KETOROLAC TROMETHAMINE
- Product NDC
- 83270-155
- 11-digit product format
- 832700155
- Labeler code
- 83270
- Product ID
- 83270-155_459667e8-a18d-b56f-e063-6294a90a34ef
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- KETOROLAC TROMETHAMINE
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR
- Labeler
- Onesource Specialty Pharma Limited
- Application
- ANDA078299
- Marketing category
- ANDA
- Marketing start
- 2023-09-30
- 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 | 860092, 1665459, 1665461 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 83270-155-03 | KETOROLAC TROMETHAMINE | 2 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 2 | | 1 |
| 83270-155-03 | KETOROLAC TROMETHAMINE | 25 in 1 CARTON | INJECTION | 25 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 83270-155-03 | 83270015503 | 25 VIAL, SINGLE-DOSE in 1 CARTON (83270-155-03) / 2 mL in 1 VIAL, SINGLE-DOSE | 2023-09-30 | No | No | Current |