FDA.reportPublic FDA data

Ketorolac Tromethamine

Product NDC
25021-701
11-digit product format
250210701
Labeler code
25021
Product ID
25021-701_cb23332a-48fa-458b-93ab-c4eef189a051
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ketorolac tromethamine
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA204216
Marketing category
ANDA
Marketing start
2014-09-05
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
2026-12-31

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
25021-701-01Ketorolac Tromethamine25 in 1 CARTONINJECTION, SOLUTION2515
25021-701-01Ketorolac Tromethamine1 mL in 1 VIALINJECTION, SOLUTION115
25021-701-02Ketorolac Tromethamine25 in 1 CARTONINJECTION, SOLUTION2515
25021-701-02Ketorolac Tromethamine2 mL in 1 VIALINJECTION, SOLUTION215

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-701-01ML - Milliliter25021-70139786ad5-1342-4703-a94b-ae3046e44d2212014-09-03
25021-701-02ML - Milliliter25021-701529929e7-ddbf-486c-9036-510049e7c42512014-09-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ketorolac tromethamineACTIVE INGREDIENT4EVE5946BQKETOROLAC TROMETHAMINE INJECTION, SOLUTION KETOROLAC TROMETHAMINE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]6
ketorolacACTIVE MOIETYYZI5105V0LKETOROLAC TROMETHAMINE INJECTION, SOLUTION KETOROLAC TROMETHAMINE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]6
alcoholINACTIVE INGREDIENT3K9958V90MKETOROLAC TROMETHAMINE INJECTION, SOLUTION KETOROLAC TROMETHAMINE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]6
hydrochloric acidINACTIVE INGREDIENTQTT17582CBKETOROLAC TROMETHAMINE INJECTION, SOLUTION KETOROLAC TROMETHAMINE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]6
sodium chlorideINACTIVE INGREDIENT451W47IQ8XKETOROLAC TROMETHAMINE INJECTION, SOLUTION KETOROLAC TROMETHAMINE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]6
sodium hydroxideINACTIVE INGREDIENT55X04QC32IKETOROLAC TROMETHAMINE INJECTION, SOLUTION KETOROLAC TROMETHAMINE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]6
waterINACTIVE INGREDIENT059QF0KO0RKETOROLAC TROMETHAMINE INJECTION, SOLUTION KETOROLAC TROMETHAMINE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-701KETOROLAC TROMETHAMINE INJECTION, SOLUTION KETOROLAC TROMETHAMINE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]13Current NDC, Legacy NDC, 4 package rows20230809_62591551-a644-4b2c-a0de-982e906fabc3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860092ketorolac tromethamine 15 MG in 1 ML InjectionPSN62591551-a644-4b2c-a0de-982e906fabc315
1665461ketorolac tromethamine 30 MG in 1 ML InjectionPSN62591551-a644-4b2c-a0de-982e906fabc315
1665459ketorolac tromethamine 60 MG in 2 ML InjectionPSN62591551-a644-4b2c-a0de-982e906fabc315
8600921 ML ketorolac tromethamine 15 MG/ML InjectionSCD62591551-a644-4b2c-a0de-982e906fabc315
16654611 ML ketorolac tromethamine 30 MG/ML InjectionSCD62591551-a644-4b2c-a0de-982e906fabc315
16654592 ML ketorolac tromethamine 30 MG/ML InjectionSCD62591551-a644-4b2c-a0de-982e906fabc315
860092ketorolac tromethamine 15 MG per 1 ML InjectionSY62591551-a644-4b2c-a0de-982e906fabc315
1665461ketorolac tromethamine 30 MG per 1 ML InjectionSY62591551-a644-4b2c-a0de-982e906fabc315
1665459ketorolac tromethamine 60 MG per 2 ML InjectionSY62591551-a644-4b2c-a0de-982e906fabc315
1665461ketorolac tromethamine 30 MG in 1 ML InjectionPSN3f2956d9-9e68-f35e-e063-6394a90a706d1
16654611 ML ketorolac tromethamine 30 MG/ML InjectionSCD3f2956d9-9e68-f35e-e063-6394a90a706d1
1665461ketorolac tromethamine 30 MG per 1 ML InjectionSY3f2956d9-9e68-f35e-e063-6394a90a706d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25021-701-012502107010125 VIAL in 1 CARTON (25021-701-01) / 1 mL in 1 VIAL25 vial2014-09-050000-00-00NoNoCurrent
25021-701-022502107010225 VIAL in 1 CARTON (25021-701-02) / 2 mL in 1 VIAL25 vial2014-09-050000-00-00NoNoCurrent