NDC 50580-563

Motrin PM

Ibuprofen And Diphenhydramine Citrate

Motrin PM is a Oral Tablet, Coated 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; Diphenhydramine Citrate.

• Product ID: 50580-563_4059a624-b94f-40a5-ae59-181a589cafd2
• NDC: 50580-563
• Product Type: Human Otc Drug
• Proprietary Name: Motrin PM
• Generic Name: Ibuprofen And Diphenhydramine Citrate
• Dosage Form: Tablet, Coated
• Route of Administration: ORAL
• Marketing Start Date: 2010-01-11
• Marketing Category: ANDA / ANDA
• Application Number: ANDA079113
• Labeler Name: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
• Substance Name: IBUPROFEN; DIPHENHYDRAMINE CITRATE
• Active Ingredient Strength: 200 mg/1; mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 50580-563-20

1 BOTTLE, PLASTIC in 1 CARTON (50580-563-20) > 20 TABLET, COATED in 1 BOTTLE, PLASTIC

• Marketing Start Date: 2010-01-11
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50580-563-40 [50580056340]

Motrin PM TABLET, COATED

• Marketing Category: ANDA
• Application Number: ANDA079113
• Product Type: HUMAN OTC DRUG
• Billing Unit: EA
• Marketing Start Date: 2010-01-11
• Marketing End Date: 2019-01-31

NDC 50580-563-20 [50580056320]

Motrin PM TABLET, COATED

• Marketing Category: ANDA
• Application Number: ANDA079113
• Product Type: HUMAN OTC DRUG
• Billing Unit: EA
• Marketing Start Date: 2010-01-11

NDC 50580-563-80 [50580056380]

Motrin PM TABLET, COATED

• Marketing Category: ANDA
• Application Number: ANDA079113
• Product Type: HUMAN OTC DRUG
• Billing Unit: EA
• Marketing Start Date: 2010-01-11

Drug Details

Active Ingredients

Ingredient	Strength
IBUPROFEN	200 mg/1

OpenFDA Data

• SPL SET ID: 55403f19-58ae-450b-8a7b-0bc544088f20
• Manufacturer:
  • Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
• UNII:
  • WK2XYI10QM
  • 4OD433S209
• RxNorm Concept Unique ID - RxCUI:
  • 895664
  • 895666
• PHarm Class EPC:
  • Nonsteroidal Anti-inflammatory Drug [EPC]
• NUI Code:
  • N0000000160
  • N0000175722
  • N0000175721

NDC Crossover Matching brand name "Motrin PM" or generic name "Ibuprofen And Diphenhydramine Citrate"

NDC	Brand Name	Generic Name
66715-9733	Advil PM	Ibuprofen and Diphenhydramine citrate
55111-565	Ibuprofen and Diphenhydramine Citrate	Ibuprofen and Diphenhydramine Citrate
58602-867	Ibuprofen and Diphenhydramine Citrate	Ibuprofen and Diphenhydramine Citrate
50580-563	Motrin	Ibuprofen and Diphenhydramine Citrate