Benazepril Hydrochloride

Product NDC
21695-326
11-digit product format
216950326
Labeler code
21695
Product ID
21695-326_56ffd662-60a6-4b43-a7ea-f778714dfbbd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benazepril Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rebel Distributors Corp.
Application
ANDA076402
Marketing category
ANDA
Marketing start
2004-02-11
Marketing end
0000-00-00
Substance
D&C YELLOW NO. 10
Active strength
10 mg/1
Pharmacologic classes
Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-326-30Benazepril Hydrochloride30 in 1 BOTTLETABLET, FILM COATED301
21695-326-60Benazepril Hydrochloride60 in 1 BOTTLETABLET, FILM COATED601
21695-326-90Benazepril Hydrochloride90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-326-30EA - Each21695-32661dff4db-9e07-408f-913f-181b63ace43d12012-07-24
21695-326-60EA - Each21695-326b6a2183b-9ad5-44bc-9262-c4d0db21f8c312012-07-24
21695-326-90EA - Each21695-326f9dc2d08-4a9a-4804-b6ef-1cf8419c0bb112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
benazepril hydrochlorideACTIVE INGREDIENTN1SN99T69TBENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
D&C YELLOW NO. 10ACTIVE INGREDIENT35SW5USQ3GBENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
benazeprilACTIVE MOIETYUDM7Q7QWP8BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
colloidal silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
crospovidoneINACTIVE INGREDIENT68401960MKBENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GBENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOABENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYBENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
hypromelloseINACTIVE INGREDIENT3NXW29V3WOBENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XBENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
polyethylene glycolINACTIVE INGREDIENT3WJQ0SDW1ABENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHBENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPBENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
zinc stearateINACTIVE INGREDIENTH92E6QA4FVBENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-326BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1Legacy NDC, 3 package rows20100921_56ffd662-60a6-4b43-a7ea-f778714dfbbd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898690benazepril HCl 20 MG Oral TabletPSN56ffd662-60a6-4b43-a7ea-f778714dfbbd1
898719benazepril HCl 40 MG Oral TabletPSN56ffd662-60a6-4b43-a7ea-f778714dfbbd1
898723benazepril HCl 5 MG Oral TabletPSN56ffd662-60a6-4b43-a7ea-f778714dfbbd1
898690benazepril hydrochloride 20 MG Oral TabletSCD56ffd662-60a6-4b43-a7ea-f778714dfbbd1
898719benazepril hydrochloride 40 MG Oral TabletSCD56ffd662-60a6-4b43-a7ea-f778714dfbbd1
898723benazepril hydrochloride 5 MG Oral TabletSCD56ffd662-60a6-4b43-a7ea-f778714dfbbd1
898723benazepril HCl 5 MG Oral TabletSY56ffd662-60a6-4b43-a7ea-f778714dfbbd1
898690BZP hydrochloride 20 MG Oral TabletSY56ffd662-60a6-4b43-a7ea-f778714dfbbd1
898719BZP hydrochloride 40 MG Oral TabletSY56ffd662-60a6-4b43-a7ea-f778714dfbbd1
898723BZP hydrochloride 5 MG Oral TabletSY56ffd662-60a6-4b43-a7ea-f778714dfbbd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-326-302169503263030 in 1 BOTTLEHistorical
21695-326-602169503266060 in 1 BOTTLEHistorical
21695-326-902169503269090 in 1 BOTTLEHistorical