FDA.reportPublic FDA data

KETOROLAC TROMETHAMINE

Product NDC
0338-0069
11-digit product format
003380069
Labeler code
0338
Product ID
0338-0069_2da4dd8a-1b18-481d-b733-9c031d9ea7e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ketorolac tromethamine
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Baxter Healthcare Corporation
Application
ANDA209900
Marketing category
ANDA
Marketing start
2018-11-30
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
0338-0069-10KETOROLAC TROMETHAMINE10 in 1 CARTONINJECTION, SOLUTION1014
0338-0069-10KETOROLAC TROMETHAMINE1 mL in 1 VIALINJECTION, SOLUTION114

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-0069-10ML - Milliliter0338-0069486df2f7-56e5-46b8-acd0-885c7952d5a612019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0338-0069KETOROLAC TROMETHAMINE INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]13Current NDC, Legacy NDC, 2 package rows20240927_4b58836d-9d58-4539-9691-9e11c505ef2a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860092ketorolac tromethamine 15 MG in 1 ML InjectionPSN4b58836d-9d58-4539-9691-9e11c505ef2a14
1665461ketorolac tromethamine 30 MG in 1 ML InjectionPSN4b58836d-9d58-4539-9691-9e11c505ef2a14
1665459ketorolac tromethamine 60 MG in 2 ML InjectionPSN4b58836d-9d58-4539-9691-9e11c505ef2a14
8600921 ML ketorolac tromethamine 15 MG/ML InjectionSCD4b58836d-9d58-4539-9691-9e11c505ef2a14
16654611 ML ketorolac tromethamine 30 MG/ML InjectionSCD4b58836d-9d58-4539-9691-9e11c505ef2a14
16654592 ML ketorolac tromethamine 30 MG/ML InjectionSCD4b58836d-9d58-4539-9691-9e11c505ef2a14
860092ketorolac tromethamine 15 MG per 1 ML InjectionSY4b58836d-9d58-4539-9691-9e11c505ef2a14
1665461ketorolac tromethamine 30 MG per 1 ML InjectionSY4b58836d-9d58-4539-9691-9e11c505ef2a14
1665459ketorolac tromethamine 60 MG per 2 ML InjectionSY4b58836d-9d58-4539-9691-9e11c505ef2a14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0338-0069-100033800691010 VIAL in 1 CARTON (0338-0069-10) / 1 mL in 1 VIAL10 vial2018-11-300000-00-00NoNoCurrent