Ketorolac Tromethamine

Product NDC
68788-8891
11-digit product format
687888891
Labeler code
68788
Product ID
68788-8891_18b450d2-e715-4710-a1d8-22b782f87f9c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ketorolac tromethamine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA215788
Marketing category
ANDA
Marketing start
2025-09-23
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
4EVE5946BQKETOROLAC TROMETHAMINE74103-07-4KETOROLAC TROMETHAMINE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8891-26878888910220 TABLET, FILM COATED in 1 BOTTLE (68788-8891-2) 2025-09-23NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Ketorolac Tromethamine Tablets USP, 10 mgPreferred Pharmaceuticals Inc.2025-09-23HUMAN PRESCRIPTION DRUG LABEL1