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FDA Approval

IBUPROFEN

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
REMEDYREPACK INC.
DUNS: 829572556
Effective Date
March 15, 2024
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Ibuprofen(600 mg in 1 1)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

IBUPROFEN

Product Details

NDC Product Code
70518-3313
Application Number
ANDA090796
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
March 15, 2024
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
IbuprofenActive
Code: WK2XYI10QMClass: ACTIBQuantity: 600 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990Class: IACT

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

DRUG: IBUPROFEN

GENERIC: IBUPROFEN

DOSAGE: TABLET, FILM COATED

ADMINSTRATION: ORAL

NDC: 70518-3313-0

COLOR: white

SHAPE: CAPSULE

SCORE: No score

SIZE: 18 mm

IMPRINT: 122

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • IBUPROFEN 600mg in 1

INACTIVE INGREDIENT(S):

  • SILICON DIOXIDE
  • CROSCARMELLOSE SODIUM
  • MAGNESIUM STEARATE
  • CELLULOSE, MICROCRYSTALLINE
  • POLYETHYLENE GLYCOL, UNSPECIFIED
  • POLYVINYL ALCOHOL
  • STARCH, PREGELATINIZED CORN
  • TALC
  • TITANIUM DIOXIDE

MM1

SPL MEDGUIDE SECTION

ibuprofen tablets 400 mg - 600 mg- 800 mg medguide

![MEDGUIDE IBUPROFEN TABLETS](/dailymed/image.cfm?name=Medication+Guide+for+Nonsteroidal+Anti- inflammatory+drugs.jpg&id=776196)

Repackaged By / Distributed By: RemedyRepack Inc.

625 Kolter Drive, Indiana, PA 15701

(724) 465-8762

HOW SUPPLIED SECTION

600 mg (white to off-white, capsule shaped, biconvex, film-coated​ tablets debossed with ‘122’ on one side and plain on other side)

NDC: 70518-3313-00

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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