Ketorolac Tromethamine
- Product NDC
- 17478-209
- 11-digit product format
- 174780209
- Labeler code
- 17478
- Product ID
- 17478-209_25d16426-8954-4341-96e6-108b1cbac0b5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ketorolac tromethamine
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- Akorn
- Application
- ANDA078434
- Marketing category
- ANDA
- Marketing start
- 2009-11-05
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 17478-209-10 | 2024-01-30 | C162847 | 48780-1 | 1030e365-6d15-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use KETOROLAC TROMETHAMINE OPHTHALMIC SOLUTION, 0.5% safely and effectively. See full prescribing information for KETOROLAC TROMETHAMINE OPHTHALMIC SOLUTION, 0.5%. KETOROLAC TROMETHAMINE ophthalmic solution, 0.5% Initial U.S. Approval: 1991 |
| 17478-209-11 | 2024-01-30 | C162847 | 48780-1 | 1030e365-6d15-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use KETOROLAC TROMETHAMINE OPHTHALMIC SOLUTION, 0.5% safely and effectively. See full prescribing information for KETOROLAC TROMETHAMINE OPHTHALMIC SOLUTION, 0.5%. KETOROLAC TROMETHAMINE ophthalmic solution, 0.5% Initial U.S. Approval: 1991 |
| 17478-209-19 | 2024-01-30 | C162847 | 48780-1 | 1030e365-6d15-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use KETOROLAC TROMETHAMINE OPHTHALMIC SOLUTION, 0.5% safely and effectively. See full prescribing information for KETOROLAC TROMETHAMINE OPHTHALMIC SOLUTION, 0.5%. KETOROLAC TROMETHAMINE ophthalmic solution, 0.5% Initial U.S. Approval: 1991 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 17478-209-10 | Ketorolac Tromethamine | 1 in 1 CARTON | SOLUTION | 1 | | 6 |
| 17478-209-10 | Ketorolac Tromethamine | 5 mL in 1 BOTTLE, DROPPER | SOLUTION | 5 | | 6 |
| 17478-209-11 | Ketorolac Tromethamine | 1 in 1 CARTON | SOLUTION | 1 | | 6 |
| 17478-209-11 | Ketorolac Tromethamine | 10 mL in 1 BOTTLE, DROPPER | SOLUTION | 10 | | 6 |
| 17478-209-19 | Ketorolac Tromethamine | 3 mL in 1 BOTTLE, DROPPER | SOLUTION | 3 | | 6 |
| 17478-209-19 | Ketorolac Tromethamine | 1 in 1 CARTON | SOLUTION | 1 | | 6 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 17478-209 | KETOROLAC TROMETHAMINE SOLUTION [AKORN] | 6 | Legacy NDC, 6 package rows | 20220201_3196b192-439c-4a71-a002-358efdd5b6e6.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 |
|---|
| 17478-209-10 | 17478020910 | 1 BOTTLE, DROPPER in 1 CARTON (17478-209-10) > 5 mL in 1 BOTTLE, DROPPER | 2009-11-05 | 0000-00-00 | No | No | Current |
| 17478-209-11 | 17478020911 | 1 BOTTLE, DROPPER in 1 CARTON (17478-209-11) > 10 mL in 1 BOTTLE, DROPPER | 2009-11-05 | 0000-00-00 | No | No | Current |
| 17478-209-19 | 17478020919 | 1 BOTTLE, DROPPER in 1 CARTON (17478-209-19) > 3 mL in 1 BOTTLE, DROPPER | 2009-11-05 | 0000-00-00 | No | No | Current |