Ketorolac Tromethamine
- Product NDC
- 85766-064
- 11-digit product format
- 857660064
- Labeler code
- 85766
- Product ID
- 85766-064_502f1556-6d0f-82af-e063-6294a90ae206
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ketorolac Tromethamine
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Sportpharm LLC
- Application
- ANDA214456
- Marketing category
- ANDA
- Marketing start
- 2022-11-02
- Substance
- KETOROLAC TROMETHAMINE
- Active strength
- 30 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ketorolac Tromethamine
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| KETOROLAC TROMETHAMINE | 30 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4EVE5946BQ |
| Rxcui | 1665461 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 85766-064-01 | Ketorolac Tromethamine | 1 mL in 1 VIAL | INJECTION | 1 | | 2 |
| 85766-064-25 | Ketorolac Tromethamine | 25 in 1 CARTON | INJECTION | 25 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 85766-064-01 | 85766006401 | 1 mL in 1 VIAL | 1 ml | | | | Historical |
| 85766-064-25 | 85766006425 | 25 VIAL in 1 CARTON (85766-064-25) / 1 mL in 1 VIAL (85766-064-01) | 25 vial | 2025-09-17 | No | No | Historical |