ketorolac tromethamine
- Product NDC
- 70518-3800
- 11-digit product format
- 705183800
- Labeler code
- 70518
- Product ID
- 70518-3800_346893b1-a151-71ad-e063-6394a90ac2da
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ketorolac tromethamine
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA204216
- Marketing category
- ANDA
- Marketing start
- 2023-07-19
- 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 | 1665459 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-3800-0 | ketorolac tromethamine | 25 in 1 CARTON | INJECTION, SOLUTION | 25 | | 4 |
| 70518-3800-1 | ketorolac tromethamine | 2 mL in 1 VIAL | INJECTION, SOLUTION | 2 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-3800 | KETOROLAC TROMETHAMINE INJECTION, SOLUTION [REMEDYREPACK INC.] | 4 | Current NDC, 2 package rows | 20250507_26a1761b-90bf-49c6-9e6a-f293af2296ce.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 |
|---|
| 70518-3800-0 | 70518380000 | 25 VIAL in 1 CARTON (70518-3800-0) / 2 mL in 1 VIAL (70518-3800-1) | 25 vial | 2023-07-19 | No | No | Historical |
| 70518-3800-1 | 70518380001 | 2 mL in 1 VIAL | 2 ml | | | | Historical |