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NDC 00641-6041-25 Ketorolac Tromethamine 15 mg/mL Details
Ketorolac Tromethamine 15 mg/mL
Ketorolac Tromethamine is a INTRAMUSCULAR; INTRAVENOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Hikma Pharmaceuticals USA Inc.. The primary component is KETOROLAC TROMETHAMINE.
MedlinePlus Drug Summary
Ketorolac is used to relieve moderately severe pain in adults, usually after surgery. Ketorolac is in a class of medications called NSAIDs. It works by stopping the body's production of a substance that causes pain, fever, and inflammation.
Related Packages: 00641-6041-25Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Ketorolac Injection
Product Information
| NDC | 00641-6041 |
|---|---|
| Product ID | 0641-6041_042c80ac-42f9-4f7a-bc40-f61d8e65449c |
| Associated GPIs | 66100037102015 |
| GCN Sequence Number | 039499 |
| GCN Sequence Number Description | ketorolac tromethamine VIAL 15 MG/ML INJECTION |
| HIC3 | S2B |
| HIC3 Description | NSAIDS, CYCLOOXYGENASE INHIBITOR TYPE ANALGESICS |
| GCN | 35238 |
| HICL Sequence Number | 005175 |
| HICL Sequence Number Description | KETOROLAC TROMETHAMINE |
| Brand/Generic | Generic |
| Proprietary Name | Ketorolac Tromethamine |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Ketorolac Tromethamine |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION |
| Route | INTRAMUSCULAR; INTRAVENOUS |
| Active Ingredient Strength | 15 |
| Active Ingredient Units | mg/mL |
| Substance Name | KETOROLAC TROMETHAMINE |
| Labeler Name | Hikma Pharmaceuticals USA Inc. |
| Pharmaceutical Class | Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA075772 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00641-6041-25 (00641604125)
| NDC Package Code | 0641-6041-25 |
|---|---|
| Billing NDC | 00641604125 |
| Package | 25 VIAL in 1 CARTON (0641-6041-25) / 1 mL in 1 VIAL (0641-6041-01) |
| Marketing Start Date | 2004-07-21 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |