Ketorolac Tromethamine
- Product NDC
- 47335-221
- 11-digit product format
- 473350221
- Labeler code
- 47335
- Product ID
- 47335-221_26b840cb-75b8-41f1-bcbb-287a0b2eca52
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ketorolac Tromethamine
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA090017
- Marketing category
- ANDA
- Marketing start
- 2018-03-13
- 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 |
|---|
| 47335-221-90 | Ketorolac Tromethamine | 10 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 10 | | 5 |
| 47335-221-90 | Ketorolac Tromethamine | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 47335-221 | KETOROLAC TROMETHAMINE SOLUTION/ DROPS [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20181024_2c76b8f9-5385-4c98-aebb-bdca8613d24b.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 |
|---|
| 47335-221-90 | 47335022190 | 1 BOTTLE, DROPPER in 1 CARTON (47335-221-90) / 10 mL in 1 BOTTLE, DROPPER | 2018-03-13 | 0000-00-00 | No | No | Current |