Ketorolac Tromethamine
- Product NDC
- 76420-184
- 11-digit product format
- 764200184
- Labeler code
- 76420
- Product ID
- 76420-184_eada7d08-38b8-4c19-e053-2995a90ae3ac
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- KETOROLAC TROMETHAMINE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA074802
- Marketing category
- ANDA
- Marketing start
- 2015-10-30
- 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 | 1665459 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76420-184-02 | Ketorolac Tromethamine | 2 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 2 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76420-184 | KETOROLAC TROMETHAMINE INJECTION, SOLUTION [ASCLEMED USA, INC.] | 2 | Current NDC, Legacy NDC, 1 package rows | 20230115_004588ba-e109-4a53-9c9d-a42dea9bb848.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 |
|---|
| 76420-184-02 | 76420018402 | 2 mL in 1 VIAL, SINGLE-DOSE (76420-184-02) | 2 ml | 2020-11-18 | 0000-00-00 | No | No | Current |