MESALAMINE

Product NDC
70518-3239
11-digit product format
705183239
Labeler code
70518
Product ID
70518-3239_ceb58006-56ed-9ae2-e053-2a95a90a31f5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MESALAMINE
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
NDA204412
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2021-10-13
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
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-3239-02023-03-22C16284748780-1f386c649-b5fd-0266-e053-dadaa90a7c1ac2828b8f-1151-4b43-85a2-65db5f58a992
70518-3239-02023-01-30C16284748780-1f386c649-b5fd-0266-e053-dadaa90a7c1ac2828b8f-1151-4b43-85a2-65db5f58a992

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3239-07051832390030 POUCH in 1 BOX (70518-3239-0) > 1 CAPSULE, DELAYED RELEASE in 1 POUCH (70518-3239-1) 30 pouch2021-10-130000-00-00NoNoCurrent