FDA.reportPublic FDA data

Ketorolac Tromethamine

Product NDC
0409-2287
11-digit product format
004092287
Labeler code
0409
Product ID
0409-2287_85f893d5-95ce-4d57-a40e-bf41a974a09a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
KETOROLAC TROMETHAMINE
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Hospira, Inc.
Application
ANDA074993
Marketing category
ANDA
Marketing start
2005-04-28
Marketing end
0000-00-00
Substance
KETOROLAC TROMETHAMINE
Active strength
30 mg/mL
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-2287-03ML - Milliliter0409-22872d196875-39ee-476c-9f2e-dcde7d82a16c12017-07-07
0409-2287-04ML - Milliliter0409-228741dfd8f0-869a-4be4-acd2-e4ab75d5159412017-07-07
0409-2287-20ML - Milliliter0409-22871889a81d-42a5-4ceb-8ab8-5a80a44e4f5112016-12-07
0409-2287-21ML - Milliliter0409-2287b7598e31-3ffc-4124-aeb0-abec6d42650a12012-07-24
0409-2287-22ML - Milliliter0409-2287883be161-0d26-4890-9fa3-68932ee2f45512012-07-24
0409-2287-23ML - Milliliter0409-228745d5d1ff-940e-4463-8312-fec891beb0f212014-04-03
0409-2287-31ML - Milliliter0409-2287443a77b6-7c15-4377-9970-81285b25e64312012-07-24
0409-2287-61ML - Milliliter0409-2287980724c6-8348-4408-909b-ab16380f5fe412012-07-24

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 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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-2287-310040922873110 CARTRIDGE in 1 CARTON (0409-2287-31) > 1 mL in 1 CARTRIDGE (0409-2287-03) 10 cartridge2005-04-280000-00-00NoNoCurrent
0409-2287-610040922876110 CARTRIDGE in 1 CARTON (0409-2287-61) > 2 mL in 1 CARTRIDGE (0409-2287-04) 10 cartridge2005-06-230000-00-00NoNoCurrent