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

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70518-0005
Application NumberANDA090796
Product Classification
M
Marketing Category
C73584
G
Generic Name
IBUPROFEN
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 3, 2024
FDA Product Classification

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