Ketorolac Tromethamine

Product NDC
53002-6990
11-digit product format
530026990
Labeler code
53002
Product ID
53002-6990_d0fb4bef-06a1-482a-991a-5668530fadd7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ketorolac Tromethamine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA074754
Marketing category
ANDA
Marketing start
1998-06-17
Marketing end
0000-00-00
Substance
KETOROLAC TROMETHAMINE
Active strength
10 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

Related Records

Related UNII Ingredients

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

Packages

Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53002-6990-15300269900110 TABLET, FILM COATED in 1 BOTTLE (53002-6990-1) 2018-10-010000-00-00NoNoCurrent
53002-6990-25300269900215 TABLET, FILM COATED in 1 BOTTLE (53002-6990-2) 2018-10-010000-00-00NoNoCurrent
53002-6990-35300269900320 TABLET, FILM COATED in 1 BOTTLE (53002-6990-3) 2018-10-010000-00-00NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Ketorolac Tromethamine Tablets USP, 10 mg Rx onlyRPK Pharmaceuticals, Inc.2023-06-07HUMAN PRESCRIPTION DRUG LABEL5