Ketorolac Tromethamine
- Product NDC
- 80425-0267
- 11-digit product format
- 804250267
- Labeler code
- 80425
- Product ID
- 80425-0267_2a9ad9e4-1654-c0dc-e063-6294a90a6e45
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ketorolac Tromethamine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLC
- Application
- ANDA215788
- Marketing category
- ANDA
- Marketing start
- 2023-02-17
- 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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 4EVE5946BQ | KETOROLAC TROMETHAMINE | 74103-07-4 | KETOROLAC TROMETHAMINE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 80425-0267-1 | 80425026701 | 9 TABLET, FILM COATED in 1 BOTTLE (80425-0267-1) | 2023-02-17 | No | No | Historical |
| 80425-0267-2 | 80425026702 | 20 TABLET, FILM COATED in 1 BOTTLE (80425-0267-2) | 2023-02-17 | No | No | Historical |
| 80425-0267-3 | 80425026703 | 30 TABLET, FILM COATED in 1 BOTTLE (80425-0267-3) | 2023-02-17 | No | No | Historical |
| 80425-0267-4 | 80425026704 | 60 TABLET, FILM COATED in 1 BOTTLE (80425-0267-4) | 2023-02-17 | No | No | Historical |
| 80425-0267-5 | 80425026705 | 10 TABLET, FILM COATED in 1 BOTTLE (80425-0267-5) | 2023-03-30 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Ketorolac Tromethamine Tablets | Advanced Rx Pharmacy of Tennessee, LLC | 2024-12-31 | HUMAN PRESCRIPTION DRUG LABEL | 3 |