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NDC 71335-1396-01 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 Bryant Ranch Prepack. 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: 71335-1396-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Ibuprofen
Product Information
| NDC | 71335-1396 |
|---|---|
| Product ID | 71335-1396_840d6421-5e3e-4933-84fb-e5676439b9a0 |
| 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 | Bryant Ranch Prepack |
| 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 71335-1396-01 (71335139601)
| NDC Package Code | 71335-1396-1 |
|---|---|
| Billing NDC | 71335139601 |
| Package | 20 TABLET, FILM COATED in 1 BOTTLE (71335-1396-1) |
| Marketing Start Date | 2019-11-18 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 6d189e86-4c36-43f5-b406-a342458d4155 Details
HOW SUPPLIED
Product: 71335-1396
NDC: 71335-1396-0 84 TABLET, FILM COATED in a BOTTLE
NDC: 71335-1396-1 20 TABLET, FILM COATED in a BOTTLE
NDC: 71335-1396-2 15 TABLET, FILM COATED in a BOTTLE
NDC: 71335-1396-3 40 TABLET, FILM COATED in a BOTTLE
NDC: 71335-1396-4 21 TABLET, FILM COATED in a BOTTLE
NDC: 71335-1396-5 30 TABLET, FILM COATED in a BOTTLE
NDC: 71335-1396-6 90 TABLET, FILM COATED in a BOTTLE
NDC: 71335-1396-7 100 TABLET, FILM COATED in a BOTTLE
NDC: 71335-1396-8 120 TABLET, FILM COATED in a BOTTLE
NDC: 71335-1396-9 60 TABLET, FILM COATED in a BOTTLE
Product: 71335-1503
NDC: 71335-1503-0 21 TABLET, FILM COATED in a BOTTLE
NDC: 71335-1503-1 20 TABLET, FILM COATED in a BOTTLE
NDC: 71335-1503-2 15 TABLET, FILM COATED in a BOTTLE
NDC: 71335-1503-3 30 TABLET, FILM COATED in a BOTTLE
NDC: 71335-1503-4 40 TABLET, FILM COATED in a BOTTLE
NDC: 71335-1503-5 60 TABLET, FILM COATED in a BOTTLE
NDC: 71335-1503-6 90 TABLET, FILM COATED in a BOTTLE
NDC: 71335-1503-7 120 TABLET, FILM COATED in a BOTTLE
NDC: 71335-1503-8 50 TABLET, FILM COATED in a BOTTLE
NDC: 71335-1503-9 100 TABLET, FILM COATED in a BOTTLE
Product: 71335-1517
NDC: 71335-1517-1 20 TABLET, FILM COATED in a BOTTLE
NDC: 71335-1517-2 30 TABLET, FILM COATED in a BOTTLE
NDC: 71335-1517-3 40 TABLET, FILM COATED in a BOTTLE
NDC: 71335-1517-4 60 TABLET, FILM COATED in a BOTTLE
NDC: 71335-1517-5 90 TABLET, FILM COATED in a BOTTLE
NDC: 71335-1517-6 120 TABLET, FILM COATED in a BOTTLE
NDC: 71335-1517-7 100 TABLET, FILM COATED in a BOTTLE
NDC: 71335-1517-8 21 TABLET, FILM COATED in a BOTTLE
NDC: 71335-1517-9 15 TABLET, FILM COATED in a BOTTLE
INGREDIENTS AND APPEARANCE
| IBUPROFEN
ibuprofen tablet, film coated |
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| IBUPROFEN
ibuprofen tablet, film coated |
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| IBUPROFEN
ibuprofen tablet, film coated |
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| Labeler - Bryant Ranch Prepack (171714327) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Bryant Ranch Prepack | 171714327 | REPACK(71335-1517, 71335-1396, 71335-1503) , RELABEL(71335-1396, 71335-1503, 71335-1517) | |