Ketorolac Tromethamine
- Product NDC
- 65862-775
- 11-digit product format
- 658620775
- Labeler code
- 65862
- Product ID
- 65862-775_ffe3b63b-abfc-455b-bc6c-49cd58e406e0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ketorolac Tromethamine
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA205191
- Marketing category
- ANDA
- Marketing start
- 2018-11-15
- Substance
- KETOROLAC TROMETHAMINE
- Active strength
- 4 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 | 4 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4EVE5946BQ |
| Rxcui | 860103 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65862-775-05 | Ketorolac Tromethamine | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 6 |
| 65862-775-05 | Ketorolac Tromethamine | 5 mL in 1 BOTTLE | SOLUTION/ DROPS | 5 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65862-775 | KETOROLAC TROMETHAMINE SOLUTION/ DROPS [AUROBINDO PHARMA LIMITED] | 6 | Current NDC, Legacy NDC, 2 package rows | 20240830_e93f6501-827d-474c-b660-765b7c0fb871.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 |
|---|
| 65862-775-05 | 65862077505 | 1 BOTTLE in 1 CARTON (65862-775-05) / 5 mL in 1 BOTTLE | 1 bottle | 2018-11-15 | 0000-00-00 | No | No | Current |