AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE

Product NDC
49884-174
11-digit product format
498840174
Labeler code
49884
Product ID
49884-174_468724f1-bde7-4497-8028-915d44367e99
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amlodipine besylate valsartan hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Par Pharmaceutical, Inc.
Application
ANDA201087
Marketing category
ANDA
Marketing start
2015-06-01
Marketing end
2022-05-31
Substance
AMLODIPINE BESYLATE; VALSARTAN; HYDROCHLOROTHIAZIDE
Active strength
10 mg/1; 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],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49884-174-09EA - Each49884-1748e3a4f9b-c6d6-42fb-bb8f-5d9f002ecb6d12015-07-20
49884-174-11EA - Each49884-174ab4e0dbf-815a-46d8-84e9-c28994ddc9f212015-07-20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49884-174-0549884017405500 TABLET, FILM COATED in 1 BOTTLE (49884-174-05) 2015-06-010000-00-00NoNoCurrent
49884-174-094988401740990 TABLET, FILM COATED in 1 BOTTLE (49884-174-09) 2015-06-012022-05-31NoNoCurrent
49884-174-114988401741130 TABLET, FILM COATED in 1 BOTTLE (49884-174-11) 2015-06-012022-05-31NoNoCurrent