NDC 49789-050

PROBUFEN

Ibuprofen

PROBUFEN is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Samsung Pharm Ind. Co., Ltd.. The primary component is Ibuprofen.

• Product ID: 49789-050_e9ad6a60-d765-4fa6-a155-b7e1e1bfc733
• NDC: 49789-050
• Product Type: Human Otc Drug
• Proprietary Name: PROBUFEN
• Generic Name: Ibuprofen
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2011-12-01
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part343
• Labeler Name: SAMSUNG PHARM IND. CO., LTD.
• Substance Name: IBUPROFEN
• Active Ingredient Strength: 400 mg/537mg
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 49789-050-01

537 mg in 1 BLISTER PACK (49789-050-01)

• Marketing Start Date: 2011-12-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 49789-050-01 [49789005001]

PROBUFEN TABLET

• Marketing Category: OTC monograph not final
• Application Number: part343
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2011-12-01
• Inactivation Date: 2019-11-13

Drug Details

Active Ingredients

Ingredient	Strength
IBUPROFEN	400 mg/537mg

OpenFDA Data

• SPL SET ID: 0fabf67c-5046-4272-b49c-17a3a0ba2fc7
• Manufacturer:
  • SAMSUNG PHARM IND. CO., LTD.
• UNII:
  • WK2XYI10QM
• RxNorm Concept Unique ID - RxCUI:
  • 197805
• PHarm Class EPC:
  • Nonsteroidal Anti-inflammatory Drug [EPC]
• NUI Code:
  • N0000000160
  • N0000175722
  • N0000175721

NDC Crossover Matching brand name "PROBUFEN" or generic name "Ibuprofen"

NDC	Brand Name	Generic Name
49789-050	PROBUFEN	PROBUFEN
0113-1461	basic care childrens ibuprofen	Ibuprofen
0113-7619	basic care childrens ibuprofen	ibuprofen
0113-7660	basic care childrens ibuprofen	Ibuprofen
0113-7897	Basic Care childrens ibuprofen	Ibuprofen
0113-0788	Basic Care ibuprofen	Ibuprofen
0113-7131	basic care ibuprofen	Ibuprofen
0113-7517	basic care ibuprofen	Ibuprofen
0113-7604	Basic Care Ibuprofen	Ibuprofen
0121-0917	Childrens Ibuprofen	Ibuprofen
0121-0914	Childrens Ibuprofen Oral Suspension	Ibuprofen
0113-2461	Good Sense Childrens Ibuprofen	Ibuprofen
0113-0057	Good Sense ibuprofen	ibuprofen
0113-0074	Good Sense ibuprofen	Ibuprofen
0113-0166	good sense ibuprofen	Ibuprofen
0113-0298	good sense ibuprofen	Ibuprofen
0113-0461	Good Sense ibuprofen	Ibuprofen
0113-0517	Good Sense ibuprofen	Ibuprofen
0113-0604	good sense ibuprofen	Ibuprofen
0113-0647	good sense ibuprofen	Ibuprofen
0113-0660	Good Sense Ibuprofen	Ibuprofen
0113-0685	Good Sense Ibuprofen	Ibuprofen
0113-0897	good sense ibuprofen	Ibuprofen
0113-1212	Good Sense Ibuprofen	Ibuprofen
0113-4501	good sense ibuprofen	ibuprofen
0113-0040	Good Sense Infants Ibuprofen	Ibuprofen