Ketorolac Tromethamine
- Product NDC
- 76045-105
- 11-digit product format
- 760450105
- Labeler code
- 76045
- Product ID
- 76045-105_0dab642d-7fcf-4301-8ac9-10e64a040c6b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ketorolac Tromethamine
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA203242
- Marketing category
- ANDA
- Marketing start
- 2015-11-02
- Substance
- KETOROLAC TROMETHAMINE
- Active strength
- 60 mg/2mL
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ketorolac Tromethamine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| KETOROLAC TROMETHAMINE | 60 mg/2mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4EVE5946BQ |
| Rxcui | 860113, 860114, 860115 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76045-105-20 | Ketorolac Tromethamine | 24 in 1 CARTON | INJECTION, SOLUTION | 24 | | 17 |
| 76045-105-20 | Ketorolac Tromethamine | 1 in 1 BLISTER PACK | INJECTION, SOLUTION | 1 | | 17 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76045-105 | KETOROLAC TROMETHAMINE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 17 | Current NDC, Legacy NDC, 2 package rows | 20230910_3d88cbe6-5230-47aa-80af-0c41283d1f00.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 76045-105-20 | 76045010520 | 24 BLISTER PACK in 1 CARTON (76045-105-20) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 2 mL in 1 SYRINGE, GLASS | 24 blister pack | 2015-11-02 | 0000-00-00 | No | No | Current |