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NDC 49483-0604-01 IBUPROFEN 800 mg/1 Details

IBUPROFEN 800 mg/1

IBUPROFEN is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by TIME CAP LABORATORIES, 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: 49483-0604-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Ibuprofen

Product Information

NDC	49483-0604
Product ID	49483-604_9af0c38e-0340-926c-e053-2995a90a30c8
Associated GPIs	66100020000340
GCN Sequence Number	008350
GCN Sequence Number Description	ibuprofen TABLET 800 MG ORAL
HIC3	S2B
HIC3 Description	NSAIDS, CYCLOOXYGENASE INHIBITOR TYPE ANALGESICS
GCN	35744
HICL Sequence Number	003723
HICL Sequence Number Description	IBUPROFEN
Brand/Generic	Generic
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	800
Active Ingredient Units	mg/1
Substance Name	IBUPROFEN
Labeler Name	TIME CAP LABORATORIES, 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	2024-12-31

Package

Package Images

NDC 49483-0604-01 (49483060401)

Pricing Information
NDC Package Code	49483-604-01
Billing NDC	49483060401
Package	100 TABLET, FILM COATED in 1 BOTTLE (49483-604-01)
Marketing Start Date	2015-12-30
NDC Exclude Flag	N
Price Per Unit	0.0657
Pricing Unit	EA
Effective Date	2024-02-21
NDC Description	IBUPROFEN 800 MG TABLET
Pharmacy Type Indicator	C/I
OTC	N
Explanation Code	1
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL ec3e8443-d742-4c25-8516-f0df4ebfccdc Details

ibuprofen tablets 400 mg - 600 mg- 800 mg medguide

HOW SUPPLIED

400mg (white to of white, round, biconvex, film coated tablets debossed with '121' on one side and plain on the other side) Bottles of 100 & 500

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 30, 50, 100 & 500

SPL UNCLASSIFIED SECTION

800 mg (white to off-white, capsule shaped, biconvex, film-coated tablets debossed with ‘123’ on one side and plain on other side)

400mg Ibuprofen 100 count label

400 mg 500 count label

600 mg 100 count label

800 mg 100 count label

600 MG 500 COUNT LABEL

800 MG 500 COUNT LABEL

INGREDIENTS AND APPEARANCE

IBUPROFEN

ibuprofen tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:49483-602
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	400 mg

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

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	13mm
Flavor		Imprint Code	121
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:49483-602-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	12/30/2015
2	NDC:49483-602-50	500 in 1 BOTTLE; Type 0: Not a Combination Product	12/30/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA090796	12/30/2015

IBUPROFEN

ibuprofen tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	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)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL (UNII: 532B59J990)
STARCH, PREGELATINIZED 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:49483-603-03	30 in 1 BOTTLE; Type 0: Not a Combination Product	12/30/2015
2	NDC:49483-603-05	50 in 1 BOTTLE; Type 0: Not a Combination Product	12/30/2015
3	NDC:49483-603-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	12/30/2015
4	NDC:49483-603-50	500 in 1 BOTTLE; Type 0: Not a Combination Product	12/30/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA090796	12/30/2015

IBUPROFEN

ibuprofen tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:49483-604
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)	IBUPROFEN	800 mg

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

Product Characteristics
Color	white	Score	no score
Shape	CAPSULE	Size	19mm
Flavor		Imprint Code	123
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:49483-604-03	30 in 1 BOTTLE; Type 0: Not a Combination Product	12/30/2015
2	NDC:49483-604-05	50 in 1 BOTTLE; Type 0: Not a Combination Product	12/30/2015
3	NDC:49483-604-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	12/30/2015
4	NDC:49483-604-50	500 in 1 BOTTLE; Type 0: Not a Combination Product	12/30/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA090796	12/30/2015

Labeler - TIME CAP LABORATORIES, INC (037052099)

Registrant - TIME CAP LABORATORIES, INC (037052099)

Name	Address	ID/FEI	Business Operations
Establishment
MARKSANS PHARMA LIMITED		925822975	manufacture(49483-602, 49483-603, 49483-604)

Revised: 12/2019

Document Id: 9af0c38e-0340-926c-e053-2995a90a30c8

Set id: ec3e8443-d742-4c25-8516-f0df4ebfccdc

Version: 7

Effective Time: 20191230

Search by Drug Name or NDC

NDC 49483-0604-01 IBUPROFEN 800 mg/1 Details

IBUPROFEN 800 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 49483-0604-01 (49483060401)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL ec3e8443-d742-4c25-8516-f0df4ebfccdc Details

ibuprofen tablets 400 mg - 600 mg- 800 mg medguide

HOW SUPPLIED

HOW SUPPLIED

SPL UNCLASSIFIED SECTION

400mg Ibuprofen 100 count label

400 mg 500 count label

600 mg 100 count label

800 mg 100 count label

600 MG 500 COUNT LABEL

800 MG 500 COUNT LABEL

INGREDIENTS AND APPEARANCE

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