Ketorolac Tromethamine

Product NDC
82804-248
11-digit product format
828040248
Labeler code
82804
Product ID
82804-248_38fc11a0-50d1-4ba5-8d46-331eb74a00d6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketorolac Tromethamine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA216759
Marketing category
ANDA
Marketing start
2023-03-10
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

Related Records

Related UNII Ingredients

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

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82804-248-158280402481515 TABLET, FILM COATED in 1 BOTTLE (82804-248-15) 2025-10-15NoNoHistorical
82804-248-208280402482020 TABLET, FILM COATED in 1 BOTTLE (82804-248-20) 2025-10-15NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Ketorolac Tromethamine Tablets, USP Rx onlyProficient Rx LP2025-10-01HUMAN PRESCRIPTION DRUG LABEL1