NDC 65162-356

Ibuprofen Pain Reliever/Fever Reducer

Ibuprofen

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

• Product ID: 65162-356_312d6d3b-a143-4850-90d5-ad6c677545ac
• NDC: 65162-356
• Product Type: Human Otc Drug
• Proprietary Name: Ibuprofen Pain Reliever/Fever Reducer
• Generic Name: Ibuprofen
• Dosage Form: Capsule, Liquid Filled
• Route of Administration: ORAL
• Marketing Start Date: 2013-03-29
• Marketing Category: ANDA / ANDA
• Application Number: ANDA202300
• Labeler Name: Amneal Pharmaceuticals LLC
• Substance Name: IBUPROFEN
• Active Ingredient Strength: 200 mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 65162-356-02

1 BOTTLE in 1 CARTON (65162-356-02) > 20 CAPSULE, LIQUID FILLED in 1 BOTTLE

• Marketing Start Date: 2013-03-29
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 65162-356-50 [65162035650]

Ibuprofen Pain Reliever/Fever Reducer CAPSULE, LIQUID FILLED

• Marketing Category: ANDA
• Application Number: ANDA202300
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2013-03-29

NDC 65162-356-11 [65162035611]

Ibuprofen Pain Reliever/Fever Reducer CAPSULE, LIQUID FILLED

• Marketing Category: ANDA
• Application Number: ANDA202300
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2013-03-29

NDC 65162-356-02 [65162035602]

Ibuprofen Pain Reliever/Fever Reducer CAPSULE, LIQUID FILLED

• Marketing Category: ANDA
• Application Number: ANDA202300
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2013-03-29

NDC 65162-356-69 [65162035669]

Ibuprofen Pain Reliever/Fever Reducer CAPSULE, LIQUID FILLED

• Marketing Category: ANDA
• Application Number: ANDA202300
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2013-03-29

Drug Details

Active Ingredients

Ingredient	Strength
IBUPROFEN	200 mg/1

OpenFDA Data

• SPL SET ID: 877440fc-3afb-4123-a2e6-5cb48c74413c
• Manufacturer:
  • Amneal Pharmaceuticals LLC
• UNII:
  • WK2XYI10QM
• RxNorm Concept Unique ID - RxCUI:
  • 310964
• 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
69168-338	Ibuprofen Pain reliever/fever reducer	Ibuprofen Pain reliever/fever reducer
65162-770	Ibuprofen Pain Reliever/Fever Reducer	Ibuprofen Pain Reliever/Fever Reducer
65162-356	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