IBUPROFEN
- Ibuprofen IBUPROFEN 800 mg/1 NCS HealthCare of KY, Inc dba Vangard Labs
- IBUPROFEN IBUPROFEN 800 mg/1 TIME CAP LABORATORIES, INC
- IBUPROFEN IBUPROFEN 800 mg/1 St. Mary's Medical Park Pharmacy
- Ibuprofen IBUPROFEN 800 mg/1 NuCare Pharmaceuticals,Inc.
- Ibuprofen IBUPROFEN 800 mg/1 Strides Pharma Inc.
- Ibuprofen IBUPROFEN 800 mg/1 Advanced Rx Pharmacy of Tennessee, LLC
- IBUPROFEN IBUPROFEN 800 mg/1 Direct_Rx
- Ibuprofen IBUPROFEN 800 mg/1 PD-Rx Pharmaceuticals, Inc.
- Ibuprofen IBUPROFEN 800 mg/1 Preferred Pharmaceuticals Inc.
- Ibuprofen IBUPROFEN 800 mg/1 Ascend Laboratories, LLC
- Ibuprofen IBUPROFEN 800 mg/1 REMEDYREPACK INC.
- IBUPROFEN IBUPROFEN 800 mg/1 Direct_Rx
- Ibuprofen IBUPROFEN 800 mg/1 PD-Rx Pharmaceuticals, Inc.
- Ibuprofen IBUPROFEN 800 mg/1 Chartwell RX, LLC
- Ibuprofen IBUPROFEN 800 mg/1 NuCare Pharmaceuticals,Inc.
- IBUPROFEN IBUPROFEN 800 mg/1 NuCare Pharmaceuticals,Inc.
- IBUPROFEN IBUPROFEN 800 mg/1 REMEDYREPACK INC.
- IBUPROFEN IBUPROFEN 800 mg/1 PD-Rx Pharmaceuticals, Inc.
- Ibuprofen IBUPROFEN 800 mg/1 PD-Rx Pharmaceuticals, Inc.
- Ibuprofen IBUPROFEN 800 mg/1 PD-Rx Pharmaceuticals, Inc.
- Ibuprofen IBUPROFEN 800 mg/1 Northwind Pharmaceuticals
- Ibuprofen IBUPROFEN 800 mg/1 A-S Medication Solutions
- Ibuprofen and famotidine FAMOTIDINE 26.6 mg/1 Ascend Laboratories, LLC
- Ibuprofen IBUPROFEN 800 mg/1 Proficient Rx LP
- Ibuprofen IBUPROFEN 800 mg/1 PharmPak, Inc.
- Ibuprofen IBUPROFEN 800 mg/1 Northwind Pharmaceuticals
- Ibuprofen IBUPROFEN 800 mg/1 PD-Rx Pharmaceuticals, Inc.
- Ibuprofen IBUPROFEN 800 mg/1 A-S Medication Solutions
- IBUPROFEN IBUPROFEN 800 mg/1 Direct_Rx
- Ibuprofen IBUPROFEN 800 mg/1 Preferred Pharmaceuticals Inc.
- IBUPROFEN IBUPROFEN 800 mg/1 PD-Rx Pharmaceuticals, Inc.
- Ibuprofen and famotidine FAMOTIDINE 26.6 mg/1 Bryant Ranch Prepack
- Ibuprofen IBUPROFEN 800 mg/1 EXELAN PHARMACEUTICALS, INC.
- Ibuprofen IBUPROFEN 800 mg/1 Preferred Pharmaceuticals Inc.
- IBUPROFEN IBUPROFEN 800 mg/1 UNIT DOSE SERVICES
- Ibuprofen IBUPROFEN 800 mg/1 A-S Medication Solutions
- Ibuprofen IBUPROFEN 800 mg/1 Amneal Pharmaceuticals NY LLC
- Ibuprofen IBUPROFEN 800 mg/1 Advanced Rx Pharmacy of Tennessee, LLC
- IBUPROFEN IBUPROFEN 800 mg/1 DIRECT RX
- IBUPROFEN IBUPROFEN 800 mg/1 RPK Pharmaceuticals, Inc.
- IBUPROFEN IBUPROFEN 800 mg/1 DIRECTRX
- Ibuprofen IBUPROFEN 800 mg/1 A-S Medication Solutions
- Ibuprofen IBUPROFEN 800 mg/1 PD-Rx Pharmaceuticals, Inc.
- Ibuprofen IBUPROFEN 800 mg/1 A-S Medication Solutions
- Ibuprofen and famotidine FAMOTIDINE 26.6 mg/1 Doc Rx
- Ibuprofen and famotidine FAMOTIDINE 26.6 mg/1 Bryant Ranch Prepack
- Ibuprofen IBUPROFEN 800 mg/1 NuCare Pharmaceuticals,Inc.
- Ibuprofen IBUPROFEN 800 mg/1 Granules India Limited
- Ibuprofen IBUPROFEN 800 mg/1 Granules India Limited
- Ibuprofen IBUPROFEN 800 mg/1 Quality Care Products LLC
- IBUPROFEN IBUPROFEN 800 mg/1 medsource pharmaceuticals
- IBUPROFEN IBUPROFEN 800 mg/1 NuCare Pharmaceuticals,Inc.
- IBUPROFEN IBUPROFEN 800 mg/1 DIRECT RX
- Ibuprofen IBUPROFEN 800 mg/1 Strides Pharma Science Limited
- Ibuprofen IBUPROFEN 800 mg/1 Cardinal Health 107, LLC
- IBUPROFEN IBUPROFEN 800 mg/1 Northwind Pharmaceuticals
- Ibuprofen IBUPROFEN 800 mg/1 Bryant Ranch Prepack
- Ibuprofen IBUPROFEN 800 mg/1 PD-Rx Pharmaceuticals, Inc.
- Ibuprofen IBUPROFEN 800 mg/1 REMEDYREPACK INC.
- Ibuprofen IBUPROFEN 800 mg/1 A-S Medication Solutions
Summary of product characteristics
Effective Time
20230327
Version
13
Spl Product Data Elements
IBUPROFEN IBUPROFEN SILICON DIOXIDE CROSCARMELLOSE SODIUM MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL STARCH, PREGELATINIZED CORN TALC TITANIUM DIOXIDE IBUPROFEN IBUPROFEN 123
Application Number
ANDA090796
Brand Name
IBUPROFEN
Generic Name
IBUPROFEN
Product Ndc
70518-0005
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Package Label Principal Display Panel
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
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
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
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