Ketorolac Tromethamine
- Product NDC
- 63323-161
- 11-digit product format
- 633230161
- Labeler code
- 63323
- Product ID
- 63323-161_2b1c6066-d9e0-40a0-ade5-776fc35a3626
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- KETOROLAC TROMETHAMINE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA075784
- Marketing category
- ANDA
- Marketing start
- 2001-09-05
- 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, 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 |
|---|---|---|---|---|---|---|
| 63323-161-00 | Ketorolac Tromethamine | 1 mL in 1 VIAL, SINGLE-USE | INJECTION, SOLUTION | 1 | 8 | |
| 63323-161-01 | Ketorolac Tromethamine | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | 8 | |
| 63323-161-12 | Ketorolac Tromethamine | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | 6 | |
| 63323-161-21 | Ketorolac Tromethamine | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 1 | 6 | |
| 63323-161-16 | Ketorolac Tromethamine | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | 5 | |
| 63323-161-41 | Ketorolac Tromethamine | 1 mL in 1 VIAL, SINGLE-USE | INJECTION, SOLUTION | 1 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63323-161 | KETOROLAC TROMETHAMINE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 8 | Current NDC, Legacy NDC, 2 package rows | 20240730_d1920335-8e45-4960-b6e9-e6f1f9e6820c.zip |
| 63323-161 | KETOROLAC TROMETHAMINE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ] | 6 | Current NDC, Legacy NDC, 2 package rows | 20221208_950b7295-3f68-4027-ac2b-2f7d0f5f8ef9.zip |
| 63323-161 | KETOROLAC TROMETHAMINE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ] | 5 | Current NDC, Legacy NDC, 2 package rows | 20221117_ccf905ca-e164-4779-9485-2d139c821bad.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 860092 | ketorolac tromethamine 15 MG in 1 ML Injection | PSN | 6758cb38-dec8-468f-94e2-613772e39b9a | 9 |
| 860092 | 1 ML ketorolac tromethamine 15 MG/ML Injection | SCD | 6758cb38-dec8-468f-94e2-613772e39b9a | 9 |
| 860092 | ketorolac tromethamine 15 MG per 1 ML Injection | SY | 6758cb38-dec8-468f-94e2-613772e39b9a | 9 |
| 860092 | ketorolac tromethamine 15 MG in 1 ML Injection | PSN | d1920335-8e45-4960-b6e9-e6f1f9e6820c | 8 |
| 1665461 | ketorolac tromethamine 30 MG in 1 ML Injection | PSN | d1920335-8e45-4960-b6e9-e6f1f9e6820c | 8 |
| 1665459 | ketorolac tromethamine 60 MG in 2 ML Injection | PSN | d1920335-8e45-4960-b6e9-e6f1f9e6820c | 8 |
| 860092 | 1 ML ketorolac tromethamine 15 MG/ML Injection | SCD | d1920335-8e45-4960-b6e9-e6f1f9e6820c | 8 |
| 1665461 | 1 ML ketorolac tromethamine 30 MG/ML Injection | SCD | d1920335-8e45-4960-b6e9-e6f1f9e6820c | 8 |
| 1665459 | 2 ML ketorolac tromethamine 30 MG/ML Injection | SCD | d1920335-8e45-4960-b6e9-e6f1f9e6820c | 8 |
| 860092 | ketorolac tromethamine 15 MG per 1 ML Injection | SY | d1920335-8e45-4960-b6e9-e6f1f9e6820c | 8 |
| 1665461 | ketorolac tromethamine 30 MG per 1 ML Injection | SY | d1920335-8e45-4960-b6e9-e6f1f9e6820c | 8 |
