Ketorolac Tromethamine
- Product NDC
- 62332-600
- 11-digit product format
- 623320600
- Labeler code
- 62332
- Product ID
- 62332-600_9030f496-5021-4454-ac16-dbb376315608
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ketorolac Tromethamine
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Alembic Pharmaceuticals Inc.
- Application
- ANDA214456
- Marketing category
- ANDA
- Marketing start
- 2022-11-02
- 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 |
|---|---|
| KETOROLAC TROMETHAMINE | 30 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 4EVE5946BQ |
| Rxcui | 860092, 1665459, 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 |
|---|---|---|---|---|---|---|
| 62332-600-01 | Ketorolac Tromethamine | 1 mL in 1 VIAL | INJECTION | 1 | 11 | |
| 62332-600-25 | Ketorolac Tromethamine | 25 in 1 CARTON | INJECTION | 25 | 11 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 62332-600-01 | ML - Milliliter | 62332-600 | 6f552dd3-b0af-417d-a72f-78ba11849e15 | 1 | 2023-05-05 |
| 62332-600-25 | ML - Milliliter | 62332-600 | bd23d3c5-34ff-44b0-aa44-248f9c9828cd | 1 | 2023-05-05 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 860092 | ketorolac tromethamine 15 MG in 1 ML Injection | PSN | 419cf756-3c96-4bb8-ae96-6aea5a5f3afd | 11 |
| 1665461 | ketorolac tromethamine 30 MG in 1 ML Injection | PSN | 419cf756-3c96-4bb8-ae96-6aea5a5f3afd | 11 |
| 1665459 | ketorolac tromethamine 60 MG in 2 ML Injection | PSN | 419cf756-3c96-4bb8-ae96-6aea5a5f3afd | 11 |
| 860092 | 1 ML ketorolac tromethamine 15 MG/ML Injection | SCD | 419cf756-3c96-4bb8-ae96-6aea5a5f3afd | 11 |
| 1665461 | 1 ML ketorolac tromethamine 30 MG/ML Injection | SCD | 419cf756-3c96-4bb8-ae96-6aea5a5f3afd | 11 |
| 1665459 | 2 ML ketorolac tromethamine 30 MG/ML Injection | SCD | 419cf756-3c96-4bb8-ae96-6aea5a5f3afd | 11 |
| 860092 | ketorolac tromethamine 15 MG per 1 ML Injection | SY | 419cf756-3c96-4bb8-ae96-6aea5a5f3afd | 11 |
| 1665461 | ketorolac tromethamine 30 MG per 1 ML Injection | SY | 419cf756-3c96-4bb8-ae96-6aea5a5f3afd | 11 |
| 1665459 | ketorolac tromethamine 60 MG per 2 ML Injection | SY | 419cf756-3c96-4bb8-ae96-6aea5a5f3afd | 11 |
| 1665461 | ketorolac tromethamine 30 MG in 1 ML Injection | PSN | 29003279-8f27-bcdc-e063-6394a90aa639 | 2 |
| 1665461 | ketorolac tromethamine 30 MG in 1 ML Injection | PSN | 3efb4f4e-b849-3bb5-e063-6394a90a5305 | 2 |
| 1665461 | 1 ML ketorolac tromethamine 30 MG/ML Injection | SCD | 29003279-8f27-bcdc-e063-6394a90aa639 | 2 |
| 1665461 | 1 ML ketorolac tromethamine 30 MG/ML Injection | SCD | 3efb4f4e-b849-3bb5-e063-6394a90a5305 | 2 |
| 1665461 | ketorolac tromethamine 30 MG per 1 ML Injection | SY | 29003279-8f27-bcdc-e063-6394a90aa639 | 2 |
| 1665461 | ketorolac tromethamine 30 MG per 1 ML Injection | SY | 3efb4f4e-b849-3bb5-e063-6394a90a5305 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 62332-600-01 | 62332060001 | 1 mL in 1 VIAL | 1 ml | Historical | ||||
| 62332-600-25 | 62332060025 | 25 VIAL in 1 CARTON (62332-600-25) / 1 mL in 1 VIAL (62332-600-01) | 25 vial | 2022-11-02 | 0000-00-00 | No | No | Current |