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NDC 60760-0604-00 IBUPROFEN 800 mg/1 Details
IBUPROFEN 800 mg/1
IBUPROFEN is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by St. Mary's Medical Park Pharmacy. 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: 60760-0604-00Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Ibuprofen
Product Information
| NDC | 60760-0604 |
|---|---|
| Product ID | 60760-604_a9f31e25-9560-5012-e053-2a95a90a52c0 |
| Associated GPIs | 66100020000340 |
| GCN Sequence Number | 008350 |
| GCN Sequence Number Description | ibuprofen TABLET 800 MG ORAL |
| HIC3 | S2B |
| HIC3 Description | NSAIDS, CYCLOOXYGENASE INHIBITOR TYPE ANALGESICS |
| GCN | 35744 |
| 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 | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 800 |
| Active Ingredient Units | mg/1 |
| Substance Name | IBUPROFEN |
| Labeler Name | St. Mary's Medical Park Pharmacy |
| 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 60760-0604-00 (60760060400)
| NDC Package Code | 60760-604-00 |
|---|---|
| Billing NDC | 60760060400 |
| Package | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-604-00) |
| Marketing Start Date | 2020-04-14 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 950c3ca7-4481-976f-e053-2995a90ad51e Details
SPL UNCLASSIFIED SECTION
800 mg (white to off-white, capsule shaped, biconvex, film-coated tablets debossed with ‘123’ on one side and plain on other side)
Supplied as:
NDC 60760-604-09 BOTTLES OF 9
NDC 60760-604-20 BOTTLES OF 20
NDC 60760-604-30 BOTTLES OF 30
NDC 60760-604-60 BOTTLES OF 60
NDC 60760-604-90 BOTTLES OF 90
NDC 60760-604-00 BOTTLES OF 100
INGREDIENTS AND APPEARANCE
| IBUPROFEN
ibuprofen tablet, film coated |
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| Labeler - St. Mary's Medical Park Pharmacy (063050751) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| St. Mary's Medical Park Pharmacy | 063050751 | relabel(60760-604) , repack(60760-604) | |