FDA.reportPublic FDA data

Ketorolac Tromethamine

Product NDC
63187-128
11-digit product format
631870128
Labeler code
63187
Product ID
63187-128_dd66f622-8f11-4a86-a70c-9a9a8300fda5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketorolac Tromethamine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA074754
Marketing category
ANDA
Marketing start
1998-06-17
Substance
KETOROLAC TROMETHAMINE
Active strength
10 mg/1
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 TROMETHAMINE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4EVE5946BQ
Rxcui834022

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
63187-128-10Ketorolac Tromethamine10 in 1 BOTTLETABLET, FILM COATED107
63187-128-12Ketorolac Tromethamine12 in 1 BOTTLETABLET, FILM COATED127
63187-128-15Ketorolac Tromethamine15 in 1 BOTTLETABLET, FILM COATED157
63187-128-20Ketorolac Tromethamine20 in 1 BOTTLETABLET, FILM COATED207
63187-128-30Ketorolac Tromethamine30 in 1 BOTTLETABLET, FILM COATED307
63187-128-60Ketorolac Tromethamine60 in 1 BOTTLETABLET, FILM COATED607
63187-128-90Ketorolac Tromethamine90 in 1 BOTTLETABLET, FILM COATED907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-128-10EA - Each63187-128f8211199-c6e8-4cd0-ac35-9e0897e24c2812022-05-04
63187-128-12EA - Each63187-12873d7527e-9572-42c0-8ea1-fd96d726809712022-03-09
63187-128-15EA - Each63187-1284b215fcb-c123-4859-b1d2-1ede08dafb6112016-09-02
63187-128-20EA - Each63187-1284b05093c-adae-4296-bc1c-1a56df01a24912026-02-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
KETOROLAC TROMETHAMINEACTIVE INGREDIENT4EVE5946BQKETOROLAC TROMETHAMINE TABLET, FILM COATED [PROFICIENT RX LP]1
KETOROLACACTIVE MOIETYYZI5105V0LKETOROLAC TROMETHAMINE TABLET, FILM COATED [PROFICIENT RX LP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UKETOROLAC TROMETHAMINE TABLET, FILM COATED [PROFICIENT RX LP]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PKETOROLAC TROMETHAMINE TABLET, FILM COATED [PROFICIENT RX LP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOKETOROLAC TROMETHAMINE TABLET, FILM COATED [PROFICIENT RX LP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XKETOROLAC TROMETHAMINE TABLET, FILM COATED [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30KETOROLAC TROMETHAMINE TABLET, FILM COATED [PROFICIENT RX LP]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AKETOROLAC TROMETHAMINE TABLET, FILM COATED [PROFICIENT RX LP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPKETOROLAC TROMETHAMINE TABLET, FILM COATED [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-128KETOROLAC TROMETHAMINE TABLET, FILM COATED [PROFICIENT RX LP]7Current NDC, Legacy NDC, 7 package rows20220409_f5170993-81a9-4eb7-95ac-60697a5ee1d7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834022ketorolac tromethamine 10 MG Oral TabletPSNf5170993-81a9-4eb7-95ac-60697a5ee1d77
834022ketorolac tromethamine 10 MG Oral TabletSCDf5170993-81a9-4eb7-95ac-60697a5ee1d77

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-128-106318701281010 TABLET, FILM COATED in 1 BOTTLE (63187-128-10) 2021-03-010000-00-00NoNoCurrent
63187-128-126318701281212 TABLET, FILM COATED in 1 BOTTLE (63187-128-12) 2022-02-080000-00-00NoNoCurrent
63187-128-156318701281515 TABLET, FILM COATED in 1 BOTTLE (63187-128-15) 2016-06-010000-00-00NoNoCurrent
63187-128-206318701282020 TABLET, FILM COATED in 1 BOTTLE (63187-128-20) 2014-07-060000-00-00NoNoCurrent
63187-128-306318701283030 TABLET, FILM COATED in 1 BOTTLE (63187-128-30) 2016-06-010000-00-00NoNoCurrent
63187-128-606318701286060 TABLET, FILM COATED in 1 BOTTLE (63187-128-60) 2016-06-010000-00-00NoNoCurrent
63187-128-906318701289090 TABLET, FILM COATED in 1 BOTTLE (63187-128-90) 2016-06-010000-00-00NoNoCurrent