Amlodipine Besylate and Benazepril Hydrochloride

Product NDC
70518-3303
11-digit product format
705183303
Labeler code
70518
Product ID
70518-3303_d3c0e88a-a8eb-9f05-e053-2a95a90a8f82
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
2021-12-22
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
70518-3303-02023-03-24C16284748780-1f386c64a-2caa-0266-e053-dadaa90a7c1af824b96b-ea60-4f46-bf55-373a0b921a46
70518-3303-02023-01-30C16284748780-1f386c64a-2caa-0266-e053-dadaa90a7c1af824b96b-ea60-4f46-bf55-373a0b921a46

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3303-07051833030028 CAPSULE in 1 BLISTER PACK (70518-3303-0) 28 capsule2021-12-220000-00-00NoNoCurrent