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NDC 81522-0119-03 Ibuprofen 200 mg/1 Details
Ibuprofen 200 mg/1
Ibuprofen is a ORAL TABLET, COATED in the HUMAN OTC DRUG category. It is labeled and distributed by FSA STORE INC.. 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: 81522-0119-03Last Updated: 06/02/2024
MedLinePlus Full Drug Details: Ibuprofen
Product Information
| NDC | 81522-0119 |
|---|---|
| Product ID | 81522-119_faca7132-7c91-dfe4-e053-6294a90ac54d |
| 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 OTC DRUG |
| Dosage Form | TABLET, COATED |
| Route | ORAL |
| Active Ingredient Strength | 200 |
| Active Ingredient Units | mg/1 |
| Substance Name | IBUPROFEN |
| Labeler Name | FSA STORE INC. |
| 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 | ANDA079174 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 81522-0119-03 (81522011903)
| NDC Package Code | 81522-119-03 |
|---|---|
| Billing NDC | 81522011903 |
| Package | 1 BOTTLE, PLASTIC in 1 CARTON (81522-119-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC |
| Marketing Start Date | 2023-05-03 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |