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NDC 69344-0144-53 Sprix 15.75 mg/1 Details
Sprix 15.75 mg/1
Sprix is a NASAL SPRAY, METERED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Zyla Life Sciences US LLC. The primary component is KETOROLAC TROMETHAMINE.
MedlinePlus Drug Summary
Ketorolac nasal spray is used for the short-term relief of moderate to moderately severe pain. 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: 69344-0144-53Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Ketorolac Nasal Spray
Product Information
| NDC | 69344-0144 |
|---|---|
| Product ID | 69344-144_f1358780-ada4-44e5-8a19-54a729d14b38 |
| Associated GPIs | 66100037102090 |
| GCN Sequence Number | 067386 |
| GCN Sequence Number Description | ketorolac tromethamine SPRAY 15.75 MG NASAL |
| HIC3 | Q7K |
| HIC3 Description | NASAL NSAIDS, COX NON-SELECTIVE,SYSTEMIC ANALGESIC |
| GCN | 29928 |
| HICL Sequence Number | 005175 |
| HICL Sequence Number Description | KETOROLAC TROMETHAMINE |
| Brand/Generic | Brand |
| Proprietary Name | Sprix |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | ketorolac tromethamine |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SPRAY, METERED |
| Route | NASAL |
| Active Ingredient Strength | 15.75 |
| Active Ingredient Units | mg/1 |
| Substance Name | KETOROLAC TROMETHAMINE |
| Labeler Name | Zyla Life Sciences US 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 | NDA |
| Application Number | NDA022382 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 69344-0144-53 (69344014453)
| NDC Package Code | 69344-144-53 |
|---|---|
| Billing NDC | 69344014453 |
| Package | 1 BOTTLE, SPRAY in 1 CARTON (69344-144-53) / 8 SPRAY, METERED in 1 BOTTLE, SPRAY (69344-144-63) |
| Marketing Start Date | 2022-03-02 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |