Ketorolac Tromethamine

Product NDC
70934-029
11-digit product format
709340029
Labeler code
70934
Product ID
70934-029_b7b0806f-995d-1d60-e053-2a95a90a9b59
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketorolac Tromethamine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA074754
Marketing category
ANDA
Marketing start
2017-03-17
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70934-029IInactivated by FDA2026-08-03
excluded packagepackage70934-02970934-029-15IInactivated by FDA2026-08-03
excluded packagepackage70934-02970934-029-20IInactivated by FDA2026-08-03
excluded packagepackage70934-02970934-029-30IInactivated 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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALAB1997-05-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-1687673890dc5c…
2021-03-12 10:30 UTC2021-03A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALAB1997-05-163f01610625f2…
2019-09-15 20:21 UTC2019-09A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALAB1997-05-16b00525d2431f…
2019-07-19 19:46 UTC2019-07A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALAB1997-05-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-16e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074754-001KETOROLAC TROMETHAMINE10MGTABLET / ORALABRS1997-05-16cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A074754-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074754-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074754-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074754-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074754-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074754-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074754-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074754-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074754-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074754-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074754-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074754-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074754-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074754-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074754-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074754-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074754-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074754-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074754-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074754-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074754-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A074754-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074754-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074754-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074754-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A074754-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A074754-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074754-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074754-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074754-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074754-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074754-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074754-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074754-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A074754-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A074754-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074754-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074754-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074754-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074754-001AB1cb3db0bc1861…

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70934-029-15Ketorolac Tromethamine15 in 1 BOTTLETABLET, FILM COATED156
70934-029-20Ketorolac Tromethamine20 in 1 BOTTLE, PLASTICTABLET, FILM COATED206
70934-029-30Ketorolac Tromethamine30 in 1 BOTTLE, PLASTICTABLET, FILM COATED306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70934-029-15EA - Each70934-02990248741-173f-4a13-977a-469c5c5d5d7212018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70934-029KETOROLAC TROMETHAMINE TABLET, FILM COATED [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]6Legacy NDC, 3 package rows20201231_4af70eae-71ca-65f2-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834022ketorolac tromethamine 10 MG Oral TabletPSN4af70eae-71ca-65f2-e054-00144ff88e886
834022ketorolac tromethamine 10 MG Oral TabletSCD4af70eae-71ca-65f2-e054-00144ff88e886

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70934-029-157093400291515 TABLET, FILM COATED in 1 BOTTLE (70934-029-15) 2017-03-170000-00-00NoNoCurrent
70934-029-207093400292020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-029-20) 2018-11-190000-00-00NoNoCurrent
70934-029-307093400293030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-029-30) 2018-10-290000-00-00NoNoCurrent