NDC 68094-503

Childrens Ibuprofen

Ibuprofen

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

Product ID68094-503_1440ed00-59c2-49da-8a67-67694ca1a641
NDC68094-503
Product TypeHuman Otc Drug
Proprietary NameChildrens Ibuprofen
Generic NameIbuprofen
Dosage FormSuspension
Route of AdministrationORAL
Marketing Start Date2006-09-14
Marketing CategoryANDA / ANDA
Application NumberANDA074937
Labeler NamePrecision Dose Inc.
Substance NameIBUPROFEN
Active Ingredient Strength100 mg/5mL
Pharm ClassesAnti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2024-12-31

Packaging

NDC 68094-503-61

10 TRAY in 1 CASE (68094-503-61) > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE (68094-503-59)
Marketing Start Date2006-09-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68094-503-62 [68094050362]

Childrens Ibuprofen SUSPENSION
Marketing CategoryANDA
Application NumberANDA074937
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2006-09-14

NDC 68094-503-59 [68094050359]

Childrens Ibuprofen SUSPENSION
Marketing CategoryANDA
Application NumberANDA074937
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2006-09-14

NDC 68094-503-61 [68094050361]

Childrens Ibuprofen SUSPENSION
Marketing CategoryANDA
Application NumberANDA074937
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2006-09-14

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN200 mg/10mL

OpenFDA Data

SPL SET ID:1984374e-7639-4a4f-bf96-a614e663e0c4
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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