Ketorolac Tromethamine
- Product NDC
- 68071-3684
- 11-digit product format
- 680713684
- Labeler code
- 68071
- Product ID
- 68071-3684_2266e65b-4f99-374c-e063-6394a90ab332
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ketorolac Tromethamine
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- NuCare Pharmaceuticals, Inc.
- Application
- ANDA218204
- Marketing category
- ANDA
- Marketing start
- 2024-06-01
- 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
- 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 |
|---|
| 68071-3684-5 | 68071368405 | 1 BOTTLE, DROPPER in 1 CARTON (68071-3684-5) / 5 mL in 1 BOTTLE, DROPPER | 2024-09-18 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Ketorolac Tromethamine | NuCare Pharmaceuticals, Inc. | 2024-09-18 | HUMAN PRESCRIPTION DRUG LABEL | 1 |