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NDC 76045-0105-20 Ketorolac Tromethamine 60 mg/2mL Details
Ketorolac Tromethamine 60 mg/2mL
Ketorolac Tromethamine is a INTRAMUSCULAR 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 | 76045-0105 |
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Product ID | 76045-105_0dab642d-7fcf-4301-8ac9-10e64a040c6b |
Associated GPIs | 66100037102071 |
GCN Sequence Number | 058309 |
GCN Sequence Number Description | ketorolac tromethamine SYRINGE 60 MG/2 ML INTRAMUSC |
HIC3 | S2B |
HIC3 Description | NSAIDS, CYCLOOXYGENASE INHIBITOR TYPE ANALGESICS |
GCN | 23724 |
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 |
Active Ingredient Strength | 60 |
Active Ingredient Units | mg/2mL |
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 76045-0105-20 (76045010520)
NDC Package Code | 76045-105-20 |
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Billing NDC | 76045010520 |
Package | 24 BLISTER PACK in 1 CARTON (76045-105-20) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 2 mL in 1 SYRINGE, GLASS |
Marketing Start Date | 2015-11-02 |
NDC Exclude Flag | N |
Pricing Information | N/A |