NDC 50580-603

Childrens Motrin

Ibuprofen

Childrens Motrin is a Oral Suspension in the Human Otc Drug category. It is labeled and distributed by Johnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division. The primary component is Ibuprofen.

• Product ID: 50580-603_30a3a571-f371-4779-9e2c-a17cfbe6d63b
• NDC: 50580-603
• Product Type: Human Otc Drug
• Proprietary Name: Childrens Motrin
• Generic Name: Ibuprofen
• Dosage Form: Suspension
• Route of Administration: ORAL
• Marketing Start Date: 2016-01-25
• Marketing Category: NDA / NDA
• Application Number: NDA020516
• Labeler Name: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
• Substance Name: IBUPROFEN
• Active Ingredient Strength: 100 mg/5mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 50580-603-04

1 BOTTLE in 1 CARTON (50580-603-04) > 120 mL in 1 BOTTLE

• Marketing Start Date: 2016-01-25
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50580-603-01 [50580060301]

Childrens Motrin SUSPENSION

• Marketing Category: NDA
• Application Number: NDA020516
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-01-25
• Marketing End Date: 2015-12-14

NDC 50580-603-04 [50580060304]

Childrens Motrin SUSPENSION

• Marketing Category: NDA
• Application Number: NDA020516
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2016-01-25

Drug Details

Active Ingredients

Ingredient	Strength
IBUPROFEN	100 mg/5mL

OpenFDA Data

• SPL SET ID: 4f664479-f68c-464a-956d-25bb9f39c4cc
• Manufacturer:
  • Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
• UNII:
  • WK2XYI10QM
• RxNorm Concept Unique ID - RxCUI:
  • 544393
  • 197803
• PHarm Class EPC:
  • Nonsteroidal Anti-inflammatory Drug [EPC]
• NUI Code:
  • N0000000160
  • N0000175722
  • N0000175721

NDC Crossover Matching brand name "Childrens Motrin" or generic name "Ibuprofen"

NDC	Brand Name	Generic Name
50580-601	Childrens MOTRIN	Childrens MOTRIN
50580-604	Childrens Motrin	Childrens Motrin
50580-603	Childrens Motrin	Childrens Motrin
50580-184	Childrens Motrin	Childrens Motrin
50580-932	Childrens Motrin	Childrens Motrin
50580-933	Childrens Motrin	Childrens Motrin
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