FDA.reportPublic FDA data

ketorolac tromethamine

Product NDC
72266-119
11-digit product format
722660119
Labeler code
72266
Product ID
72266-119_228ec94a-f777-f61b-e063-6394a90a21a5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ketorolac tromethamine
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
FOSUN PHARMA USA INC
Application
ANDA204216
Marketing category
ANDA
Marketing start
2023-06-23
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

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

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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
bb41bc3a-c643-93c9-055f-a8f48f363af3Product name220190219
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
4f6a8082-ae1e-0ff7-4dc0-77f9f0f7b70cProduct name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8d3e992f-8ff7-c106-f7eb-1e2d5eb12025Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72266-119-01ketorolac tromethamine2 mL in 1 VIALINJECTION, SOLUTION216
72266-119-25ketorolac tromethamine25 in 1 CARTONINJECTION, SOLUTION2516

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72266-119-01ML - Milliliter72266-119e9fc23fe-d969-4c71-8648-400974e2ebb512019-06-19
72266-119-25ML - Milliliter72266-1193713ca8a-f098-4d31-a2ac-6b246c2bf81a12019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72266-119KETOROLAC TROMETHAMINE INJECTION, SOLUTION [FOSUN PHARMA USA INC]16Current NDC, Legacy NDC, 2 package rows20250306_1aae6a4d-0909-4672-aa26-e3f2d8c4d413.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860092ketorolac tromethamine 15 MG in 1 ML InjectionPSN1aae6a4d-0909-4672-aa26-e3f2d8c4d41316
1665461ketorolac tromethamine 30 MG in 1 ML InjectionPSN1aae6a4d-0909-4672-aa26-e3f2d8c4d41316
1665459ketorolac tromethamine 60 MG in 2 ML InjectionPSN1aae6a4d-0909-4672-aa26-e3f2d8c4d41316
8600921 ML ketorolac tromethamine 15 MG/ML InjectionSCD1aae6a4d-0909-4672-aa26-e3f2d8c4d41316
16654611 ML ketorolac tromethamine 30 MG/ML InjectionSCD1aae6a4d-0909-4672-aa26-e3f2d8c4d41316
16654592 ML ketorolac tromethamine 30 MG/ML InjectionSCD1aae6a4d-0909-4672-aa26-e3f2d8c4d41316
860092ketorolac tromethamine 15 MG per 1 ML InjectionSY1aae6a4d-0909-4672-aa26-e3f2d8c4d41316
1665461ketorolac tromethamine 30 MG per 1 ML InjectionSY1aae6a4d-0909-4672-aa26-e3f2d8c4d41316
1665459ketorolac tromethamine 60 MG per 2 ML InjectionSY1aae6a4d-0909-4672-aa26-e3f2d8c4d41316
1665459ketorolac tromethamine 60 MG in 2 ML InjectionPSNe17f583d-8bd4-3ed0-e053-2a95a90a90905
16654592 ML ketorolac tromethamine 30 MG/ML InjectionSCDe17f583d-8bd4-3ed0-e053-2a95a90a90905
1665459ketorolac tromethamine 60 MG per 2 ML InjectionSYe17f583d-8bd4-3ed0-e053-2a95a90a90905
1665459ketorolac tromethamine 60 MG in 2 ML InjectionPSN26a1761b-90bf-49c6-9e6a-f293af2296ce4
1665459ketorolac tromethamine 60 MG in 2 ML InjectionPSN606b0f2f-de28-42a9-96f4-cacba2c7c56a4
16654592 ML ketorolac tromethamine 30 MG/ML InjectionSCD26a1761b-90bf-49c6-9e6a-f293af2296ce4
16654592 ML ketorolac tromethamine 30 MG/ML InjectionSCD606b0f2f-de28-42a9-96f4-cacba2c7c56a4
1665459ketorolac tromethamine 60 MG per 2 ML InjectionSY26a1761b-90bf-49c6-9e6a-f293af2296ce4
1665459ketorolac tromethamine 60 MG per 2 ML InjectionSY606b0f2f-de28-42a9-96f4-cacba2c7c56a4
1665459ketorolac tromethamine 60 MG in 2 ML InjectionPSN22de8e1c-5e68-fd78-e063-6394a90ad40b2
1665459ketorolac tromethamine 60 MG in 2 ML InjectionPSN2a23b0fa-803c-4abb-b588-12cfe83326a92
1665459ketorolac tromethamine 60 MG in 2 ML InjectionPSN42dfd39e-53a3-e9ee-e063-6394a90ab51e2
1665459ketorolac tromethamine 60 MG in 2 ML InjectionPSN9be407ba-651f-fa23-e053-2a95a90a6cf42
16654592 ML ketorolac tromethamine 30 MG/ML InjectionSCD2a23b0fa-803c-4abb-b588-12cfe83326a92
16654592 ML ketorolac tromethamine 30 MG/ML InjectionSCD42dfd39e-53a3-e9ee-e063-6394a90ab51e2
16654592 ML ketorolac tromethamine 30 MG/ML InjectionSCD22de8e1c-5e68-fd78-e063-6394a90ad40b2
16654592 ML ketorolac tromethamine 30 MG/ML InjectionSCD9be407ba-651f-fa23-e053-2a95a90a6cf42
1665459ketorolac tromethamine 60 MG per 2 ML InjectionSY2a23b0fa-803c-4abb-b588-12cfe83326a92
1665459ketorolac tromethamine 60 MG per 2 ML InjectionSY9be407ba-651f-fa23-e053-2a95a90a6cf42
1665459ketorolac tromethamine 60 MG per 2 ML InjectionSY42dfd39e-53a3-e9ee-e063-6394a90ab51e2
1665459ketorolac tromethamine 60 MG per 2 ML InjectionSY22de8e1c-5e68-fd78-e063-6394a90ad40b2
1665459ketorolac tromethamine 60 MG in 2 ML InjectionPSNee44c322-4b4b-4397-a1a5-e5b3c3c5a0531
16654592 ML ketorolac tromethamine 30 MG/ML InjectionSCDee44c322-4b4b-4397-a1a5-e5b3c3c5a0531
1665459ketorolac tromethamine 60 MG per 2 ML InjectionSYee44c322-4b4b-4397-a1a5-e5b3c3c5a0531

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72266-119-01722660119012 mL in 1 VIAL2 mlHistorical
72266-119-257226601192525 VIAL in 1 CARTON (72266-119-25) / 2 mL in 1 VIAL (72266-119-01) 25 vial2023-06-230000-00-00NoNoCurrent