FDA.reportPublic FDA data

Ketorolac Tromethamine

Product NDC
21695-588
11-digit product format
216950588
Labeler code
21695
Product ID
21695-588_31da4540-1589-492c-8be6-382179e8ece2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketorolac Tromethamine
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Rebel Distributors Corp
Application
ANDA074993
Marketing category
ANDA
Marketing start
1999-01-27
Marketing end
0000-00-00
Substance
KETOROLAC TROMETHAMINE
Active strength
30 mg/mL
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-588-102019-09-24C16284748780-1934fe258-47c4-48b1-e053-8cdaa90a720aKetorolac Tromethamine Injection, USP
21695-588-252019-09-24C16284748780-1934fe258-47c4-48b1-e053-8cdaa90a720aKetorolac Tromethamine Injection, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-588-10Ketorolac Tromethamine1 mL in 1 CARTRIDGEINJECTION, SOLUTION11
21695-588-10Ketorolac Tromethamine10 in 1 BOXINJECTION, SOLUTION101
21695-588-25Ketorolac Tromethamine25 in 1 BOXINJECTION, SOLUTION251
21695-588-25Ketorolac Tromethamine1 mL in 1 CARTRIDGEINJECTION, SOLUTION11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-588-10ML - Milliliter21695-5882e21b51e-b43c-433a-af0b-fdaea148abf812012-07-24
21695-588-25ML - Milliliter21695-588472f4647-4c1d-4fe4-82cb-aad6c1fa80aa12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Ketorolac TromethamineACTIVE INGREDIENT4EVE5946BQKETOROLAC TROMETHAMINE INJECTION, SOLUTION [REBEL DISTRIBUTORS CORP]1
KetorolacACTIVE MOIETYYZI5105V0LKETOROLAC TROMETHAMINE INJECTION, SOLUTION [REBEL DISTRIBUTORS CORP]1
AlcoholINACTIVE INGREDIENT3K9958V90MKETOROLAC TROMETHAMINE INJECTION, SOLUTION [REBEL DISTRIBUTORS CORP]1
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBKETOROLAC TROMETHAMINE INJECTION, SOLUTION [REBEL DISTRIBUTORS CORP]1
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XKETOROLAC TROMETHAMINE INJECTION, SOLUTION [REBEL DISTRIBUTORS CORP]1
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IKETOROLAC TROMETHAMINE INJECTION, SOLUTION [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-588KETOROLAC TROMETHAMINE INJECTION, SOLUTION [REBEL DISTRIBUTORS CORP]1Legacy NDC, 4 package rows20110121_31da4540-1589-492c-8be6-382179e8ece2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665679ketorolac tromethamine 30 MG in 1 ML CartridgePSN31da4540-1589-492c-8be6-382179e8ece21
16656791 ML ketorolac tromethamine 30 MG/ML CartridgeSCD31da4540-1589-492c-8be6-382179e8ece21
1665679ketorolac tromethamine 30 MG per 1 ML CartridgeSY31da4540-1589-492c-8be6-382179e8ece21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
21695-588-10216950588101 mL in 1 CARTRIDGE1 mlHistorical
21695-588-252169505882525 in 1 BOXHistorical