MedPath

IBUPROFEN

IBUPROFEN 400 MG - 600 MG AND 800 MG TABLETS

Approved
Approval ID

9dfc752f-3f66-4c39-bfa8-db6de9a9a9bf

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 3, 2024

Manufacturers
FDA

REMEDYREPACK INC.

DUNS: 829572556

Products 1

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

IBUPROFEN

PRODUCT DETAILS

NDC Product Code70518-0005
Application NumberANDA090796
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 3, 2024
Generic NameIBUPROFEN

INGREDIENTS (10)

MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
IBUPROFENActive
Quantity: 800 mg in 1 1
Code: WK2XYI10QM
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 12/11/2024

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

HOW SUPPLIED SECTION

LOINC: 34069-5Updated: 12/11/2024

Ibuprofen tablets are available in the following strength:

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

“Preserve in well-closed containers”

Store at 20 ° to 25°C (68°to 77°F) [See USP Controlled Room Temperature].

Rx only

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

SPL MEDGUIDE SECTION

LOINC: 42231-1Updated: 12/11/2024

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=876704)

Repackaged By / Distributed By: RemedyRepack Inc.

625 Kolter Drive, Indiana, PA 15701

(724) 465-8762

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

IBUPROFEN - FDA Drug Approval Details