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NDC 68788-7602-01 IBUPROFEN 600 mg/1 Details

IBUPROFEN 600 mg/1

IBUPROFEN is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Preferred Pharmaceuticals Inc.. The primary component is IBUPROFEN.

MedlinePlus Drug Summary

Prescription ibuprofen is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints) and rheumatoid arthritis (arthritis caused by swelling of the lining of the joints). It is also used to relieve mild to moderate pain, including menstrual pain (pain that happens before or during a menstrual period). Nonprescription ibuprofen is used to reduce fever and to relieve minor aches and pain from headaches, muscle aches, arthritis, menstrual periods, the common cold, toothaches, and backaches. Ibuprofen is in a class of medications called NSAIDs. It works by stopping the body's production of a substance that causes pain, fever, and inflammation.

Related Packages: 68788-7602-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Ibuprofen

Product Information

NDC	68788-7602
Product ID	68788-7602_d3dafad2-3676-4293-811a-65033a116a2d
Associated GPIs	66100020000330
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	IBUPROFEN
Proprietary Name Suffix	n/a
Non-Proprietary Name	IBUPROFEN
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	600
Active Ingredient Units	mg/1
Substance Name	IBUPROFEN
Labeler Name	Preferred Pharmaceuticals Inc.
Pharmaceutical Class	Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA090796
Listing Certified Through	2023-12-31

Package

Package Images

NDC 68788-7602-01 (68788760201)

Pricing Information	N/A
NDC Package Code	68788-7602-1
Billing NDC	68788760201
Package	100 TABLET, FILM COATED in 1 BOTTLE (68788-7602-1)
Marketing Start Date	2020-02-14
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL bd7d9986-f0ec-4013-8b57-6ce7cc013cf6 Details

ibuprofen tablets 400 mg - 600 mg- 800 mg medguide

Repackaged By: Preferred Pharmaceuticals Inc.

HOW SUPPLIED

600mg (white to off white, capsule shaped, biconvex, film coated tablets debossed with '122' on one side and plain on the other side)

: Bottles of 14 NDC 68788-7602-4

Repackaged By: Preferred Pharmaceuticals Inc.

600mg Label

INGREDIENTS AND APPEARANCE

IBUPROFEN

ibuprofen tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:68788-7602(NDC:49483-603)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	600 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score	no score
Shape	CAPSULE	Size	18mm
Flavor		Imprint Code	122
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:68788-7602-4	14 in 1 BOTTLE; Type 0: Not a Combination Product	02/14/2020
2	NDC:68788-7602-2	20 in 1 BOTTLE; Type 0: Not a Combination Product	02/14/2020
3	NDC:68788-7602-7	21 in 1 BOTTLE; Type 0: Not a Combination Product	02/14/2020
4	NDC:68788-7602-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	02/14/2020
5	NDC:68788-7602-5	50 in 1 BOTTLE; Type 0: Not a Combination Product	02/14/2020
6	NDC:68788-7602-6	60 in 1 BOTTLE; Type 0: Not a Combination Product	02/14/2020
7	NDC:68788-7602-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	02/14/2020
8	NDC:68788-7602-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	02/14/2020
9	NDC:68788-7602-8	120 in 1 BOTTLE; Type 0: Not a Combination Product	02/14/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA090796	02/14/2020

Labeler - Preferred Pharmaceuticals Inc. (791119022)

Registrant - Preferred Pharmaceuticals Inc. (791119022)

Name	Address	ID/FEI	Business Operations
Establishment
Preferred Pharmaceuticals Inc.		791119022	REPACK(68788-7602)

Revised: 7/2022

Document Id: d3dafad2-3676-4293-811a-65033a116a2d

Set id: bd7d9986-f0ec-4013-8b57-6ce7cc013cf6

Version: 3

Effective Time: 20220707