Ketorolac Tromethamine

Product NDC
68788-8701
11-digit product format
687888701
Labeler code
68788
Product ID
68788-8701_9ab00e36-ba3e-4417-8552-85cd59daa5f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketorolac Tromethamine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA216759
Marketing category
ANDA
Marketing start
2024-06-27
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
2027-12-31
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
68788-8701-26878887010220 TABLET, FILM COATED in 1 BOTTLE (68788-8701-2) 2024-06-27NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Ketorolac Tromethamine Tablets, USP Rx onlyPreferred Pharmaceuticals Inc.2026-05-15HUMAN PRESCRIPTION DRUG LABEL3