Home NDC 54127-0950-0 54127-0950-0
Product NDC 54127-0950
Requested package NDC 54127-0950-0
11-digit product format 541270950
Labeler code 54127
Product ID 54127-0950_255e605a-7faa-4f35-9626-8b2b697f4ad1
Type BULK INGREDIENT
Nonproprietary name MESALAMINE
Dosage form POWDER
Marketing category BULK INGREDIENT
Marketing start 1996-04-29
Substance MESALAMINE
Active strength 1 kg/kg
Listing certified through 2027-12-31
Current FDA listing Yes
Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2019-06-01 22:24 UTC · source 2019-05-30 unfinished package package 54127-0950 54127-0950-0 UNFINISHED Active or certified unfinished drug listing unfinished / ndc_unfinished.zip 5b2001dcd8f5…54b53d4dc9e4…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product No
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MESALAMINE 1 kg/kg
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Status 54127-0950-0 54127095000 49 kg in 1 DRUM (54127-0950-0) 49 kg 29-APR-96 Current