Amlodipine and Benazepril Hydrochloride

Product NDC
50090-1039
11-digit product format
500901039
Labeler code
50090
Product ID
50090-1039_e55597f4-e80c-4025-a0ad-e8061ee09c78
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine and Benazepril Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA202239
Marketing category
ANDA
Marketing start
2012-09-05
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
50090-1039-02023-04-27C16284748780-1f386c649-c968-0266-e053-dadaa90a7c1a97b38387-ae7c-484a-af01-773bd8556b0d
50090-1039-02023-01-30C16284748780-1f386c649-c968-0266-e053-dadaa90a7c1a97b38387-ae7c-484a-af01-773bd8556b0d

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1039-0EA - Each50090-1039b58b5ed5-eb84-4db9-896f-63fdf213d04112018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1039AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS]22Legacy NDC20230429_97b38387-ae7c-484a-af01-773bd8556b0d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1039-05009010390030 CAPSULE in 1 BOTTLE (50090-1039-0) 30 capsule2014-11-280000-00-00NoNoCurrent