Ketorolac Tromethamine

Product NDC
43063-904
11-digit product format
430630904
Labeler code
43063
Product ID
43063-904_302be0ae-863f-db7d-e063-6294a90a1f9d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketorolac Tromethamine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, 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

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…

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 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
add10ccd-c205-4512-9619-253290fa1152Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43063-904-10Ketorolac Tromethamine10 in 1 BOTTLE, PLASTICTABLET, FILM COATED1024
43063-904-15Ketorolac Tromethamine15 in 1 BOTTLE, PLASTICTABLET, FILM COATED1524
43063-904-20Ketorolac Tromethamine20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2024
43063-904-30Ketorolac Tromethamine30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-904-10EA - Each43063-904f770e6dc-ddd3-47f0-a37e-6739c64b8d0812019-01-24
43063-904-15EA - Each43063-9046e872a5f-0611-457c-946c-f6300cdb04fa12019-01-24
43063-904-20EA - Each43063-904dbef5f8b-db74-4ac8-8d01-98756da9918b12019-02-13
43063-904-30EA - Each43063-90429404dd8-7612-458d-bfd5-084ad140247f12024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-904KETOROLAC TROMETHAMINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]24Current NDC, Legacy NDC, 4 package rows20250315_add10ccd-c205-4512-9619-253290fa1152.zip

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
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
ndc (product): 43063-904
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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834022ketorolac tromethamine 10 MG Oral TabletPSNadd10ccd-c205-4512-9619-253290fa115224
834022ketorolac tromethamine 10 MG Oral TabletSCDadd10ccd-c205-4512-9619-253290fa115224

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-904-104306309041010 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-904-10) 2018-11-080000-00-00NoNoCurrent
43063-904-154306309041515 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-904-15) 2018-12-110000-00-00NoNoCurrent
43063-904-204306309042020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-904-20) 2018-12-170000-00-00NoNoCurrent
43063-904-304306309043030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-904-30) 2024-09-10NoNoCurrent