KETOROLAC TROMETHAMINE
- Product NDC
- 51662-1594
- 11-digit product format
- 516621594
- Labeler code
- 51662
- Product ID
- 51662-1594_0ffa38dd-8b40-d947-e063-6294a90a608e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- KETOROLAC TROMETHAMINE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR
- Labeler
- HF Acquisition Co LLC, DBA HealthFirst
- Application
- ANDA075784
- Marketing category
- ANDA
- Marketing start
- 2022-07-22
- 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 | 1665461 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51662-1594-2 | KETOROLAC TROMETHAMINE | 1 in 1 POUCH | INJECTION, SOLUTION | 1 | | 2 |
| 51662-1594-2 | KETOROLAC TROMETHAMINE | 1 mL in 1 VIAL, SINGLE-USE | INJECTION, SOLUTION | 1 | | 2 |
| 51662-1594-3 | KETOROLAC TROMETHAMINE | 25 in 1 CASE | INJECTION, SOLUTION | 25 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51662-1594 | KETOROLAC TROMETHAMINE INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] | 2 | Current NDC, Legacy NDC, 3 package rows | 20240129_e46ebc7f-584e-e2b7-e053-2995a90ad17b.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 |
|---|
| 51662-1594-2 | 51662159402 | 1 in 1 POUCH | | | | | | Historical |
| 51662-1594-3 | 51662159403 | 25 POUCH in 1 CASE (51662-1594-3) / 1 VIAL, SINGLE-USE in 1 POUCH (51662-1594-2) / 1 mL in 1 VIAL, SINGLE-USE | 25 pouch | 2022-07-22 | 0000-00-00 | No | No | Current |