KETOROLAC TROMETHAMINE
- Product NDC
- 53002-7780
- 11-digit product format
- 530027780
- Labeler code
- 53002
- Product ID
- 53002-7780_f6996d93-ed57-4772-ae55-933ae1977f48
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ketorolac tromethamine
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA076583
- Marketing category
- ANDA
- Marketing start
- 2009-11-05
- Marketing end
- 0000-00-00
- Substance
- KETOROLAC TROMETHAMINE
- Active strength
- 5 mg/mL
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
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 | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 53002-7780-1 | 53002778001 | 5 mL in 1 BOTTLE, DROPPER (53002-7780-1) | 5 ml | 2021-01-01 | 0000-00-00 | No | No | Current |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| KETOROLAC TROMETHAMINE | RPK Pharmaceuticals, Inc. | 2022-03-30 | HUMAN PRESCRIPTION DRUG LABEL | 1 |