KETOROLAC TROMETHAMINE
- Product NDC
- 55150-340
- 11-digit product format
- 551500340
- Labeler code
- 55150
- Product ID
- 55150-340_74f71a7a-b89a-4ad2-a19d-4f2fb87b040f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- KETOROLAC TROMETHAMINE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Eugia US LLC
- Application
- ANDA212939
- Marketing category
- ANDA
- Marketing start
- 2020-10-20
- 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
- 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 | 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 |
|---|
| 55150-340-01 | KETOROLAC TROMETHAMINE | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 1 | | 4 |
| 55150-340-01 | KETOROLAC TROMETHAMINE | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 4 |
| 55150-340-10 | KETOROLAC TROMETHAMINE | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 1 | | 4 |
| 55150-340-10 | KETOROLAC TROMETHAMINE | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 4 |
| 55150-340-25 | KETOROLAC TROMETHAMINE | 25 in 1 CARTON | INJECTION, SOLUTION | 25 | | 4 |
| 55150-340-25 | KETOROLAC TROMETHAMINE | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55150-340 | KETOROLAC TROMETHAMINE INJECTION, SOLUTION [EUGIA US LLC] | 4 | Current NDC, Legacy NDC, 6 package rows | 20240802_f520978f-9046-4ff8-b04d-0f615fdeae4d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55150-340-01 | 55150034001 | 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-340-01) / 1 mL in 1 VIAL, SINGLE-DOSE | 2020-10-20 | 0000-00-00 | No | No | Current |
| 55150-340-10 | 55150034010 | 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-340-10) / 1 mL in 1 VIAL, SINGLE-DOSE | 2020-10-20 | 0000-00-00 | No | No | Current |
| 55150-340-25 | 55150034025 | 25 VIAL, SINGLE-DOSE in 1 CARTON (55150-340-25) / 1 mL in 1 VIAL, SINGLE-DOSE | 2020-10-20 | 0000-00-00 | No | No | Current |