Ketorolac Tromethamine
- Product NDC
- 0641-6041
- 11-digit product format
- 006416041
- Labeler code
- 0641
- Product ID
- 0641-6041_25d6c438-45d2-4162-91c2-b5caa0f86bf3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ketorolac Tromethamine
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA075772
- Marketing category
- ANDA
- Marketing start
- 2004-07-21
- 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 |
|---|
| 0641-6041-01 | Ketorolac Tromethamine | 1 mL in 1 VIAL | INJECTION | 1 | | 13 |
| 0641-6041-25 | Ketorolac Tromethamine | 25 in 1 CARTON | INJECTION | 25 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0641-6041 | KETOROLAC TROMETHAMINE INJECTION [HIKMA PHARMACEUTICALS USA INC.] | 13 | Current NDC, Legacy NDC, 2 package rows | 20240411_0c2c75c9-ed7b-46a8-9543-429bf2d8f090.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 |
|---|
| 0641-6041-01 | 00641604101 | 1 mL in 1 VIAL | 1 ml | | | | | Historical |
| 0641-6041-25 | 00641604125 | 25 VIAL in 1 CARTON (0641-6041-25) / 1 mL in 1 VIAL (0641-6041-01) | 25 vial | 2004-07-21 | 0000-00-00 | No | No | Current |