isosorbide mononitrate

Product NDC
63629-1424
11-digit product format
636291424
Labeler code
63629
Product ID
63629-1424_5df2009d-23f3-47ea-8fa6-343f25ad75f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
isosorbide mononitrate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075155
Marketing category
ANDA
Marketing start
1998-10-30
Marketing end
0000-00-00
Substance
ISOSORBIDE MONONITRATE
Active strength
30 mg/1
Pharmacologic classes
Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1424-1EA - Each63629-1424451cc30b-63d3-48f4-90fd-b7a151ca410312013-02-13
63629-1424-2EA - Each63629-14245ee6a484-2ca1-476f-9dee-e0fc3006e6ca12013-02-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-1424-16362914240130 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-1424-1) 2021-11-300000-00-00NoNoCurrent
63629-1424-26362914240290 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-1424-2) 2021-11-300000-00-00NoNoCurrent
63629-1424-36362914240360 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-1424-3) 2021-11-300000-00-00NoNoCurrent
63629-1424-463629142404120 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-1424-4) 2021-11-300000-00-00NoNoCurrent
63629-1424-56362914240510 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-1424-5) 2021-11-300000-00-00NoNoCurrent