Ketorolac Tromethamine
- Product NDC
- 0409-3796
- 11-digit product format
- 004093796
- Labeler code
- 0409
- Product ID
- 0409-3796_572e3ce2-a27c-4a65-9593-84666518ddca
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- KETOROLAC TROMETHAMINE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR
- Labeler
- Hospira, Inc.
- Application
- ANDA074802
- Marketing category
- ANDA
- Marketing start
- 2015-10-30
- Substance
- KETOROLAC TROMETHAMINE
- Active strength
- 60 mg/2mL
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ketorolac Tromethamine
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| KETOROLAC TROMETHAMINE | 60 mg/2mL |
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 |
|---|
| 0409-3796-01 | Ketorolac Tromethamine | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | | 35 |
| 0409-3796-19 | Ketorolac Tromethamine | 2 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 2 | | 35 |
| 0409-3796-25 | Ketorolac Tromethamine | 25 in 1 CARTON | INJECTION, SOLUTION | 25 | | 35 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| KETOROLAC TROMETHAMINE | ACTIVE INGREDIENT | 4EVE5946BQ | KETOROLAC TROMETHAMINE INJECTION, SOLUTION [HOSPIRA, INC.] | 15 | |
| KETOROLAC | ACTIVE MOIETY | YZI5105V0L | KETOROLAC TROMETHAMINE INJECTION, SOLUTION [HOSPIRA, INC.] | 15 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | KETOROLAC TROMETHAMINE INJECTION, SOLUTION [HOSPIRA, INC.] | 15 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | KETOROLAC TROMETHAMINE INJECTION, SOLUTION [HOSPIRA, INC.] | 15 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | KETOROLAC TROMETHAMINE INJECTION, SOLUTION [HOSPIRA, INC.] | 15 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | KETOROLAC TROMETHAMINE INJECTION, SOLUTION [HOSPIRA, INC.] | 15 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | KETOROLAC TROMETHAMINE INJECTION, SOLUTION [HOSPIRA, INC.] | 15 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0409-3796 | KETOROLAC TROMETHAMINE INJECTION, SOLUTION [HOSPIRA, INC.] | 30 | Current NDC, Legacy NDC, 3 package rows | 20250129_8accbb78-fc64-45d5-69b0-35c23a1d2a2e.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 |
|---|
| 0409-3796-01 | 00409379601 | 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-3796-01) / 2 mL in 1 VIAL, SINGLE-DOSE (0409-3796-19) | | 2015-10-30 | 0000-00-00 | No | No | Current |
| 0409-3796-19 | 00409379619 | 2 mL in 1 VIAL, SINGLE-DOSE | 2 ml | | | | | Historical |
| 0409-3796-25 | 00409379625 | 25 VIAL, SINGLE-DOSE in 1 CARTON (0409-3796-25) / 2 mL in 1 VIAL, SINGLE-DOSE (0409-3796-19) | | 2025-01-27 | | No | No | Historical |