Mesalamine

Product NDC
42291-563
11-digit product format
422910563
Labeler code
42291
Product ID
42291-563_ec1947f9-5968-14be-e053-2995a90afa53
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mesalamine
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
AvKARE
Application
ANDA207873
Marketing category
ANDA
Marketing start
2019-08-26
Marketing end
0000-00-00
Substance
MESALAMINE
Active strength
400 mg/1
Pharmacologic classes
Aminosalicylate [EPC], Aminosalicylic Acids [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-563-18EA - Each42291-563df1d5fed-cdbe-495e-9e57-bb2cf778d2d412019-09-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42291-563-1842291056318180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (42291-563-18) 2019-08-260000-00-00NoNoCurrent