Ketorolac Tromethamine

Product NDC
51655-170
Requested package NDC
51655-170-20
11-digit product format
516550170
Labeler code
51655
Product ID
51655-170_4af43a96-9b8b-f47b-e063-6394a90a145b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketorolac Tromethamine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA074754
Marketing category
ANDA
Marketing start
2014-07-15
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
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage51655-17051655-170-20IInactivated by FDAexcluded / ndc_excluded.zipe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage51655-17051655-170-20IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…

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#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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
ndc (package): 51655-170-20
ndc (product): 51655-170
ndc11 (package): 51655017020
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

Additional Listing Data#

Finished product
Yes
Brand name base
Ketorolac Tromethamine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
KETOROLAC TROMETHAMINE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4EVE5946BQInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
834022Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d17ed469-677b-4a2e-96a9-5cfd0f50ecd9Available on FDA.report

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
51655-170-20Ketorolac Tromethamine20 in 1 BOTTLE, DISPENSINGTABLET, FILM COATED204
51655-170-54Ketorolac Tromethamine15 in 1 BOTTLE, DISPENSINGTABLET, FILM COATED154

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
KETOROLAC TROMETHAMINEACTIVE INGREDIENT4EVE5946BQKETOROLAC TROMETHAMINE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]1
KETOROLACACTIVE MOIETYYZI5105V0LKETOROLAC TROMETHAMINE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-170KETOROLAC TROMETHAMINE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]3Current NDC, Legacy NDC, 2 package rows20231115_d17ed469-677b-4a2e-96a9-5cfd0f50ecd9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834022ketorolac tromethamine 10 MG Oral TabletPSNd17ed469-677b-4a2e-96a9-5cfd0f50ecd94
834022ketorolac tromethamine 10 MG Oral TabletSCDd17ed469-677b-4a2e-96a9-5cfd0f50ecd94

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51655-170-205165501702020 TABLET, FILM COATED in 1 BOTTLE, DISPENSING (51655-170-20) 2014-07-150000-00-00NoNoCurrent