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| Product NDC Code | 70518-0005 | ||||
|---|---|---|---|---|---|
| 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 | 197807 | ||||
| Application Number | ANDA090796 | ||||
| Labeler Name | REMEDYREPACK INC. | ||||
| 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 SILICON DIOXIDE CROSCARMELLOSE SODIUM MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL STARCH, PREGELATINIZED CORN TALC TITANIUM DIOXIDE IBUPROFEN IBUPROFEN 123
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.PRINCIPAL DISPLAY PANEL DRUG: IBUPROFEN GENERIC: IBUPROFEN DOSAGE: TABLET, FILM COATED ADMINSTRATION: ORAL NDC: 70518-0005-0 NDC: 70518-0005-1 NDC: 70518-0005-2 NDC: 70518-0005-3 NDC: 70518-0005-4 NDC: 70518-0005-5 NDC: 70518-0005-6 COLOR: white SHAPE: CAPSULE SCORE: No score SIZE: 19 mm IMPRINT: 123 PACKAGING: 21 in 1 BLISTER PACK PACKAGING: 14 in 1 BLISTER PACK PACKAGING: 30 in 1 BLISTER PACK PACKAGING: 10 in 1 BLISTER PACK PACKAGING: 90 in 1 BOTTLE PLASTIC PACKAGING: 30 in 1 BOTTLE PLASTIC PACKAGING: 30 in 1 BLISTER PACK ACTIVE INGREDIENT(S): IBUPROFEN 800mg in 1 INACTIVE INGREDIENT(S): SILICON DIOXIDE CROSCARMELLOSE SODIUM MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL STARCH, PREGELATINIZED CORN TALC TITANIUM DIOXIDE MM7
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.1. ibuprofen tablets 400 mg - 600 mg- 800 mg medguide Repackaged By / Distributed By: RemedyRepack Inc. 625 Kolter Drive, Indiana, PA 15701 (724) 465-8762
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.800 mg (white to off-white, capsule shaped, biconvex, film-coated tablets debossed with ‘123’ on one side and plain on other side) NDC: 70518-0005-00 NDC: 70518-0005-01 NDC: 70518-0005-02 NDC: 70518-0005-03 NDC: 70518-0005-04 NDC: 70518-0005-05 NDC: 70518-0005-06 PACKAGING: 21 in 1 BLISTER PACK PACKAGING: 14 in 1 BLISTER PACK PACKAGING: 30 in 1 BLISTER PACK PACKAGING: 10 in 1 BLISTER PACK PACKAGING: 90 in 1 BOTTLE PLASTIC PACKAGING: 30 in 1 BOTTLE PLASTIC PACKAGING: 30 in 1 BLISTER PACK Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
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