KETOROLAC TROMETHAMINE

Product NDC
64679-758
Requested package NDC
64679-758-02
11-digit product format
646790758
Labeler code
64679
Product ID
64679-758_4da5de82-338e-4a91-9b1d-6ee07b04000b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
KETOROLAC TROMETHAMINE
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Wockhardt USA LLC.
Application
ANDA077942
Marketing category
ANDA
Marketing start
2007-03-27
Marketing end
0000-00-00
Substance
KETOROLAC TROMETHAMINE
Active strength
30 mg/mL
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
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage64679-75864679-758-02DDiscontinued by firm2026-10-05

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A077942-001KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2007-03-27
A077942-002KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2007-03-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077942-001AP
A077942-002AP

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 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A077942-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2007-03-2784e616aacf4f…
2026-09-14 22:38:342026-08A077942-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2007-03-2784e616aacf4f…
2026-08-18 06:07:402026-07A077942-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2007-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A077942-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2007-03-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077942-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2007-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077942-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2007-03-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077942-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2007-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077942-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2007-03-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A077942-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2007-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077942-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2007-03-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077942-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2007-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077942-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2007-03-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077942-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2007-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077942-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2007-03-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077942-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2007-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077942-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2007-03-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077942-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2007-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077942-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2007-03-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077942-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2007-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077942-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2007-03-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077942-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2007-03-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077942-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2007-03-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077942-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2007-03-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A077942-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2007-03-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077942-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2007-03-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077942-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2007-03-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077942-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2007-03-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077942-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2007-03-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077942-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2007-03-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077942-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2007-03-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077942-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2007-03-278072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077942-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2007-03-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077942-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2007-03-275c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077942-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2007-03-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077942-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2007-03-275d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077942-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2007-03-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077942-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2007-03-274b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077942-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2007-03-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077942-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2007-03-2774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077942-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2007-03-2774a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A077942-001AP184e616aacf4f…
2026-09-14 22:38:342026-08A077942-002AP184e616aacf4f…
2026-08-18 06:07:402026-07A077942-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A077942-002AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077942-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077942-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077942-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077942-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077942-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077942-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077942-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077942-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077942-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077942-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077942-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077942-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077942-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077942-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077942-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077942-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077942-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077942-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077942-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077942-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077942-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077942-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077942-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077942-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077942-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077942-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077942-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077942-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077942-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077942-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077942-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077942-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077942-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077942-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077942-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077942-002AP174a2ff9319b5…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64679-758-01ML - Milliliter64679-758b7b9d4a6-5b92-4128-8fa4-5e97510ecd5f12012-07-24
64679-758-02ML - Milliliter64679-758a63eba44-736c-4f05-bc5f-cad77646df2312012-07-24
64679-758-04ML - Milliliter64679-7580da6720d-cf6e-45b8-8f47-db11ea207ea712012-07-24
64679-758-06ML - Milliliter64679-758e17fad4a-ccdf-43ef-bc33-ddf03c1b3ca212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
KETOROLAC TROMETHAMINEACTIVE INGREDIENT4EVE5946BQKETOROLAC TROMETHAMINE INJECTION [PHYSICIANS TOTAL CARE, INC.]2
KETOROLACACTIVE MOIETYYZI5105V0LKETOROLAC TROMETHAMINE INJECTION [PHYSICIANS TOTAL CARE, INC.]2
KETOROLAC TROMETHAMINEACTIVE INGREDIENT4EVE5946BQKETOROLAC TROMETHAMINE INJECTION [WOCKHARDT USA LLC]1
KETOROLACACTIVE MOIETYYZI5105V0LKETOROLAC TROMETHAMINE INJECTION [WOCKHARDT USA LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64679-758KETOROLAC TROMETHAMINE INJECTION [WOCKHARDT USA LLC.]4Legacy NDC20210515_b4b2ee9a-f59d-4c2f-878c-04a870e2a369.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665459ketorolac tromethamine 60 MG in 2 ML InjectionPSN63b51e87-a223-4d62-b94e-60adf48723762
16654592 ML ketorolac tromethamine 30 MG/ML InjectionSCD63b51e87-a223-4d62-b94e-60adf48723762
1665459ketorolac tromethamine 60 MG per 2 ML InjectionSY63b51e87-a223-4d62-b94e-60adf48723762

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
64679-758-026467907580225 VIAL, SINGLE-DOSE in 1 CARTON (64679-758-02) > 2 mL in 1 VIAL, SINGLE-DOSE (64679-758-10) 2007-03-270000-00-00NoNoCurrent