NDC 55319-263

Childrens Ibuprofen

Ibuprofen

Childrens Ibuprofen is a Oral Suspension in the Human Otc Drug category. It is labeled and distributed by Family Dollar Services Inc.. The primary component is Ibuprofen.

Product ID55319-263_84348dd8-cae2-4ff5-b24d-0a9f463c45c0
NDC55319-263
Product TypeHuman Otc Drug
Proprietary NameChildrens Ibuprofen
Generic NameIbuprofen
Dosage FormSuspension
Route of AdministrationORAL
Marketing Start Date2012-02-23
Marketing End Date2020-03-31
Marketing CategoryANDA / ANDA
Application NumberANDA074916
Labeler NameFamily Dollar Services Inc.
Substance NameIBUPROFEN
Active Ingredient Strength100 mg/5mL
NDC Exclude FlagN

Packaging

NDC 55319-263-94

1 BOTTLE in 1 CARTON (55319-263-94) > 118 mL in 1 BOTTLE
Marketing Start Date2012-02-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55319-263-94 [55319026394]

Childrens Ibuprofen SUSPENSION
Marketing CategoryANDA
Application NumberANDA074916
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-02-23
Marketing End Date2020-03-31

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN100 mg/5mL

OpenFDA Data

SPL SET ID:e24c517b-c61f-40a7-b817-dcfaab22e09f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197803
  • PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
  • UPC Code
  • 0032251025822
  • NUI Code
  • N0000000160
  • N0000175722
  • N0000175721