ketorolac tromethamine
- Product NDC
- 68083-132
- 11-digit product format
- 680830132
- Labeler code
- 68083
- Product ID
- 68083-132_76e27d80-58bb-4ed8-ab33-4b1edd53ef20
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ketorolac tromethamine
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA204216
- Marketing category
- ANDA
- Marketing start
- 2016-12-01
- Substance
- KETOROLAC TROMETHAMINE
- Active strength
- 15 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 | 15 mg/mL |
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 |
|---|
| 68083-132-01 | ketorolac tromethamine | 1 mL in 1 VIAL | INJECTION, SOLUTION | 1 | | 15 |
| 68083-132-10 | ketorolac tromethamine | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 15 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-132 | KETOROLAC TROMETHAMINE INJECTION, SOLUTION [GLAND PHARMA LIMITED] | 15 | Current NDC, Legacy NDC, 2 package rows | 20240921_5abd4389-4fb2-408b-a27e-cf64b6a921f1.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 |
|---|
| 68083-132-01 | 68083013201 | 1 mL in 1 VIAL | 1 ml | | | | | Historical |
| 68083-132-10 | 68083013210 | 10 VIAL in 1 CARTON (68083-132-10) / 1 mL in 1 VIAL (68083-132-01) | 10 vial | 2016-12-01 | 0000-00-00 | No | No | Current |
| 68083-132-25 | 68083013225 | 25 VIAL in 1 CARTON (68083-132-25) > 1 mL in 1 VIAL (68083-132-01) | 25 vial | 2017-09-06 | 0000-00-00 | No | No | Current |