NDC 54257-573

Acetaminophen Extended-Release

Acetaminophen

Acetaminophen Extended-Release is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Magno-humphries, Inc.. The primary component is Acetaminophen.

Product ID54257-573_9d47b3b4-a0d6-76c4-e053-2995a90a2eed
NDC54257-573
Product TypeHuman Otc Drug
Proprietary NameAcetaminophen Extended-Release
Generic NameAcetaminophen
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2020-01-24
Marketing CategoryANDA / ANDA
Application NumberANDA211544
Labeler NameMagno-Humphries, Inc.
Substance NameACETAMINOPHEN
Active Ingredient Strength650 mg/1
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 54257-573-03

200 TABLET in 1 BOTTLE (54257-573-03)
Marketing Start Date2020-01-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54257-573-03 [54257057303]

Acetaminophen Extended-Release TABLET
Marketing CategoryANDA
Application NumberANDA211544
Product TypeHUMAN OTC DRUG
Marketing Start Date2020-01-24

NDC 54257-573-02 [54257057302]

Acetaminophen Extended-Release TABLET
Marketing CategoryANDA
Application NumberANDA211544
Product TypeHUMAN OTC DRUG
Marketing Start Date2020-01-24
Marketing End Date2020-01-29

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN650 mg/1

NDC Crossover Matching brand name "Acetaminophen Extended-Release" or generic name "Acetaminophen"

NDCBrand NameGeneric Name
54257-573Acetaminophen Extended-ReleaseAcetaminophen Extended-Release
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.