Ketorolac Tromethamine
- Product NDC
- 71205-582
- 11-digit product format
- 712050582
- Labeler code
- 71205
- Product ID
- 71205-582_014ba8d7-7ed3-4d4a-847a-22b65161117e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ketorolac tromethamine
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Proficient Rx LP
- Application
- ANDA204216
- Marketing category
- ANDA
- Marketing start
- 2020-01-21
- 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 |
|---|
| 71205-582-01 | Ketorolac Tromethamine | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 1 |
| 71205-582-01 | Ketorolac Tromethamine | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71205-582 | KETOROLAC TROMETHAMINE INJECTION, SOLUTION [PROFICIENT RX LP] | 1 | Current NDC, Legacy NDC, 2 package rows | 20210715_014ba8d7-7ed3-4d4a-847a-22b65161117e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71205-582-01 | 71205058201 | 1 VIAL, SINGLE-DOSE in 1 CARTON (71205-582-01) / 1 mL in 1 VIAL, SINGLE-DOSE | 2021-07-12 | 0000-00-00 | No | No | Current |