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NDC 64380-0997-03 Ibuprofen 100 mg/5mL Details
Ibuprofen 100 mg/5mL
Ibuprofen is a ORAL SUSPENSION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Strides Pharma Science Limited. The primary component is IBUPROFEN.
MedlinePlus Drug Summary
Prescription ibuprofen is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints) and rheumatoid arthritis (arthritis caused by swelling of the lining of the joints). It is also used to relieve mild to moderate pain, including menstrual pain (pain that happens before or during a menstrual period). Nonprescription ibuprofen is used to reduce fever and to relieve minor aches and pain from headaches, muscle aches, arthritis, menstrual periods, the common cold, toothaches, and backaches. Ibuprofen 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: 64380-0997-03Last Updated: 04/28/2024
MedLinePlus Full Drug Details: Ibuprofen
Product Information
| NDC | 64380-0997 |
|---|---|
| Product ID | 64380-997_e6705907-f479-4472-b966-ba97929f927b |
| Associated GPIs | |
| GCN Sequence Number | 012080 |
| GCN Sequence Number Description | ibuprofen ORAL SUSP 100 MG/5ML ORAL |
| HIC3 | S2B |
| HIC3 Description | NSAIDS, CYCLOOXYGENASE INHIBITOR TYPE ANALGESICS |
| GCN | 35930 |
| HICL Sequence Number | 003723 |
| HICL Sequence Number Description | IBUPROFEN |
| Brand/Generic | Generic |
| Proprietary Name | Ibuprofen |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Ibuprofen |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SUSPENSION |
| Route | ORAL |
| Active Ingredient Strength | 100 |
| Active Ingredient Units | mg/5mL |
| Substance Name | IBUPROFEN |
| Labeler Name | Strides Pharma Science Limited |
| Pharmaceutical Class | Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA215311 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 64380-0997-03 (64380099703)
| NDC Package Code | 64380-997-03 |
|---|---|
| Billing NDC | 64380099703 |
| Package | 1 BOTTLE in 1 CARTON (64380-997-03) / 118 mL in 1 BOTTLE |
| Marketing Start Date | 2023-09-19 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |