a57ceKetorolac Tromethamine Tablets USP, 10 mg Rx only
53002-6990-22023-01-30C16284748780-19d75b9d1-143d-f424-e053-dadaa90a57ceKetorolac Tromethamine Tablets USP, 10 mg Rx only
53002-6990-32023-01-30C16284748780-19d75b9d1-143d-f424-e053-dadaa90a57ceKetorolac Tromethamine Tablets USP, 10 mg Rx only
53002-6990-12020-12-17C16284748780-19d75b9d1-143d-f424-e053-dadaa90a57ceKetorolac Tromethamine Tablets USP, 10 mg Rx only
53002-6990-22020-12-17C16284748780-19d75b9d1-143d-f424-e053-dadaa90a57ceKetorolac Tromethamine Tablets USP, 10 mg Rx only
53002-6990-32020-12-17C16284748780-19d75b9d1-143d-f424-e053-dadaa90a57ceKetorolac Tromethamine Tablets USP, 10 mg Rx only
53002-6990-12020-01-31C16284748780-19d75b9d1-143d-f424-e053-dadaa90a57ceKetorolac Tromethamine Tablets USP, 10 mg Rx only
53002-6990-22020-01-31C16284748780-19d75b9d1-143d-f424-e053-dadaa90a57ceKetorolac Tromethamine Tablets USP, 10 mg Rx only
53002-6990-32020-01-31C16284748780-19d75b9d1-143d-f424-e053-dadaa90a57ceKetorolac Tromethamine Tablets USP, 10 mg Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-6990-1Ketorolac Tromethamine10 in 1 BOTTLETABLET, FILM COATED105
53002-6990-2Ketorolac Tromethamine15 in 1 BOTTLETABLET, FILM COATED155
53002-6990-3Ketorolac Tromethamine20 in 1 BOTTLETABLET, FILM COATED205

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-6990KETOROLAC TROMETHAMINE TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.]5Legacy NDC, 3 package rows20230609_a5220202-6eee-4a42-8d4a-8f7475dd1383.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834022ketorolac tromethamine 10 MG Oral TabletPSNa5220202-6eee-4a42-8d4a-8f7475dd13835
834022ketorolac tromethamine 10 MG Oral TabletSCDa5220202-6eee-4a42-8d4a-8f7475dd13835

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53002-6990-25300269900215 TABLET, FILM COATED in 1 BOTTLE (53002-6990-2) 2018-10-010000-00-00NoNoCurrent