NDC 0485-0057

ED APAP

Acetaminophen

ED APAP is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Edwards Pharmaceuticals, Inc.. The primary component is Acetaminophen.

Product ID0485-0057_9d2f2fbf-0dd3-414f-9747-23dd7e7a7408
NDC0485-0057
Product TypeHuman Otc Drug
Proprietary NameED APAP
Generic NameAcetaminophen
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2012-03-07
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart343
Labeler NameEDWARDS PHARMACEUTICALS, INC.
Substance NameACETAMINOPHEN
Active Ingredient Strength160 mg/5mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0485-0057-08

236 mL in 1 BOTTLE, PLASTIC (0485-0057-08)
Marketing Start Date2012-03-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0485-0057-08 [00485005708]

ED APAP LIQUID
Marketing CategoryOTC monograph not final
Application Numberpart343
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2012-03-07
Inactivation Date2020-01-31
Reactivation Date2020-04-08

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN160 mg/5mL

OpenFDA Data

SPL SET ID:f76d5fff-ebea-40f9-aad3-4064a0c863f0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 307675
  • UPC Code
  • 0300485005782
  • NDC Crossover Matching brand name "ED APAP" or generic name "Acetaminophen"

    NDCBrand NameGeneric Name
    0485-0057ED APAPED APAP
    0121-0657AcetaminophenAcetaminophen
    0113-7000Basic Care acetaminophenAcetaminophen
    0113-7484basic care acetaminophenAcetaminophen
    0113-7544Basic Care AcetaminophenAcetaminophen
    0113-7130basic care childrens pain and feverAcetaminophen
    0113-0020good sense childrens pain and feverAcetaminophen
    0113-0212Good Sense Childrens Pain and FeverAcetaminophen
    0113-0608good sense childrens pain and feverAcetaminophen
    0113-0998Good Sense Childrens Pain and FeverAcetaminophen
    0113-0161Good Sense pain and feverAcetaminophen
    0113-0397Good Sense Pain and Feveracetaminophen
    0113-0590Good Sense Pain and Feveracetaminophen
    0113-0946good sense pain and feverAcetaminophen
    0113-8959Good Sense Pain and FeverAcetaminophen
    0113-0025Good Sense Pain ReliefAcetaminophen
    0113-0044Good Sense Pain ReliefAcetaminophen
    0113-0187good sense pain reliefAcetaminophen
    0113-0217good sense pain reliefAcetaminophen
    0113-0227Good Sense Pain ReliefAcetaminophen
    0113-0403good sense pain reliefAcetaminophen
    0113-0484Good Sense Pain ReliefAcetaminophen
    0113-0518good sense pain reliefAcetaminophen
    0113-0544good sense pain reliefAcetaminophen
    0113-1889good sense pain reliefacetaminophen
    0113-1975Good Sense Pain ReliefAcetaminophen
    0031-9301Robitussin Direct Sore Throat Painacetaminophen

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