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Product NDC Code | 72189-231 | ||||||||||
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Drug Name | Ibuprofen |
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Type | Generic | ||||||||||
Pharm Class | Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC] |
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Active Ingredients |
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Route | ORAL | ||||||||||
Dosage Form | TABLET, FILM COATED | ||||||||||
RxCUI drug identifier | 197806, 197807 |
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Application Number | ANDA090796 | ||||||||||
Labeler Name | DIRECT RX | ||||||||||
Packages |
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Check if available Online | Get Medication Prices online with Discount |
Spl product data elements
Usually a list of ingredients in a drug product.IBUPROFEN IBUPROFEN CROSCARMELLOSE SODIUM POLYVINYL ALCOHOL, UNSPECIFIED TITANIUM DIOXIDE SILICON DIOXIDE TALC STARCH, CORN POLYETHYLENE GLYCOL, UNSPECIFIED IBUPROFEN IBUPROFEN MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE 123 IBUPROFEN IBUPROFEN CROSCARMELLOSE SODIUM MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL, UNSPECIFIED TALC TITANIUM DIOXIDE SILICON DIOXIDE IBUPROFEN IBUPROFEN STARCH, CORN POLYVINYL ALCOHOL, UNSPECIFIED 122
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.231
266
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67836482764
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72189-231-90
72189-231-60
72189-231-30
72189-266-15
Spl medguide
Information about the patient medication guide that accompanies the drug product. Certain drugs must be dispensed with an accompanying medication guide. This field may contain information about when to consult the medication guide and the contents of the medication guide.[MEDGUIDE IBUPROFEN TABLETS]
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.400mg (white to of white, round, biconvex, film coated tablets debossed with '121' on one side and plain on the other side) Bottles of 100 & 500
600mg (white to off white, capsule shaped, biconvex, film coated tablets debossed with '122' on one side and plain on the other side) Bottles of 30, 50, 100 & 500
800 mg (white to off-white, capsule shaped, biconvex, film-coated tablets debossed with ‘123’ on one side and plain on other side)
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API