Amlodipine Besylate

Product NDC
63739-631
11-digit product format
637390631
Labeler code
63739
Product ID
63739-631_b34a85d6-01aa-e3eb-e053-2995a90ac6bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine Besylate
Dosage form
TABLET
Route
ORAL
Labeler
McKesson Corporation dba SKY Packaging
Application
ANDA078226
Marketing category
ANDA
Marketing start
2007-09-21
Marketing end
2021-07-31
Substance
AMLODIPINE BESYLATE
Active strength
10 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63739-631-102020-07-22C16284748780-1ab0e2407-2911-f274-e053-dbdaa90a6471e062d365-fda8-4c9e-b4b8-3d273153c50c

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63739-631-10EA - Each63739-63101733867-6497-4c26-8a49-4966687ce61a12014-10-03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63739-631-106373906311010 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-631-10) > 10 TABLET in 1 BLISTER PACK10 blister pack2014-09-042021-07-31NoNoCurrent