FDA.reportPublic FDA data

ketorolac tromethamine

Product NDC
70710-1710
11-digit product format
707101710
Labeler code
70710
Product ID
70710-1710_80144a41-dfe6-4ba9-bb1b-f846873043ea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ketorolac tromethamine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zydus Pharmaceuticals (USA) Inc.
Application
ANDA217038
Marketing category
ANDA
Marketing start
2022-11-10
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
70710-1710-1ketorolac tromethamine100 in 1 BOTTLETABLET, FILM COATED1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70710-1710-1EA - Each70710-17101b615fbc-f337-4f20-8035-df5ee7f226ad12023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1710KETOROLAC TROMETHAMINE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]5Current NDC, Legacy NDC, 1 package rows20240807_ffd84ef3-26ed-4810-952b-4f0e913c5e32.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834022ketorolac tromethamine 10 MG Oral TabletPSNffd84ef3-26ed-4810-952b-4f0e913c5e325
834022ketorolac tromethamine 10 MG Oral TabletSCDffd84ef3-26ed-4810-952b-4f0e913c5e325
834022ketorolac tromethamine 10 MG Oral TabletPSNb0aa1137-d0c3-4e4e-b1ec-5fe4b24e570a3
834022ketorolac tromethamine 10 MG Oral TabletPSNfe7eb195-48be-753b-e053-6294a90a85003
834022ketorolac tromethamine 10 MG Oral TabletSCDb0aa1137-d0c3-4e4e-b1ec-5fe4b24e570a3
834022ketorolac tromethamine 10 MG Oral TabletSCDfe7eb195-48be-753b-e053-6294a90a85003
834022ketorolac tromethamine 10 MG Oral TabletPSN155c9171-d394-9c28-e063-6394a90a82091
834022ketorolac tromethamine 10 MG Oral TabletPSN23e7b5f7-ea0d-468d-9d13-a95f9bf605c61
834022ketorolac tromethamine 10 MG Oral TabletPSN51d443f8-716d-af3a-e063-6394a90a56a31
834022ketorolac tromethamine 10 MG Oral TabletPSNd8e928ac-c1e7-4b7a-87cd-9d11e36d53c01
834022ketorolac tromethamine 10 MG Oral TabletSCD155c9171-d394-9c28-e063-6394a90a82091
834022ketorolac tromethamine 10 MG Oral TabletSCD23e7b5f7-ea0d-468d-9d13-a95f9bf605c61
834022ketorolac tromethamine 10 MG Oral TabletSCD51d443f8-716d-af3a-e063-6394a90a56a31
834022ketorolac tromethamine 10 MG Oral TabletSCDd8e928ac-c1e7-4b7a-87cd-9d11e36d53c01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70710-1710-170710171001100 TABLET, FILM COATED in 1 BOTTLE (70710-1710-1) 2022-11-100000-00-00NoNoCurrent