FDA.reportPublic FDA data

Amlodipine Besylate

Product NDC
57664-056
11-digit product format
576640056
Labeler code
57664
Product ID
57664-056_8858588a-91db-42f1-89fe-9a70b1bc369d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMLODIPINE BESYLATE
Dosage form
TABLET
Route
ORAL
Labeler
Caraco Pharmaceutical Laboratories, Ltd.
Application
ANDA078552
Marketing category
ANDA
Marketing start
2012-10-19
Marketing end
0000-00-00
Substance
AMLODIPINE BESYLATE
Active strength
5 mg/1
Pharmacologic classes
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
1f1c6e4b-bbad-4649-afd1-7a1d671db4b1Product name120150316
63ab5fbf-2a6b-c41d-051a-39e845d718b1Product name120140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57664-056-132019-11-27C16284748780-19855d018-db32-cd31-e053-dbdaa90ab51aThese highlights do not include all the information needed to use amlodipine besylate tablets safely and effectively. See full prescribing information for amlodipine besylate tablets. Amlodipine Besylate Tablets, USP for oral administration Initial U.S. Approval: 1987
57664-056-182019-11-27C16284748780-19855d018-db32-cd31-e053-dbdaa90ab51aThese highlights do not include all the information needed to use amlodipine besylate tablets safely and effectively. See full prescribing information for amlodipine besylate tablets. Amlodipine Besylate Tablets, USP for oral administration Initial U.S. Approval: 1987
57664-056-992019-11-27C16284748780-19855d018-db32-cd31-e053-dbdaa90ab51aThese highlights do not include all the information needed to use amlodipine besylate tablets safely and effectively. See full prescribing information for amlodipine besylate tablets. Amlodipine Besylate Tablets, USP for oral administration Initial U.S. Approval: 1987

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57664-056-13Amlodipine Besylate500 in 1 BOTTLETABLET5002
57664-056-18Amlodipine Besylate1000 in 1 BOTTLETABLET10002
57664-056-99Amlodipine Besylate90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57664-056-13EA - Each57664-056bc465286-a3df-4da7-8b1f-fbdc79714dd712013-02-13
57664-056-18EA - Each57664-05655ce5da4-fc2b-419d-82ff-d033edac34c512013-02-13
57664-056-99EA - Each57664-05693a6f1b1-fbba-4741-8aea-be90635077ea12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HAMLODIPINE BESYLATE TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]2
AMLODIPINEACTIVE MOIETY1J444QC288AMLODIPINE BESYLATE TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMLODIPINE BESYLATE TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMLODIPINE BESYLATE TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMLODIPINE BESYLATE TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAMLODIPINE BESYLATE TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57664-056AMLODIPINE BESYLATE TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]2Legacy NDC, 3 package rows20121109_42881d5b-7e35-496e-aeeb-8da760d4267c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308135amLODIPine besylate 10 MG Oral TabletPSN42881d5b-7e35-496e-aeeb-8da760d4267c2
308136amLODIPine besylate 2.5 MG Oral TabletPSN42881d5b-7e35-496e-aeeb-8da760d4267c2
197361amLODIPine besylate 5 MG Oral TabletPSN42881d5b-7e35-496e-aeeb-8da760d4267c2
308135amlodipine 10 MG Oral TabletSCD42881d5b-7e35-496e-aeeb-8da760d4267c2
308136amlodipine 2.5 MG Oral TabletSCD42881d5b-7e35-496e-aeeb-8da760d4267c2
197361amlodipine 5 MG Oral TabletSCD42881d5b-7e35-496e-aeeb-8da760d4267c2
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSY42881d5b-7e35-496e-aeeb-8da760d4267c2
308136amlodipine (as amlodipine besylate) 2.5 MG Oral TabletSY42881d5b-7e35-496e-aeeb-8da760d4267c2
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSY42881d5b-7e35-496e-aeeb-8da760d4267c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
57664-056-1357664005613500 in 1 BOTTLEHistorical
57664-056-18576640056181000 in 1 BOTTLEHistorical
57664-056-995766400569990 in 1 BOTTLEHistorical