ketorolac tromethamine
- Product NDC
- 50090-7808
- 11-digit product format
- 500907808
- Labeler code
- 50090
- Product ID
- 50090-7808_67a04f71-8022-4936-a8b3-54455e4c8178
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ketorolac tromethamine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA217038
- Marketing category
- ANDA
- Marketing start
- 2022-11-10
- Substance
- KETOROLAC TROMETHAMINE
- Active strength
- 10 mg/1
- 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 | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4EVE5946BQ |
| Rxcui | 834022 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-7808-0 | ketorolac tromethamine | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 1 |
| 50090-7808-3 | ketorolac tromethamine | 10 in 1 BOTTLE | TABLET, FILM COATED | 10 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 50090-7808-0 | 50090780800 | 20 TABLET, FILM COATED in 1 BOTTLE (50090-7808-0) | 2025-12-02 | No | No | Historical |
| 50090-7808-3 | 50090780803 | 10 TABLET, FILM COATED in 1 BOTTLE (50090-7808-3) | 2025-12-02 | No | No | Historical |