Ketorolac Tromethamine
- Product NDC
- 72572-355
- 11-digit product format
- 725720355
- Labeler code
- 72572
- Product ID
- 72572-355_36757566-9551-4adc-8783-3f5054c370e8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- KETOROLAC TROMETHAMINE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Civica, Inc.
- Application
- ANDA209900
- Marketing category
- ANDA
- Marketing start
- 2023-03-25
- 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 | 860092, 1665461 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72572-355-01 | Ketorolac Tromethamine | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 1 | | 3 |
| 72572-355-25 | Ketorolac Tromethamine | 25 in 1 CARTON | INJECTION, SOLUTION | 25 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72572-355 | KETOROLAC TROMETHAMINE INJECTION, SOLUTION [CIVICA, INC.] | 3 | Current NDC, 2 package rows | 20241108_1e8ddf13-c513-4e16-a91a-9d55726d9071.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 72572-355-01 | 72572035501 | 1 mL in 1 VIAL, SINGLE-DOSE | 1 ml | | | | Historical |
| 72572-355-25 | 72572035525 | 25 VIAL, SINGLE-DOSE in 1 CARTON (72572-355-25) / 1 mL in 1 VIAL, SINGLE-DOSE (72572-355-01) | | 2023-03-25 | No | No | Historical |