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NDC 76045-0107-10 Ketorolac Tromethamine 15 mg/mL Details
Ketorolac Tromethamine 15 mg/mL
Ketorolac Tromethamine is a INTRAMUSCULAR; INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Fresenius Kabi USA, LLC. The primary component is KETOROLAC TROMETHAMINE.
Product Information
| NDC | 76045-0107 |
|---|---|
| Product ID | 76045-107_0dab642d-7fcf-4301-8ac9-10e64a040c6b |
| Associated GPIs | 66100037102015 |
| GCN Sequence Number | 036311 |
| GCN Sequence Number Description | ketorolac tromethamine SYRINGE 15 MG/ML INJECTION |
| HIC3 | S2B |
| HIC3 Description | NSAIDS, CYCLOOXYGENASE INHIBITOR TYPE ANALGESICS |
| GCN | 96508 |
| 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, SOLUTION |
| Route | INTRAMUSCULAR; INTRAVENOUS |
| Active Ingredient Strength | 15 |
| Active Ingredient Units | mg/mL |
| Substance Name | KETOROLAC TROMETHAMINE |
| Labeler Name | Fresenius Kabi USA, LLC |
| 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 | ANDA203242 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 76045-0107-10 (76045010710)
| NDC Package Code | 76045-107-10 |
|---|---|
| Billing NDC | 76045010710 |
| Package | 24 BLISTER PACK in 1 CARTON (76045-107-10) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS |
| Marketing Start Date | 2015-11-02 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |