ketorolac tromethamine
- Product NDC
- 68071-2983
- 11-digit product format
- 680712983
- Labeler code
- 68071
- Product ID
- 68071-2983_33a10385-9c5e-478b-e063-6294a90a1a20
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ketorolac tromethamine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA217038
- Marketing category
- ANDA
- Marketing start
- 2022-11-10
- 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 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 |
|---|
| 68071-2983-2 | 68071298302 | 20 TABLET, FILM COATED in 1 BOTTLE (68071-2983-2) | 2023-06-19 | No | No | Historical |
| 68071-2983-8 | 68071298308 | 28 TABLET, FILM COATED in 1 BOTTLE (68071-2983-8) | 2025-04-25 | No | No | Historical |