Delzicol

Product NDC
0023-5853
11-digit product format
000235853
Labeler code
0023
Product ID
0023-5853_bc74e71b-a05d-406b-b6fe-afb816500c1b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
mesalamine
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Allergan, Inc.
Application
NDA204412
Marketing category
NDA
Marketing start
2016-05-16
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
0023-5853-18EA - Each0023-58539112c505-6f6f-4a6e-9e22-c68c6ef361a712016-06-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0023-5853DELZICOL (MESALAMINE) CAPSULE, DELAYED RELEASE [ALLERGAN, INC.]21Legacy NDC20240906_71b02324-9430-4269-825f-8fcac5eeaefb.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0023-5853-1800023585318180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0023-5853-18) 2016-05-160000-00-00NoNoCurrent