FDA.reportPublic FDA data

Amlodipine Besylate and Benazepril Hydrochloride

Product NDC
50090-5357
11-digit product format
500905357
Labeler code
50090
Product ID
50090-5357_2257a49f-9ed5-4f2a-b543-9946f3570f0b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine Besylate and Benazepril Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078466
Marketing category
ANDA
Marketing start
2018-10-04
Substance
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Active strength
5; 40 mg/1; mg/1
Pharmacologic classes
Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Decreased Blood Pressure [PE], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Amlodipine Besylate and Benazepril Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMLODIPINE BESYLATE5 mg/1
BENAZEPRIL HYDROCHLORIDE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii864V2Q084H, N1SN99T69T
Rxcui898359

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fa898d56-9495-d6f0-309b-68a5d8e3914aProduct name420260305
c19ec24d-2c40-4b8d-7c20-500ffa3660a1Product name320260303
b15e9aa6-d523-ca97-480e-570e0543a342Product name420251024
265792b3-b999-c010-7364-a7db20b9d4d9Product name520250515
14c2c15b-f823-4ada-a40e-a440544294dcProduct name120221207
a72887ef-d675-499f-af4b-78688f6855cdProduct name120191002
a4484670-2869-6416-f6ff-03b1b3cbd1b0Product name220190415
4a27501f-a987-48a5-99b4-e983d4744d76Product name720181211
18600d07-613d-bf9c-2711-fe40c06f3393Product name520180703
bded1554-44de-900a-5297-403365d6d4b2Product name320170110
55bffd21-17e1-ff02-2e8f-1f9a532b9502Product name220150320
1f1c6e4b-bbad-4649-afd1-7a1d671db4b1Product name120150316
63ab5fbf-2a6b-c41d-051a-39e845d718b1Product name120140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212Product name120140508
b9fbc696-7d55-c52e-4f12-7e3d99cd2db4Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5357-02023-02-07C16284748780-1f386c64a-41f7-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULES. AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE capsules, for oral use. Initial U.S. Approval: 1995
50090-5357-02023-01-30C16284748780-1f386c64a-41f7-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULES. AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE capsules, for oral use. Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5357-0Amlodipine Besylate and Benazepril Hydrochloride90 in 1 BOTTLECAPSULE906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5357AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS]4Current NDC, Legacy NDC, 1 package rows20230919_c695f95d-6064-4a22-84ba-c8e62477b3a7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898359amLODIPine besylate 5 MG / benazepril HCl 40 MG Oral CapsulePSNc695f95d-6064-4a22-84ba-c8e62477b3a76
898359amlodipine 5 MG / benazepril hydrochloride 40 MG Oral CapsuleSCDc695f95d-6064-4a22-84ba-c8e62477b3a76
898359amlodipine (as amlodipine besylate) 5 MG / benazepril hydrochloride 40 MG Oral CapsuleSYc695f95d-6064-4a22-84ba-c8e62477b3a76
898359Amlodipine 5 MG / BZP hydrochloride 40 MG Oral CapsuleSYc695f95d-6064-4a22-84ba-c8e62477b3a76

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5357-05009053570090 CAPSULE in 1 BOTTLE (50090-5357-0) 90 capsule2020-11-120000-00-00NoNoCurrent