Ketorolac Tromethamine

Product NDC
62332-600
11-digit product format
623320600
Labeler code
62332
Product ID
62332-600_9030f496-5021-4454-ac16-dbb376315608
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketorolac Tromethamine
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA214456
Marketing category
ANDA
Marketing start
2022-11-02
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

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
A214456-001KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2022-11-02
A214456-002KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2022-11-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A214456-001AP
A214456-002AP

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 · 50 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A214456-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2022-11-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214456-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2022-11-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214456-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2022-11-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214456-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2022-11-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A214456-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2022-11-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214456-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2022-11-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214456-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2022-11-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214456-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2022-11-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214456-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2022-11-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214456-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2022-11-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214456-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2022-11-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214456-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2022-11-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214456-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2022-11-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214456-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2022-11-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214456-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2022-11-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214456-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2022-11-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214456-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2022-11-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214456-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2022-11-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214456-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2022-11-02d06236e962d9…
2024-10-29 15:01 UTC2024-10A214456-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2022-11-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214456-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2022-11-0279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214456-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2022-11-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214456-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2022-11-02301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214456-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2022-11-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214456-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2022-11-021e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214456-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2022-11-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214456-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2022-11-028072bd15b7f6…
2024-05-31 18:47 UTC2024-05A214456-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2022-11-028072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214456-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2022-11-026a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214456-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2022-11-026a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A214456-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2022-11-021c564ffb4f44…
2024-02-18 07:12 UTC2024-02A214456-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2022-11-021c564ffb4f44…
2023-12-20 04:57 UTC2023-12A214456-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2022-11-02ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A214456-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2022-11-02ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A214456-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2022-11-02a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A214456-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2022-11-02a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A214456-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2022-11-029b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A214456-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2022-11-029b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A214456-001KETOROLAC TROMETHAMINE15MG/MLINJECTABLE / INJECTIONAP2022-11-02a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A214456-002KETOROLAC TROMETHAMINE30MG/MLINJECTABLE / INJECTIONAP2022-11-02a67488948f0b…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 50 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A214456-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214456-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214456-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214456-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A214456-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214456-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214456-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214456-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214456-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214456-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214456-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214456-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214456-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214456-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214456-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214456-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214456-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214456-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214456-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A214456-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214456-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214456-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214456-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214456-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214456-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214456-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214456-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A214456-002AP18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214456-001AP16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214456-002AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A214456-001AP11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A214456-002AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A214456-001AP1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A214456-002AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A214456-001AP1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A214456-002AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A214456-001AP19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A214456-002AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A214456-001AP1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A214456-002AP1a67488948f0b…

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
419cf756-3c96-4bb8-ae96-6aea5a5f3afdAvailable 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
62332-600-01Ketorolac Tromethamine1 mL in 1 VIALINJECTION111
62332-600-25Ketorolac Tromethamine25 in 1 CARTONINJECTION2511

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-600-01ML - Milliliter62332-6006f552dd3-b0af-417d-a72f-78ba11849e1512023-05-05
62332-600-25ML - Milliliter62332-600bd23d3c5-34ff-44b0-aa44-248f9c9828cd12023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-600KETOROLAC TROMETHAMINE INJECTION [ALEMBIC PHARMACEUTICALS INC.]11Current NDC, Legacy NDC, 2 package rows20240824_419cf756-3c96-4bb8-ae96-6aea5a5f3afd.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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ketorolac TromethamineKETOROLAC TROMETHAMINESportpharm LLC3efb4f4e-b849-3bb5-e063-6394a90a53052026-04-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214456
application number: ANDA214456
KETOROLAC TROMETHAMINEKETOROLAC TROMETHAMINEBaxter Healthcare Corporation30a3ca20-8f98-478c-8a6b-aa617f0a17a32026-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214456
application number: ANDA214456
Ketorolac TromethamineKETOROLAC TROMETHAMINEA-S Medication Solutions3321b610-1c9b-4314-adbb-a2e163234dec2025-11-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214456
application number: ANDA214456
Ketorolac TromethamineKETOROLAC TROMETHAMINEMedical Purchasing Solutions, LLC2900e69d-29ec-210a-e063-6294a90a50082024-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214456
application number: ANDA214456
Ketorolac TromethamineKETOROLAC TROMETHAMINEMedical Purchasing Solutions, LLC29003279-8f27-bcdc-e063-6394a90aa6392024-12-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214456
application number: ANDA214456
Ketorolac TromethamineKETOROLAC TROMETHAMINEAlembic Pharmaceuticals Inc.419cf756-3c96-4bb8-ae96-6aea5a5f3afd2024-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214456
application number: ANDA214456
ndc (product): 62332-600
Ketorolac TromethamineKETOROLAC TROMETHAMINEA-S Medication Solutionse0065781-ea33-4662-a8b1-c936e937ac9f2023-11-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214456
application number: ANDA214456

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860092ketorolac tromethamine 15 MG in 1 ML InjectionPSN419cf756-3c96-4bb8-ae96-6aea5a5f3afd11
1665461ketorolac tromethamine 30 MG in 1 ML InjectionPSN419cf756-3c96-4bb8-ae96-6aea5a5f3afd11
1665459ketorolac tromethamine 60 MG in 2 ML InjectionPSN419cf756-3c96-4bb8-ae96-6aea5a5f3afd11
8600921 ML ketorolac tromethamine 15 MG/ML InjectionSCD419cf756-3c96-4bb8-ae96-6aea5a5f3afd11
16654611 ML ketorolac tromethamine 30 MG/ML InjectionSCD419cf756-3c96-4bb8-ae96-6aea5a5f3afd11
16654592 ML ketorolac tromethamine 30 MG/ML InjectionSCD419cf756-3c96-4bb8-ae96-6aea5a5f3afd11
860092ketorolac tromethamine 15 MG per 1 ML InjectionSY419cf756-3c96-4bb8-ae96-6aea5a5f3afd11
1665461ketorolac tromethamine 30 MG per 1 ML InjectionSY419cf756-3c96-4bb8-ae96-6aea5a5f3afd11
1665459ketorolac tromethamine 60 MG per 2 ML InjectionSY419cf756-3c96-4bb8-ae96-6aea5a5f3afd11
1665461ketorolac tromethamine 30 MG in 1 ML InjectionPSN29003279-8f27-bcdc-e063-6394a90aa6392
1665461ketorolac tromethamine 30 MG in 1 ML InjectionPSN3efb4f4e-b849-3bb5-e063-6394a90a53052
16654611 ML ketorolac tromethamine 30 MG/ML InjectionSCD29003279-8f27-bcdc-e063-6394a90aa6392
16654611 ML ketorolac tromethamine 30 MG/ML InjectionSCD3efb4f4e-b849-3bb5-e063-6394a90a53052
1665461ketorolac tromethamine 30 MG per 1 ML InjectionSY29003279-8f27-bcdc-e063-6394a90aa6392
1665461ketorolac tromethamine 30 MG per 1 ML InjectionSY3efb4f4e-b849-3bb5-e063-6394a90a53052

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62332-600-01623320600011 mL in 1 VIAL1 mlHistorical
62332-600-256233206002525 VIAL in 1 CARTON (62332-600-25) / 1 mL in 1 VIAL (62332-600-01) 25 vial2022-11-020000-00-00NoNoCurrent