Ketorolac Tromethamine
- Product NDC
- 72189-583
- 11-digit product format
- 721890583
- Labeler code
- 72189
- Product ID
- 72189-583_4d3aadb1-8a83-d5ab-e063-6394a90a0267
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ketorolac Tromethamine
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR
- Labeler
- Direct_rx
- Application
- ANDA204216
- Marketing category
- ANDA
- Marketing start
- 2024-09-24
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ketorolac Tromethamine
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| KETOROLAC TROMETHAMINE | 30 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4EVE5946BQ |
| Rxcui | 1665459 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72189-583-01 | Ketorolac Tromethamine | 1 mL in 1 CARTON | INJECTION, SOLUTION | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72189-583 | KETOROLAC TROMETHAMINE INJECTION, SOLUTION [DIRECT_RX] | 1 | Current NDC, 1 package rows | 20240927_22de8e1c-5e68-fd78-e063-6394a90ad40b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 72189-583-01 | 72189058301 | 1 mL in 1 CARTON (72189-583-01) | 1 ml | 2024-09-24 | No | No | Current |