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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
unfinished packagepackage54127-095054127-0950-0UNFINISHEDActive or certified unfinished drug listing2026-10-16

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 dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2019-06-01 22:24 UTC · source 2019-05-30unfinished packagepackage54127-095054127-0950-0UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip5b2001dcd8f5…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
IngredientStrength
MESALAMINE1 kg/kg

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startStatus
54127-0950-05412709500049 kg in 1 DRUM (54127-0950-0)49 kg29-APR-96Current