NDC 61245-085

Direct Safety Ibuprofen

Ibuprofen

Direct Safety Ibuprofen is a Oral Tablet, Coated in the Human Otc Drug category. It is labeled and distributed by Conney Safety Products, Llc. The primary component is Ibuprofen.

Product ID61245-085_4a150730-2b8f-6492-e054-00144ff88e88
NDC61245-085
Product TypeHuman Otc Drug
Proprietary NameDirect Safety Ibuprofen
Generic NameIbuprofen
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2016-02-01
Marketing CategoryANDA / ANDA
Application NumberANDA075010
Labeler NameConney Safety Products, LLC
Substance NameIBUPROFEN
Active Ingredient Strength200 mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 61245-085-13

250 PACKET in 1 BOX (61245-085-13) > 2 TABLET, COATED in 1 PACKET
Marketing Start Date2016-02-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61245-085-13 [61245008513]

Direct Safety Ibuprofen TABLET, COATED
Marketing CategoryANDA
Application NumberANDA075010
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-02-01

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN200 mg/1

OpenFDA Data

SPL SET ID:28d45743-d298-29db-e054-00144ff8d46c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310965
  • PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
  • NUI Code
  • N0000000160
  • N0000175722
  • N0000175721
  • NDC Crossover Matching brand name "Direct Safety Ibuprofen" or generic name "Ibuprofen"

    NDCBrand NameGeneric Name
    61245-085Direct Safety IbuprofenDirect Safety Ibuprofen
    61245-082Direct Safety IbuprofenDirect Safety Ibuprofen
    61245-084Direct Safety IbuprofenDirect Safety Ibuprofen
    0113-1461basic care childrens ibuprofenIbuprofen
    0113-7619basic care childrens ibuprofenibuprofen
    0113-7660basic care childrens ibuprofenIbuprofen
    0113-7897Basic Care childrens ibuprofenIbuprofen
    0113-0788Basic Care ibuprofenIbuprofen
    0113-7131basic care ibuprofenIbuprofen
    0113-7517basic care ibuprofenIbuprofen
    0113-7604Basic Care IbuprofenIbuprofen
    0121-0917Childrens IbuprofenIbuprofen
    0121-0914Childrens Ibuprofen Oral SuspensionIbuprofen
    0113-2461Good Sense Childrens IbuprofenIbuprofen
    0113-0057Good Sense ibuprofenibuprofen
    0113-0074Good Sense ibuprofenIbuprofen
    0113-0166good sense ibuprofenIbuprofen
    0113-0298good sense ibuprofenIbuprofen
    0113-0461Good Sense ibuprofenIbuprofen
    0113-0517Good Sense ibuprofenIbuprofen
    0113-0604good sense ibuprofenIbuprofen
    0113-0647good sense ibuprofenIbuprofen
    0113-0660Good Sense IbuprofenIbuprofen
    0113-0685Good Sense IbuprofenIbuprofen
    0113-0897good sense ibuprofenIbuprofen
    0113-1212Good Sense IbuprofenIbuprofen
    0113-4501good sense ibuprofenibuprofen
    0113-0040Good Sense Infants IbuprofenIbuprofen

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