Ketorolac Tromethamine
- Product NDC
- 43063-904
- 11-digit product format
- 430630904
- Labeler code
- 43063
- Product ID
- 43063-904_302be0ae-863f-db7d-e063-6294a90a1f9d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ketorolac Tromethamine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA074754
- Marketing category
- ANDA
- Marketing start
- 1998-06-17
- 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 |
|---|
| 43063-904-10 | 43063090410 | 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-904-10) | 2018-11-08 | No | No | Historical |
| 43063-904-15 | 43063090415 | 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-904-15) | 2018-12-11 | No | No | Historical |
| 43063-904-20 | 43063090420 | 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-904-20) | 2018-12-17 | No | No | Historical |
| 43063-904-30 | 43063090430 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-904-30) | 2024-09-10 | No | No | Historical |