FDA.reportPublic FDA data

Benazepril hydrochloride

Product NDC
62135-721
11-digit product format
621350721
Labeler code
62135
Product ID
62135-721_24246e61-c66b-9c3e-e063-6294a90a5207
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benazepril hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA076267
Marketing category
ANDA
Marketing start
2022-08-20
Substance
BENAZEPRIL HYDROCHLORIDE
Active strength
20 mg/1
Pharmacologic classes
Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Decreased Blood Pressure [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Benazepril hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENAZEPRIL HYDROCHLORIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN1SN99T69T
Rxcui898687, 898690, 898719, 898723

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a4484670-2869-6416-f6ff-03b1b3cbd1b0Product name220190415
55bffd21-17e1-ff02-2e8f-1f9a532b9502Product name220150320
b9fbc696-7d55-c52e-4f12-7e3d99cd2db4Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62135-721-90Benazepril hydrochloride90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-721-90EA - Each62135-721d9b19cc0-002e-4e8d-bbd8-297a501835b812023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-721BENAZEPRIL HYDROCHLORIDE TABLET [CHARTWELL RX, LLC]2Current NDC, 1 package rows20241012_df13d8d8-0d70-4d6f-9dd1-5da38fbe2562.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898687benazepril HCl 10 MG Oral TabletPSNdf13d8d8-0d70-4d6f-9dd1-5da38fbe25622
898690benazepril HCl 20 MG Oral TabletPSNdf13d8d8-0d70-4d6f-9dd1-5da38fbe25622
898719benazepril HCl 40 MG Oral TabletPSNdf13d8d8-0d70-4d6f-9dd1-5da38fbe25622
898723benazepril HCl 5 MG Oral TabletPSNdf13d8d8-0d70-4d6f-9dd1-5da38fbe25622
898687benazepril hydrochloride 10 MG Oral TabletSCDdf13d8d8-0d70-4d6f-9dd1-5da38fbe25622
898690benazepril hydrochloride 20 MG Oral TabletSCDdf13d8d8-0d70-4d6f-9dd1-5da38fbe25622
898719benazepril hydrochloride 40 MG Oral TabletSCDdf13d8d8-0d70-4d6f-9dd1-5da38fbe25622
898723benazepril hydrochloride 5 MG Oral TabletSCDdf13d8d8-0d70-4d6f-9dd1-5da38fbe25622
898723benazepril HCl 5 MG Oral TabletSYdf13d8d8-0d70-4d6f-9dd1-5da38fbe25622
898687BZP hydrochloride 10 MG Oral TabletSYdf13d8d8-0d70-4d6f-9dd1-5da38fbe25622
898690BZP hydrochloride 20 MG Oral TabletSYdf13d8d8-0d70-4d6f-9dd1-5da38fbe25622
898719BZP hydrochloride 40 MG Oral TabletSYdf13d8d8-0d70-4d6f-9dd1-5da38fbe25622
898723BZP hydrochloride 5 MG Oral TabletSYdf13d8d8-0d70-4d6f-9dd1-5da38fbe25622

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-721-906213507219090 TABLET in 1 BOTTLE (62135-721-90) 90 tablet2023-07-20NoNoHistorical