Ketorolac Tromethamine
- Product NDC
- 72572-356
- 11-digit product format
- 725720356
- Labeler code
- 72572
- Product ID
- 72572-356_cc594527-566a-4fd8-944a-41e39918cbc3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ketorolac Tromethamine
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Civica, Inc.
- Application
- ANDA204216
- Marketing category
- ANDA
- Marketing start
- 2026-04-01
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ketorolac Tromethamine
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| KETOROLAC TROMETHAMINE | 15 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4EVE5946BQ |
| Rxcui | 860092, 1665461 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72572-356-01 | Ketorolac Tromethamine | 1 mL in 1 VIAL | INJECTION, SOLUTION | 1 | | 1 |
| 72572-356-25 | Ketorolac Tromethamine | 25 in 1 CARTON | INJECTION, SOLUTION | 25 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 72572-356-01 | 72572035601 | 1 mL in 1 VIAL | 1 ml | | | | Historical |
| 72572-356-25 | 72572035625 | 25 VIAL in 1 CARTON (72572-356-25) / 1 mL in 1 VIAL (72572-356-01) | 25 vial | 2026-04-01 | No | No | Historical |