NDC 65162-672

Ibuprofen Pain Reliever/ Fever Reducer

Ibuprofen

Ibuprofen Pain Reliever/ Fever Reducer is a Oral Suspension in the Human Otc Drug category. It is labeled and distributed by Amneal Pharmaceuticals. The primary component is Ibuprofen.

• Product ID: 65162-672_010ab916-bc42-4e69-85d6-6585fc34226d
• NDC: 65162-672
• Product Type: Human Otc Drug
• Proprietary Name: Ibuprofen Pain Reliever/ Fever Reducer
• Generic Name: Ibuprofen
• Dosage Form: Suspension
• Route of Administration: ORAL
• Marketing Start Date: 2011-11-12
• Marketing Category: ANDA / ANDA
• Application Number: ANDA200457
• Labeler Name: Amneal Pharmaceuticals
• Substance Name: IBUPROFEN
• Active Ingredient Strength: 100 mg/5mL
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 65162-672-86

1 BOTTLE in 1 CARTON (65162-672-86) > 118 mL in 1 BOTTLE

• Marketing Start Date: 2011-11-12
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 65162-672-86 [65162067286]

Ibuprofen Pain Reliever/ Fever Reducer SUSPENSION

• Marketing Category: ANDA
• Application Number: ANDA200457
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2011-11-12
• Inactivation Date: 2019-11-13

Drug Details

Active Ingredients

Ingredient	Strength
IBUPROFEN	100 mg/5mL

OpenFDA Data

• SPL SET ID: ae1cb9ae-9d01-47f0-b9ec-0d924d913514
• Manufacturer:
  • Amneal Pharmaceuticals
• UNII:
  • WK2XYI10QM
• RxNorm Concept Unique ID - RxCUI:
  • 197803
• PHarm Class EPC:
  • Nonsteroidal Anti-inflammatory Drug [EPC]
• NUI Code:
  • N0000000160
  • N0000175722
  • N0000175721

NDC Crossover Matching brand name "Ibuprofen Pain Reliever/ Fever Reducer" or generic name "Ibuprofen"

NDC	Brand Name	Generic Name
68016-030	Ibuprofen Pain reliever/ Fever Reducer	Ibuprofen Pain reliever/ Fever Reducer
65162-672	Ibuprofen Pain Reliever/ Fever Reducer	Ibuprofen Pain Reliever/ Fever Reducer
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