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NDC 45865-0117-20 IBUPROFEN 600 mg/1 Details
IBUPROFEN 600 mg/1
IBUPROFEN is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Medsource Pharmaceuticals. 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: 45865-0117-20Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Ibuprofen
Product Information
| NDC | 45865-0117 |
|---|---|
| Product ID | 45865-117_b42e36f4-ff24-0b5a-e053-2a95a90ac629 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | IBUPROFEN |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | IBUPROFEN |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 600 |
| Active Ingredient Units | mg/1 |
| Substance Name | IBUPROFEN |
| Labeler Name | Medsource Pharmaceuticals |
| 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 | ANDA090796 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 45865-0117-20 (45865011720)
| NDC Package Code | 45865-117-20 |
|---|---|
| Billing NDC | 45865011720 |
| Package | 20 TABLET, FILM COATED in 1 BOTTLE (45865-117-20) |
| Marketing Start Date | 2020-07-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL b42e35f1-0624-2f95-e053-2995a90a52b8 Details
HOW SUPPLIED
INGREDIENTS AND APPEARANCE
| IBUPROFEN
ibuprofen tablet, film coated |
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| Labeler - Medsource Pharmaceuticals (833685915) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Medsource Pharmaceuticals | 833685915 | repack(45865-117) | |