FDA.reportPublic FDA data

Amlodipine Besylate

Product NDC
68180-455
11-digit product format
681800455
Labeler code
68180
Product ID
68180-455_cc27c9a5-dd2e-4a79-af00-28f51408362a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine Besylate
Dosage form
TABLET
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA078043
Marketing category
ANDA
Marketing start
2024-06-12
Substance
AMLODIPINE BESYLATE
Active strength
5 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], 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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMLODIPINE BESYLATE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii864V2Q084H
Rxcui197361, 308135, 308136

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
1f1c6e4b-bbad-4649-afd1-7a1d671db4b1Product name120150316
63ab5fbf-2a6b-c41d-051a-39e845d718b1Product name120140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68180-455-01Amlodipine Besylate90 in 1 BOTTLETABLET9029
68180-455-02Amlodipine Besylate1000 in 1 BOTTLETABLET100029

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-455-01EA - Each68180-4556c7e071a-c60e-40ba-b805-aa553d2b1b2f12024-05-16
68180-455-02EA - Each68180-45553dc53f1-e267-4953-a423-ff3eafe9fbeb12024-05-16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HAMLODIPINE BESYLATE TABLET [LUPIN PHARMACEUTICALS, INC.]9
AMLODIPINEACTIVE MOIETY1J444QC288AMLODIPINE BESYLATE TABLET [LUPIN PHARMACEUTICALS, INC.]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMLODIPINE BESYLATE TABLET [LUPIN PHARMACEUTICALS, INC.]9
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPAMLODIPINE BESYLATE TABLET [LUPIN PHARMACEUTICALS, INC.]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMLODIPINE BESYLATE TABLET [LUPIN PHARMACEUTICALS, INC.]9
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMLODIPINE BESYLATE TABLET [LUPIN PHARMACEUTICALS, INC.]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-455AMLODIPINE BESYLATE TABLET [LUPIN PHARMACEUTICALS, INC.]26Current NDC, 2 package rows20250508_003dd1ec-16f8-4f96-b6a8-c4689d35892a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308135amLODIPine besylate 10 MG Oral TabletPSN003dd1ec-16f8-4f96-b6a8-c4689d35892a29
308136amLODIPine besylate 2.5 MG Oral TabletPSN003dd1ec-16f8-4f96-b6a8-c4689d35892a29
197361amLODIPine besylate 5 MG Oral TabletPSN003dd1ec-16f8-4f96-b6a8-c4689d35892a29
308135amlodipine 10 MG Oral TabletSCD003dd1ec-16f8-4f96-b6a8-c4689d35892a29
308136amlodipine 2.5 MG Oral TabletSCD003dd1ec-16f8-4f96-b6a8-c4689d35892a29
197361amlodipine 5 MG Oral TabletSCD003dd1ec-16f8-4f96-b6a8-c4689d35892a29
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSY003dd1ec-16f8-4f96-b6a8-c4689d35892a29
308136amlodipine (as amlodipine besylate) 2.5 MG Oral TabletSY003dd1ec-16f8-4f96-b6a8-c4689d35892a29
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSY003dd1ec-16f8-4f96-b6a8-c4689d35892a29

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68180-455-016818004550190 TABLET in 1 BOTTLE (68180-455-01) 90 tablet2024-06-24NoNoCurrent
68180-455-02681800455021000 TABLET in 1 BOTTLE (68180-455-02) 1000 tablet2024-06-12NoNoCurrent