Ketorolac Tromethamine
- Product NDC
- 68071-3684
- 11-digit product format
- 680713684
- Labeler code
- 68071
- Product ID
- 68071-3684_2266e65b-4f99-374c-e063-6394a90ab332
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ketorolac Tromethamine
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- NuCare Pharmaceuticals, Inc.
- Application
- ANDA218204
- Marketing category
- ANDA
- Marketing start
- 2024-06-01
- 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 |
|---|
| 68071-3684-5 | Ketorolac Tromethamine | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 1 |
| 68071-3684-5 | Ketorolac Tromethamine | 5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 5 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-3684 | KETOROLAC TROMETHAMINE SOLUTION/ DROPS [NUCARE PHARMACEUTICALS, INC.] | 1 | Current NDC, 2 package rows | 20240920_2266e650-a0e9-027d-e063-6394a90a795d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68071-3684-5 | 68071368405 | 1 BOTTLE, DROPPER in 1 CARTON (68071-3684-5) / 5 mL in 1 BOTTLE, DROPPER | 2024-09-18 | No | No | Current |