Amlodipine Besylate and Benazepril Hydrochloride

Product NDC
70518-3030
11-digit product format
705183030
Labeler code
70518
Product ID
70518-3030_bc423600-b8c9-45fa-e053-2995a90a808c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine Besylate and Benazepril Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078466
Marketing category
ANDA
Marketing start
2021-02-25
Marketing end
0000-00-00
Substance
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Active strength
5 mg/1; mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-3030-02023-03-15C16284748780-1f386c64a-42c0-0266-e053-dadaa90a7c1abc42910a-67d9-4ad6-8801-d2d385559ab8
70518-3030-02023-01-30C16284748780-1f386c64a-42c0-0266-e053-dadaa90a7c1abc42910a-67d9-4ad6-8801-d2d385559ab8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3030-07051830300090 CAPSULE in 1 BOTTLE, PLASTIC (70518-3030-0) 90 capsule2021-02-250000-00-00NoNoCurrent