Ketorolac Tromethamine
- Product NDC
- 55154-6960
- 11-digit product format
- 551546960
- Labeler code
- 55154
- Product ID
- 55154-6960_c4345cef-6211-46b5-afc2-b0a5e84f94da
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- KETOROLAC TROMETHAMINE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Cardinal Health 107, LLC
- Application
- ANDA074802
- Marketing category
- ANDA
- Marketing start
- 2011-07-27
- Substance
- KETOROLAC TROMETHAMINE
- Active strength
- 15 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 |
|---|---|
| KETOROLAC TROMETHAMINE | 15 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 4EVE5946BQ |
| Rxcui | 860092, 1665461 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6a38bd75-79e3-96c0-1204-08a0282902ae | Product name | 4 | 20250128 |
| 4d6e22a5-3693-6edf-0179-2ab93aecbadb | Product name | 9 | 20240724 |
| 03452e68-2506-686e-a908-f2381c778fc6 | Product name | 5 | 20240307 |
| b5abe2e3-39a1-43eb-9bff-f3c1653fe3df | Product name | 2 | 20190930 |
| bb41bc3a-c643-93c9-055f-a8f48f363af3 | Product name | 2 | 20190219 |
| 4f6a8082-ae1e-0ff7-4dc0-77f9f0f7b70c | Product name | 1 | 20140508 |
| 8d3e992f-8ff7-c106-f7eb-1e2d5eb12025 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55154-6960-5 | Ketorolac Tromethamine | 5 in 1 BAG | INJECTION, SOLUTION | 5 | 20 | |
| 55154-6960-5 | Ketorolac Tromethamine | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 1 | 20 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 55154-6960-5 | ML - Milliliter | 55154-6960 | 89fec265-5eb3-4410-9a9d-9dc794cb30eb | 1 | 2020-03-10 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| KETOROLAC TROMETHAMINE | ACTIVE INGREDIENT | 4EVE5946BQ | KETOROLAC TROMETHAMINE INJECTION, SOLUTION [CARDINAL HEALTH] | 6 | |
| KETOROLAC | ACTIVE MOIETY | YZI5105V0L | KETOROLAC TROMETHAMINE INJECTION, SOLUTION [CARDINAL HEALTH] | 6 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | KETOROLAC TROMETHAMINE INJECTION, SOLUTION [CARDINAL HEALTH] | 6 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | KETOROLAC TROMETHAMINE INJECTION, SOLUTION [CARDINAL HEALTH] | 6 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | KETOROLAC TROMETHAMINE INJECTION, SOLUTION [CARDINAL HEALTH] | 6 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | KETOROLAC TROMETHAMINE INJECTION, SOLUTION [CARDINAL HEALTH] | 6 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | KETOROLAC TROMETHAMINE INJECTION, SOLUTION [CARDINAL HEALTH] | 6 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55154-6960 | KETOROLAC TROMETHAMINE INJECTION, SOLUTION [CARDINAL HEALTH 107, LLC] | 20 | Current NDC, Legacy NDC, 2 package rows | 20250124_dd489c86-08c0-4457-86f3-c4f36a70276c.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 860092 | ketorolac tromethamine 15 MG in 1 ML Injection | PSN | dd489c86-08c0-4457-86f3-c4f36a70276c | 20 |
| 1665461 | ketorolac tromethamine 30 MG in 1 ML Injection | PSN | dd489c86-08c0-4457-86f3-c4f36a70276c | 20 |
| 860092 | 1 ML ketorolac tromethamine 15 MG/ML Injection | SCD | dd489c86-08c0-4457-86f3-c4f36a70276c | 20 |
| 1665461 | 1 ML ketorolac tromethamine 30 MG/ML Injection | SCD | dd489c86-08c0-4457-86f3-c4f36a70276c | 20 |
| 860092 | ketorolac tromethamine 15 MG per 1 ML Injection | SY | dd489c86-08c0-4457-86f3-c4f36a70276c | 20 |
| 1665461 | ketorolac tromethamine 30 MG per 1 ML Injection | SY | dd489c86-08c0-4457-86f3-c4f36a70276c | 20 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 55154-6960-5 | 55154696005 | 5 VIAL, SINGLE-DOSE in 1 BAG (55154-6960-5) / 1 mL in 1 VIAL, SINGLE-DOSE | 2011-07-27 | 0000-00-00 | No | No | Current |