Ketorolac Tromethamine
- Product NDC
- 70512-790
- 11-digit product format
- 705120790
- Labeler code
- 70512
- Product ID
- 70512-790_4572771c-8bb4-abe9-e063-6294a90a6c69
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ketorolac tromethamine
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- SOLA Pharmaceuticals, LLC
- Application
- ANDA218204
- Marketing category
- ANDA
- Marketing start
- 2024-04-15
- Substance
- KETOROLAC TROMETHAMINE
- Active strength
- 5 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 | 5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4EVE5946BQ |
| Rxcui | 860107 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70512-790-03 | Ketorolac Tromethamine | 3 mL in 1 BOTTLE, DROPPER | SOLUTION | 3 | | 3 |
| 70512-790-03 | Ketorolac Tromethamine | 1 in 1 CARTON | SOLUTION | 1 | | 3 |
| 70512-790-05 | Ketorolac Tromethamine | 1 in 1 CARTON | SOLUTION | 1 | | 3 |
| 70512-790-05 | Ketorolac Tromethamine | 5 mL in 1 BOTTLE, DROPPER | SOLUTION | 5 | | 3 |
| 70512-790-10 | Ketorolac Tromethamine | 1 in 1 CARTON | SOLUTION | 1 | | 3 |
| 70512-790-10 | Ketorolac Tromethamine | 10 mL in 1 BOTTLE, DROPPER | SOLUTION | 10 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70512-790 | KETOROLAC TROMETHAMINE SOLUTION [SOLA PHARMACEUTICALS, LLC] | 2 | Current NDC, 6 package rows | 20240425_b08a46f3-36c9-405d-a963-9739a5c87f9c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70512-790-03 | 70512079003 | 1 BOTTLE, DROPPER in 1 CARTON (70512-790-03) / 3 mL in 1 BOTTLE, DROPPER | 2024-04-15 | No | No | Current |
| 70512-790-05 | 70512079005 | 1 BOTTLE, DROPPER in 1 CARTON (70512-790-05) / 5 mL in 1 BOTTLE, DROPPER | 2024-04-15 | No | No | Current |
| 70512-790-10 | 70512079010 | 1 BOTTLE, DROPPER in 1 CARTON (70512-790-10) / 10 mL in 1 BOTTLE, DROPPER | 2024-04-15 | No | No | Current |