FDA.reportPublic FDA data

Ketorolac Tromethamine

Product NDC
43063-904
11-digit product format
430630904
Labeler code
43063
Product ID
43063-904_302be0ae-863f-db7d-e063-6294a90a1f9d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketorolac Tromethamine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
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
43063-904-10Ketorolac Tromethamine10 in 1 BOTTLE, PLASTICTABLET, FILM COATED1024
43063-904-15Ketorolac Tromethamine15 in 1 BOTTLE, PLASTICTABLET, FILM COATED1524
43063-904-20Ketorolac Tromethamine20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2024
43063-904-30Ketorolac Tromethamine30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-904-10EA - Each43063-904f770e6dc-ddd3-47f0-a37e-6739c64b8d0812019-01-24
43063-904-15EA - Each43063-9046e872a5f-0611-457c-946c-f6300cdb04fa12019-01-24
43063-904-20EA - Each43063-904dbef5f8b-db74-4ac8-8d01-98756da9918b12019-02-13
43063-904-30EA - Each43063-90429404dd8-7612-458d-bfd5-084ad140247f12024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-904KETOROLAC TROMETHAMINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]24Current NDC, Legacy NDC, 4 package rows20250315_add10ccd-c205-4512-9619-253290fa1152.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834022ketorolac tromethamine 10 MG Oral TabletPSNadd10ccd-c205-4512-9619-253290fa115224
834022ketorolac tromethamine 10 MG Oral TabletSCDadd10ccd-c205-4512-9619-253290fa115224

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-904-104306309041010 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-904-10) 2018-11-080000-00-00NoNoCurrent
43063-904-154306309041515 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-904-15) 2018-12-110000-00-00NoNoCurrent
43063-904-204306309042020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-904-20) 2018-12-170000-00-00NoNoCurrent
43063-904-304306309043030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-904-30) 2024-09-10NoNoCurrent