ZALDYON

Product NDC
70710-1543
11-digit product format
707101543
Labeler code
70710
Product ID
70710-1543_eb752411-d484-43d2-af87-48be5af649e7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
mesalamine
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA203286
Marketing category
ANDA
Marketing start
2019-01-17
Marketing end
0000-00-00
Substance
MESALAMINE
Active strength
800 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 Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1543ZALDYON (MESALAMINE) TABLET, DELAYED RELEASE [ZYDUS PHARMACEUTICALS USA INC.]7Legacy NDC20230812_89eb4706-c347-4bb8-8f89-394dbdec5cd3.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70710-1543-47071015430410 BLISTER PACK in 1 CARTON (70710-1543-4) > 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK (70710-1543-2) 10 blister pack2019-01-170000-00-00NoNoCurrent
70710-1543-870710154308180 TABLET, DELAYED RELEASE in 1 BOTTLE (70710-1543-8) 2019-01-170000-00-00NoNoCurrent