KETOROLAC TROMETHAMINE
- Product NDC
- 43066-051
- 11-digit product format
- 430660051
- Labeler code
- 43066
- Product ID
- 43066-051_30a3ca20-8f98-478c-8a6b-aa617f0a17a3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ketorolac tromethamine
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Baxter Healthcare Corporation
- Application
- ANDA214456
- Marketing category
- ANDA
- Marketing start
- 2026-05-19
- 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 | 860092, 1665459, 1665461 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43066-051-01 | KETOROLAC TROMETHAMINE | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 1 | | 1 |
| 43066-051-10 | KETOROLAC TROMETHAMINE | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 43066-051-01 | 43066005101 | 1 mL in 1 VIAL, SINGLE-DOSE | 1 ml | | | | Historical |
| 43066-051-10 | 43066005110 | 10 VIAL, SINGLE-DOSE in 1 CARTON (43066-051-10) / 1 mL in 1 VIAL, SINGLE-DOSE (43066-051-01) | | 2026-05-19 | No | No | Current |