NDC 53041-634

Childrens Ibuprofen

Ibuprofen

Childrens Ibuprofen is a Oral Suspension/ Drops in the Human Otc Drug category. It is labeled and distributed by Guardian Drug Company. The primary component is Ibuprofen.

Product ID53041-634_510c1692-f23a-497b-8738-4b29e7c549e8
NDC53041-634
Product TypeHuman Otc Drug
Proprietary NameChildrens Ibuprofen
Generic NameIbuprofen
Dosage FormSuspension/ Drops
Route of AdministrationORAL
Marketing Start Date2018-08-21
Marketing CategoryANDA / ANDA
Application NumberANDA210149
Labeler NameGuardian Drug Company
Substance NameIBUPROFEN
Active Ingredient Strength100 mg/5mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 53041-634-03

1 BOTTLE in 1 CARTON (53041-634-03) > 120 mL in 1 BOTTLE
Marketing Start Date2018-08-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53041-634-03 [53041063403]

Childrens Ibuprofen SUSPENSION/ DROPS
Marketing CategoryANDA
Application NumberANDA210149
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-08-21

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN100 mg/5mL

OpenFDA Data

SPL SET ID:694866ce-c419-4b4c-bfb2-4175703d89f1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197803
  • PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
  • NUI Code
  • N0000000160
  • N0000175722
  • N0000175721
  • NDC Crossover Matching brand name "Childrens Ibuprofen" or generic name "Ibuprofen"

    NDCBrand NameGeneric Name
    0121-0917Childrens IbuprofenIbuprofen
    68016-255Childrens IbuprofenChildrens Ibuprofen
    68016-262Childrens IbuprofenChildrens Ibuprofen
    68016-250Childrens IbuprofenChildrens Ibuprofen
    68016-261Childrens IbuprofenChildrens Ibuprofen
    68016-263Childrens IbuprofenChildrens Ibuprofen
    68071-4217Childrens IbuprofenChildrens Ibuprofen
    68094-503Childrens IbuprofenChildrens Ibuprofen
    68094-494Childrens IbuprofenChildrens Ibuprofen
    0472-1255Childrens IbuprofenChildrens Ibuprofen
    0472-1263Childrens IbuprofenChildrens Ibuprofen
    0472-1261Childrens IbuprofenChildrens Ibuprofen
    68788-9109Childrens IbuprofenChildrens Ibuprofen
    69842-323Childrens IbuprofenChildrens Ibuprofen
    76413-344Childrens IbuprofenChildrens Ibuprofen
    11822-1261Childrens IbuprofenChildrens Ibuprofen
    11822-0166Childrens IbuprofenChildrens Ibuprofen
    0121-1836Childrens IbuprofenChildrens Ibuprofen
    37012-897Childrens IbuprofenChildrens Ibuprofen
    37012-166childrens ibuprofenchildrens ibuprofen
    37012-685Childrens IbuprofenChildrens Ibuprofen
    37808-200childrens ibuprofenchildrens ibuprofen
    41250-685childrens ibuprofenchildrens ibuprofen
    41250-419Childrens IbuprofenChildrens Ibuprofen
    41250-240childrens ibuprofenchildrens ibuprofen
    41250-626childrens ibuprofenchildrens ibuprofen
    45802-133Childrens IbuprofenChildrens Ibuprofen
    45802-140Childrens IbuprofenChildrens Ibuprofen
    49035-126Childrens IbuprofenChildrens Ibuprofen
    50090-2528Childrens IbuprofenChildrens Ibuprofen
    50090-3227CHILDRENS IBUPROFENCHILDRENS IBUPROFEN
    53041-634Childrens IbuprofenChildrens Ibuprofen
    55154-1585Childrens IbuprofenChildrens Ibuprofen
    55154-1577Childrens IbuprofenChildrens Ibuprofen
    55312-685childrens ibuprofenchildrens ibuprofen
    55319-150Childrens IbuprofenChildrens Ibuprofen
    55319-263Childrens IbuprofenChildrens Ibuprofen
    58602-200CHILDRENS IBUPROFENCHILDRENS IBUPROFEN
    58602-212CHILDRENS IBUPROFENCHILDRENS IBUPROFEN
    59779-882Childrens IbuprofenChildrens Ibuprofen
    59779-971Childrens IbuprofenChildrens Ibuprofen
    0363-1262Childrens IbuprofenChildrens Ibuprofen
    0363-1263Childrens IbuprofenChildrens Ibuprofen
    0363-1255Childrens IbuprofenChildrens Ibuprofen
    0363-1761Childrens IbuprofenChildrens Ibuprofen
    0363-1261Childrens IbuprofenChildrens Ibuprofen
    0363-1763Childrens IbuprofenChildrens Ibuprofen
    0363-1764Childrens IbuprofenChildrens Ibuprofen
    0363-1762Childrens IbuprofenChildrens Ibuprofen
    0363-7610Childrens IbuprofenChildrens Ibuprofen

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