| 1665459 | ketorolac tromethamine 60 MG per 2 ML Injection | SY | d1920335-8e45-4960-b6e9-e6f1f9e6820c | 8 |
| 860092 | ketorolac tromethamine 15 MG in 1 ML Injection | PSN | 950b7295-3f68-4027-ac2b-2f7d0f5f8ef9 | 6 |
| 1665461 | ketorolac tromethamine 30 MG in 1 ML Injection | PSN | 950b7295-3f68-4027-ac2b-2f7d0f5f8ef9 | 6 |
| 1665459 | ketorolac tromethamine 60 MG in 2 ML Injection | PSN | 950b7295-3f68-4027-ac2b-2f7d0f5f8ef9 | 6 |
| 860092 | 1 ML ketorolac tromethamine 15 MG/ML Injection | SCD | 950b7295-3f68-4027-ac2b-2f7d0f5f8ef9 | 6 |
| 1665461 | 1 ML ketorolac tromethamine 30 MG/ML Injection | SCD | 950b7295-3f68-4027-ac2b-2f7d0f5f8ef9 | 6 |
| 1665459 | 2 ML ketorolac tromethamine 30 MG/ML Injection | SCD | 950b7295-3f68-4027-ac2b-2f7d0f5f8ef9 | 6 |
| 860092 | ketorolac tromethamine 15 MG per 1 ML Injection | SY | 950b7295-3f68-4027-ac2b-2f7d0f5f8ef9 | 6 |
| 1665461 | ketorolac tromethamine 30 MG per 1 ML Injection | SY | 950b7295-3f68-4027-ac2b-2f7d0f5f8ef9 | 6 |
| 1665459 | ketorolac tromethamine 60 MG per 2 ML Injection | SY | 950b7295-3f68-4027-ac2b-2f7d0f5f8ef9 | 6 |
| 860092 | ketorolac tromethamine 15 MG in 1 ML Injection | PSN | ccf905ca-e164-4779-9485-2d139c821bad | 5 |
| 1665461 | ketorolac tromethamine 30 MG in 1 ML Injection | PSN | ccf905ca-e164-4779-9485-2d139c821bad | 5 |
| 1665459 | ketorolac tromethamine 60 MG in 2 ML Injection | PSN | ccf905ca-e164-4779-9485-2d139c821bad | 5 |
| 860092 | 1 ML ketorolac tromethamine 15 MG/ML Injection | SCD | ccf905ca-e164-4779-9485-2d139c821bad | 5 |
| 1665461 | 1 ML ketorolac tromethamine 30 MG/ML Injection | SCD | ccf905ca-e164-4779-9485-2d139c821bad | 5 |
| 1665459 | 2 ML ketorolac tromethamine 30 MG/ML Injection | SCD | ccf905ca-e164-4779-9485-2d139c821bad | 5 |
| 860092 | ketorolac tromethamine 15 MG per 1 ML Injection | SY | ccf905ca-e164-4779-9485-2d139c821bad | 5 |
| 1665461 | ketorolac tromethamine 30 MG per 1 ML Injection | SY | ccf905ca-e164-4779-9485-2d139c821bad | 5 |
| 1665459 | ketorolac tromethamine 60 MG per 2 ML Injection | SY | ccf905ca-e164-4779-9485-2d139c821bad | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63323-161-00 | 63323016100 | 1 mL in 1 VIAL, SINGLE-USE | 1 ml | Historical | ||||
| 63323-161-01 | 63323016101 | 25 VIAL, SINGLE-USE in 1 TRAY (63323-161-01) / 1 mL in 1 VIAL, SINGLE-USE (63323-161-00) | 2001-09-05 | 0000-00-00 | No | No | Current | |
| 63323-161-12 | 63323016112 | 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-161-12) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-161-21) | 2001-09-05 | 0000-00-00 | No | No | Current | |
| 63323-161-16 | 63323016116 | 25 VIAL, SINGLE-USE in 1 TRAY (63323-161-16) / 1 mL in 1 VIAL, SINGLE-USE (63323-161-41) | 2001-09-05 | 0000-00-00 | No | No | Current | |
| 63323-161-21 | 63323016121 | 1 mL in 1 VIAL, SINGLE-DOSE | 1 ml | Historical | ||||
| 63323-161-41 | 63323016141 | 1 mL in 1 VIAL, SINGLE-USE | 1 ml | Historical |