NDC 53041-263

Loperamide Hydrochloride, Simethicone

Loperamide Hydrochloride, Simethicone

Loperamide Hydrochloride, Simethicone is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Guardian Drug Company. The primary component is Loperamide Hydrochloride; Dimethicone.

Product ID53041-263_289e6064-8eb8-4b56-bc9e-ee82ad83674f
NDC53041-263
Product TypeHuman Otc Drug
Proprietary NameLoperamide Hydrochloride, Simethicone
Generic NameLoperamide Hydrochloride, Simethicone
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2021-06-01
Marketing CategoryANDA /
Application NumberANDA214541
Labeler NameGuardian Drug Company
Substance NameLOPERAMIDE HYDROCHLORIDE; DIMETHICONE
Active Ingredient Strength2 mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 53041-263-50

1 BLISTER PACK in 1 CARTON (53041-263-50) > 6 TABLET in 1 BLISTER PACK
Marketing Start Date2021-06-01
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Loperamide Hydrochloride, Simethicone" or generic name "Loperamide Hydrochloride, Simethicone"

NDCBrand NameGeneric Name
53041-263Loperamide Hydrochloride, SimethiconeLoperamide Hydrochloride, Simethicone
0363-1830anti diarrheal and anti gasloperamide hydrochloride, simethicone
11822-1003anti diarrheal anti gasloperamide hydrochloride, simethicone
30142-581Anti Diarrheal Anti GasLoperamide Hydrochloride, Simethicone
37808-714anti diarrheal anti gasloperamide hydrochloride, simethicone
46122-566Anti Diarrheal Anti Gasloperamide hydrochloride, simethicone
41250-375anti diarrheal plus anti gasloperamide hydrochloride, simethicone
56062-511antidiarrheal multi symptom reliefloperamide hydrochloride, simethicone
0113-7119basic care loperamide hydrochloride and simethiconeloperamide hydrochloride, simethicone
41520-772CareOne Diarrhea and Gas Controlloperamide hydrochloride, simethicone
55910-383dg health anti diarrheal anti gasloperamide hydrochloride, simethicone
41163-553equaline anti diarrheal plus anti gasloperamide hydrochloride, simethicone
49035-549equate anti diarrheal anti gasloperamide hydrochloride, simethicone
55319-823family wellness anti diarrheal plus anti gasloperamide hydrochloride, simethicone
55319-106family wellness anti diarrheal plus multi symptom reliefloperamide hydrochloride, simethicone
46122-620good neighbor pharmacy anti diarrheal anti gasloperamide hydrochloride, simethicone
0113-0087good sense anti diarrheal anti gasloperamide hydrochloride, simethicone
0113-1087Good Sense Anti Diarrheal Anti Gasloperamide hydrochloride, simethicone
62011-0365health mart anti diarrheal anti gasloperamide hydrochloride, simethicone
21130-183signature care anti diarrheal anti gasloperamide hydrochloride, simethicone
36800-633topcare anti diarrheal anti gasloperamide hydrochloride, simethicone
11673-646up and up anti diarrheal anti gasloperamide hydrochloride, simethicone

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