Ketorolac Tromethamine

Product NDC
70512-844
11-digit product format
705120844
Labeler code
70512
Product ID
70512-844_457271ef-6508-6596-e063-6394a90a039d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketorolac Tromethamine
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
SOLA Pharmaceuticals, LLC
Application
ANDA217789
Marketing category
ANDA
Marketing start
2024-10-22
Substance
KETOROLAC TROMETHAMINE
Active strength
30 mg/mL
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

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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70512-844-25367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70512-844-25557ba5c1ecfa…9c80585c8c6e…

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A217789-001KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2023-05-10
A217789-002KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2023-05-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A217789-001AP
A217789-002AP

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A217789-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2023-05-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217789-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2023-05-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217789-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2023-05-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217789-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2023-05-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A217789-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2023-05-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217789-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2023-05-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217789-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2023-05-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217789-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2023-05-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217789-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2023-05-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217789-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2023-05-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217789-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2023-05-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217789-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2023-05-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217789-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2023-05-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217789-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2023-05-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217789-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2023-05-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217789-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2023-05-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217789-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2023-05-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217789-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2023-05-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217789-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2023-05-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A217789-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2023-05-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217789-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2023-05-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217789-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2023-05-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217789-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2023-05-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217789-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2023-05-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217789-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2023-05-101e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217789-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2023-05-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A217789-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2023-05-108072bd15b7f6…
2024-05-31 18:47 UTC2024-05A217789-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2023-05-108072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A217789-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2023-05-106a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A217789-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2023-05-106a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A217789-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2023-05-101c564ffb4f44…
2024-02-18 07:12 UTC2024-02A217789-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2023-05-101c564ffb4f44…
2023-12-20 04:57 UTC2023-12A217789-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2023-05-10ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A217789-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2023-05-10ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A217789-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2023-05-10a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A217789-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2023-05-10a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A217789-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2023-05-109b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A217789-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2023-05-109b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A217789-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2023-05-10a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A217789-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2023-05-10a67488948f0b…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A217789-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217789-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217789-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217789-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A217789-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217789-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217789-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217789-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217789-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217789-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217789-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217789-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217789-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217789-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217789-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217789-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217789-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217789-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217789-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A217789-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217789-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217789-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217789-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217789-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217789-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217789-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A217789-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A217789-002AP18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A217789-001AP16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A217789-002AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A217789-001AP11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A217789-002AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A217789-001AP1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A217789-002AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A217789-001AP1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A217789-002AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A217789-001AP19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A217789-002AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A217789-001AP1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A217789-002AP1a67488948f0b…

Additional Listing Data#

Finished product
Yes
Brand name base
Ketorolac Tromethamine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
KETOROLAC TROMETHAMINE30 mg/mL

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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
860092Internal RxNorm lookup
1665459Internal RxNorm lookup
1665461Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2301a6a2-b88a-4c0d-bb6c-ad4a8af7da39Available 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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
bb41bc3a-c643-93c9-055f-a8f48f363af3Product name220190219
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
4f6a8082-ae1e-0ff7-4dc0-77f9f0f7b70cProduct name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8d3e992f-8ff7-c106-f7eb-1e2d5eb12025Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70512-844-01Ketorolac Tromethamine2 mL in 1 VIALINJECTION29
70512-844-25Ketorolac Tromethamine25 in 1 CARTONINJECTION259

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70512-844-01ML - Milliliter70512-844b72a133f-7ddf-4449-8bdf-e94131711ea812024-12-10
70512-844-25ML - Milliliter70512-8446222e9d2-4971-4aa1-8cb9-a78d514e1cb512024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70512-844KETOROLAC TROMETHAMINE INJECTION [SOLA PHARMACEUTICALS, LLC]8Current NDC, 2 package rows20241025_2301a6a2-b88a-4c0d-bb6c-ad4a8af7da39.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINEGLENMARK PHARMACEUTICALS INC., USAce992bee-a9f5-48bd-a00e-513f590d69f22026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217789
application number: ANDA217789
KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINEMedical Purchasing Solutions, LLC46434a32-b727-0c5b-e063-6394a90a0c482025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217789
application number: ANDA217789
Ketorolac TromethamineKETOROLAC TROMETHAMINESOLA Pharmaceuticals, LLC2301a6a2-b88a-4c0d-bb6c-ad4a8af7da392025-12-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217789
application number: ANDA217789
ndc (product): 70512-844
KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINEREMEDYREPACK INC.cdd4d548-33f8-42d6-8eae-e36aa577c0502025-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217789
application number: ANDA217789
KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINECaplin Steriles Limited588b4804-4ac5-4b96-947e-354029ea4df92024-10-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217789
application number: ANDA217789
KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINENorthStar Rx LLCbdfb7f14-ad9c-4901-844b-aacfbb4429c32024-04-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217789
application number: ANDA217789

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860092ketorolac tromethamine 15 MG in 1 ML InjectionPSN2301a6a2-b88a-4c0d-bb6c-ad4a8af7da399
1665461ketorolac tromethamine 30 MG in 1 ML InjectionPSN2301a6a2-b88a-4c0d-bb6c-ad4a8af7da399
1665459ketorolac tromethamine 60 MG in 2 ML InjectionPSN2301a6a2-b88a-4c0d-bb6c-ad4a8af7da399
8600921 ML ketorolac tromethamine 15 MG/ML InjectionSCD2301a6a2-b88a-4c0d-bb6c-ad4a8af7da399
16654611 ML ketorolac tromethamine 30 MG/ML InjectionSCD2301a6a2-b88a-4c0d-bb6c-ad4a8af7da399
16654592 ML ketorolac tromethamine 30 MG/ML InjectionSCD2301a6a2-b88a-4c0d-bb6c-ad4a8af7da399
860092ketorolac tromethamine 15 MG per 1 ML InjectionSY2301a6a2-b88a-4c0d-bb6c-ad4a8af7da399
1665461ketorolac tromethamine 30 MG per 1 ML InjectionSY2301a6a2-b88a-4c0d-bb6c-ad4a8af7da399
1665459ketorolac tromethamine 60 MG per 2 ML InjectionSY2301a6a2-b88a-4c0d-bb6c-ad4a8af7da399

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70512-844-01705120844012 mL in 1 VIAL2 mlHistorical
70512-844-257051208442525 VIAL in 1 CARTON (70512-844-25) / 2 mL in 1 VIAL (70512-844-01) 25 vial2024-10-22NoNoCurrent