FDA.reportPublic FDA data

Ketorolac Tromethamine

Product NDC
62332-599
11-digit product format
623320599
Labeler code
62332
Product ID
62332-599_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
15 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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
KETOROLAC TROMETHAMINE15 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4EVE5946BQ
Rxcui860092, 1665459, 1665461

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
62332-599-01Ketorolac Tromethamine1 mL in 1 VIALINJECTION111
62332-599-25Ketorolac Tromethamine25 in 1 CARTONINJECTION2511

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-599-01ML - Milliliter62332-5995d2c8c9c-ddc0-42e1-8122-50175dbea7ca12023-05-05
62332-599-25ML - Milliliter62332-5999126863a-95e1-41bd-b3bd-ed9b2259d19612023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-599KETOROLAC TROMETHAMINE INJECTION [ALEMBIC PHARMACEUTICALS INC.]11Current NDC, Legacy NDC, 2 package rows20240824_419cf756-3c96-4bb8-ae96-6aea5a5f3afd.zip

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
860092ketorolac tromethamine 15 MG in 1 ML InjectionPSNe0065781-ea33-4662-a8b1-c936e937ac9f1
8600921 ML ketorolac tromethamine 15 MG/ML InjectionSCDe0065781-ea33-4662-a8b1-c936e937ac9f1
860092ketorolac tromethamine 15 MG per 1 ML InjectionSYe0065781-ea33-4662-a8b1-c936e937ac9f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62332-599-01623320599011 mL in 1 VIAL1 mlHistorical
62332-599-256233205992525 VIAL in 1 CARTON (62332-599-25) / 1 mL in 1 VIAL (62332-599-01) 25 vial2022-11-020000-00-00NoNoCurrent