Ketorolac Tromethamine
- Product NDC
- 42571-137
- 11-digit product format
- 425710137
- Labeler code
- 42571
- Product ID
- 42571-137_3febb42b-8d54-b958-e063-6394a90acea3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ketorolac Tromethamine
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- Micro Labs Limited
- Application
- ANDA203410
- Marketing category
- ANDA
- Marketing start
- 2019-06-03
- 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 |
|---|
| 42571-137-25 | Ketorolac Tromethamine | 5 mL in 1 BOTTLE | SOLUTION | 5 | | 8 |
| 42571-137-26 | Ketorolac Tromethamine | 10 mL in 1 BOTTLE | SOLUTION | 10 | | 8 |
| 42571-137-31 | Ketorolac Tromethamine | 3 mL in 1 BOTTLE | SOLUTION | 3 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42571-137 | KETOROLAC TROMETHAMINE (KETOROLAC TROMETHAMINE) SOLUTION [MICRO LABS LIMITED] | 7 | Current NDC, Legacy NDC, 3 package rows | 20241004_631c2c31-cd4f-4a17-85c6-be96746a753e.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 |
|---|
| 42571-137-25 | 42571013725 | 5 mL in 1 BOTTLE (42571-137-25) | 5 ml | 2019-06-03 | 0000-00-00 | No | No | Current |
| 42571-137-26 | 42571013726 | 10 mL in 1 BOTTLE (42571-137-26) | 10 ml | 2019-06-03 | 0000-00-00 | No | No | Current |
| 42571-137-31 | 42571013731 | 3 mL in 1 BOTTLE (42571-137-31) | 3 ml | 2019-06-03 | 0000-00-00 | No | No | Current |