FDA.reportPublic FDA data

KETOROLAC TROMETHAMINE

Product NDC
68462-756
11-digit product format
684620756
Labeler code
68462
Product ID
68462-756_13abaed4-8500-4f56-ae13-16803092fc78
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ketorolac tromethamine
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
GLENMARK PHARMACEUTICALS INC., USA
Application
ANDA217789
Marketing category
ANDA
Marketing start
2023-10-19
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
KETOROLAC TROMETHAMINE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
KETOROLAC TROMETHAMINE30 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
68462-756-01KETOROLAC TROMETHAMINE1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION14
68462-756-25KETOROLAC TROMETHAMINE25 in 1 CARTONINJECTION, SOLUTION254

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-756-01ML - Milliliter68462-756a5e8a3ab-4e79-454b-80f7-0eb776f5aa1212024-01-04
68462-756-25ML - Milliliter68462-756f94ecc42-198e-4727-bdcd-6fc12f95d8d612024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-756KETOROLAC TROMETHAMINE INJECTION, SOLUTION [GLENMARK PHARMACEUTICALS INC., USA]3Current NDC, 2 package rows20240718_ce992bee-a9f5-48bd-a00e-513f590d69f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860092ketorolac tromethamine 15 MG in 1 ML InjectionPSNce992bee-a9f5-48bd-a00e-513f590d69f24
1665461ketorolac tromethamine 30 MG in 1 ML InjectionPSNce992bee-a9f5-48bd-a00e-513f590d69f24
1665459ketorolac tromethamine 60 MG in 2 ML InjectionPSNce992bee-a9f5-48bd-a00e-513f590d69f24
8600921 ML ketorolac tromethamine 15 MG/ML InjectionSCDce992bee-a9f5-48bd-a00e-513f590d69f24
16654611 ML ketorolac tromethamine 30 MG/ML InjectionSCDce992bee-a9f5-48bd-a00e-513f590d69f24
16654592 ML ketorolac tromethamine 30 MG/ML InjectionSCDce992bee-a9f5-48bd-a00e-513f590d69f24
860092ketorolac tromethamine 15 MG per 1 ML InjectionSYce992bee-a9f5-48bd-a00e-513f590d69f24
1665461ketorolac tromethamine 30 MG per 1 ML InjectionSYce992bee-a9f5-48bd-a00e-513f590d69f24
1665459ketorolac tromethamine 60 MG per 2 ML InjectionSYce992bee-a9f5-48bd-a00e-513f590d69f24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68462-756-01684620756011 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
68462-756-256846207562525 VIAL, SINGLE-DOSE in 1 CARTON (68462-756-25) / 1 mL in 1 VIAL, SINGLE-DOSE (68462-756-01) 2023-10-19NoNoCurrent