Amlodipine and Valsartan

Product NDC
49884-575
11-digit product format
498840575
Labeler code
49884
Product ID
49884-575_da9d6b5f-b731-4c4a-b259-d5a2ca11b220
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amlodipine and valsartan
Dosage form
TABLET
Route
ORAL
Labeler
Par Pharmaceutical, Inc.
Application
ANDA090011
Marketing category
ANDA
Marketing start
2014-09-30
Marketing end
0000-00-00
Substance
AMLODIPINE; VALSARTAN
Active strength
10 mg/1; mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49884-575-11EA - Each49884-5754225d19c-92a0-4945-88ac-b4e77b100a9312014-10-03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49884-575-094988405750990 TABLET in 1 BOTTLE, PLASTIC (49884-575-09) 90 tablet2014-09-300000-00-00NoNoCurrent
49884-575-114988405751130 TABLET in 1 BOTTLE, PLASTIC (49884-575-11) 30 tablet2014-09-300000-00-00NoNoCurrent