KETOROLAC TROMETHAMINE
- Product NDC
- 50090-3550
- 11-digit product format
- 500903550
- Labeler code
- 50090
- Product ID
- 50090-3550_a63c6172-9e50-4b41-9771-3203a41df0dc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ketorolac Tromethamine
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- A-S Medication Solutions
- Application
- NDA021528
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2013-11-21
- 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 |
|---|
| 50090-3550-0 | KETOROLAC TROMETHAMINE | 5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 5 | | 14 |
| 50090-3550-0 | KETOROLAC TROMETHAMINE | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 14 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-3550 | KETOROLAC TROMETHAMINE SOLUTION/ DROPS [A-S MEDICATION SOLUTIONS] | 14 | Current NDC, Legacy NDC, 2 package rows | 20240612_1580b751-15ff-4193-8f22-25a9a468989a.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 |
|---|
| 50090-3550-0 | 50090355000 | 1 BOTTLE, DROPPER in 1 CARTON (50090-3550-0) / 5 mL in 1 BOTTLE, DROPPER | 2018-08-23 | 0000-00-00 | No | No | Current |