Ketorolac tromethamine
- Product NDC
- 50090-5428
- 11-digit product format
- 500905428
- Labeler code
- 50090
- Product ID
- 50090-5428_891f69bd-d76b-434d-8e4d-500efaa97b64
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ketorolac tromethamine
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- A-S Medication Solutions
- Application
- ANDA204216
- Marketing category
- ANDA
- Marketing start
- 2023-06-23
- 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 | 1665461 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-5428-0 | Ketorolac tromethamine | 25 in 1 CARTON | INJECTION, SOLUTION | 25 | | 13 |
| 50090-5428-0 | Ketorolac tromethamine | 1 mL in 1 VIAL | INJECTION, SOLUTION | 1 | | 13 |
| 50090-5428-1 | Ketorolac tromethamine | 1 mL in 1 VIAL | INJECTION, SOLUTION | 1 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-5428 | KETOROLAC TROMETHAMINE INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS] | 10 | Current NDC, Legacy NDC, 3 package rows | 20240612_5e42914f-de71-4176-819b-9fa26a8bdce6.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 |
|---|
| 50090-5428-0 | 50090542800 | 25 VIAL in 1 CARTON (50090-5428-0) / 1 mL in 1 VIAL | 25 vial | 2023-06-23 | 0000-00-00 | No | No | Current |
| 50090-5428-1 | 50090542801 | 1 mL in 1 VIAL (50090-5428-1) | 1 ml | 2023-06-23 | 0000-00-00 | No | No | Current |