FDA.reportPublic FDA data

Amlobenz

Product NDC
21695-916
11-digit product format
216950916
Labeler code
21695
Product ID
21695-916_43464a6b-a3b8-445b-b020-cf60f0b5e8a4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlobenz
Dosage form
CAPSULE
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA077183
Marketing category
ANDA
Marketing start
2010-04-19
Marketing end
0000-00-00
Substance
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Active strength
10 mg/1; mg/1
Pharmacologic classes
Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
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
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
21695-916-302019-09-24C16284748780-1934fe258-4a82-48b1-e053-8cdaa90a720aThese highlights do not include all the information needed to use amlodipine besylate and benazepril hydrochloride capsules safely and effectively. See full prescribing information for amlodipine besylate and benazepril hydrochloride capsules. Amlodipine Besylate and Benazepril Hydrochloride Capsules Initial U.S. Approval: 1995
21695-916-902019-09-24C16284748780-1934fe258-4a82-48b1-e053-8cdaa90a720aThese highlights do not include all the information needed to use amlodipine besylate and benazepril hydrochloride capsules safely and effectively. See full prescribing information for amlodipine besylate and benazepril hydrochloride capsules. Amlodipine Besylate and Benazepril Hydrochloride Capsules Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-916-30Amlobenz30 in 1 BOTTLECAPSULE301
21695-916-90Amlobenz90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-916-30EA - Each21695-916b7a4e028-7602-45e2-8f78-5e921ad9e80412012-07-24
21695-916-90EA - Each21695-916d2b67c28-3c04-4312-9de0-af5dcd576c8112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HAMLOBENZ CAPSULE [REBEL DISTRIBUTORS CORP]1
BENAZEPRIL HYDROCHLORIDEACTIVE INGREDIENTN1SN99T69TAMLOBENZ CAPSULE [REBEL DISTRIBUTORS CORP]1
AMLODIPINEACTIVE MOIETY1J444QC288AMLOBENZ CAPSULE [REBEL DISTRIBUTORS CORP]1
BENAZEPRILACTIVE MOIETYUDM7Q7QWP8AMLOBENZ CAPSULE [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMLOBENZ CAPSULE [REBEL DISTRIBUTORS CORP]1
colloidal silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4AMLOBENZ CAPSULE [REBEL DISTRIBUTORS CORP]1
crospovidoneINACTIVE INGREDIENT68401960MKAMLOBENZ CAPSULE [REBEL DISTRIBUTORS CORP]1
FERRIC OXIDE BLACKINACTIVE INGREDIENTXM0M87F357AMLOBENZ CAPSULE [REBEL DISTRIBUTORS CORP]1
gelatinINACTIVE INGREDIENT2G86QN327LAMLOBENZ CAPSULE [REBEL DISTRIBUTORS CORP]1
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYAMLOBENZ CAPSULE [REBEL DISTRIBUTORS CORP]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XAMLOBENZ CAPSULE [REBEL DISTRIBUTORS CORP]1
magnesium stearateINACTIVE INGREDIENT70097M6I30AMLOBENZ CAPSULE [REBEL DISTRIBUTORS CORP]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMLOBENZ CAPSULE [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAMLOBENZ CAPSULE [REBEL DISTRIBUTORS CORP]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPAMLOBENZ CAPSULE [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-916AMLOBENZ CAPSULE [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20110722_43464a6b-a3b8-445b-b020-cf60f0b5e8a4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898342amLODIPine besylate 10 MG / benazepril HCl 20 MG Oral CapsulePSN43464a6b-a3b8-445b-b020-cf60f0b5e8a41
898342amlodipine 10 MG / benazepril hydrochloride 20 MG Oral CapsuleSCD43464a6b-a3b8-445b-b020-cf60f0b5e8a41
898342amlodipine (as amlodipine besylate) 10 MG / benazepril hydrochloride 20 MG Oral CapsuleSY43464a6b-a3b8-445b-b020-cf60f0b5e8a41
898342Amlodipine 10 MG / BZP hydrochloride 20 MG Oral CapsuleSY43464a6b-a3b8-445b-b020-cf60f0b5e8a41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-916-302169509163030 in 1 BOTTLEHistorical
21695-916-902169509169090 in 1 BOTTLEHistorical