ketorolac tromethamine
- Product NDC
- 47335-934
- 11-digit product format
- 473350934
- Labeler code
- 47335
- Product ID
- 47335-934_4d86168f-6d0f-4338-8e59-9ad241a9fadb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ketorolac tromethamine
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA078737
- Marketing category
- ANDA
- Marketing start
- 2022-12-25
- Substance
- KETOROLAC TROMETHAMINE
- Active strength
- 30 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 | 30 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4EVE5946BQ |
| Rxcui | 860092, 1665459, 1665461 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 47335-934-40 | ketorolac tromethamine | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 1 | | 9 |
| 47335-934-45 | ketorolac tromethamine | 25 in 1 CARTON | INJECTION | 25 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 47335-934 | KETOROLAC TROMETHAMINE INJECTION [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 9 | Current NDC, Legacy NDC, 2 package rows | 20240805_29a92a7c-68d1-489b-ba27-d788b3153795.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 |
|---|
| 47335-934-40 | 47335093440 | 1 mL in 1 VIAL, SINGLE-DOSE | 1 ml | | | | | Historical |
| 47335-934-45 | 47335093445 | 25 VIAL, SINGLE-DOSE in 1 CARTON (47335-934-45) / 1 mL in 1 VIAL, SINGLE-DOSE (47335-934-40) | | 2022-12-25 | 0000-00-00 | No | No | Current |