Amlodipine Besylate

Product NDC
55700-541
11-digit product format
557000541
Labeler code
55700
Product ID
55700-541_7aa1f125-789d-4c41-917b-2e879b430beb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine besylate
Dosage form
TABLET
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA078925
Marketing category
ANDA
Marketing start
2017-08-11
Marketing end
0000-00-00
Substance
AMLODIPINE BESYLATE
Active strength
10 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
2023-12-31
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55700-541-30Amlodipine Besylate30 in 1 BOTTLETABLET3011
55700-541-90Amlodipine Besylate90 in 1 BOTTLETABLET9011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55700-541AMLODIPINE BESYLATE TABLET [QUALITY CARE PRODUCTS, LLC]11Legacy NDC, 2 package rows20241219_6b7c18ef-3a85-4ae3-9135-7ac30a0dde08.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308135amLODIPine besylate 10 MG Oral TabletPSN6b7c18ef-3a85-4ae3-9135-7ac30a0dde0811
197361amLODIPine besylate 5 MG Oral TabletPSN6b7c18ef-3a85-4ae3-9135-7ac30a0dde0811
308135amlodipine 10 MG Oral TabletSCD6b7c18ef-3a85-4ae3-9135-7ac30a0dde0811
197361amlodipine 5 MG Oral TabletSCD6b7c18ef-3a85-4ae3-9135-7ac30a0dde0811
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSY6b7c18ef-3a85-4ae3-9135-7ac30a0dde0811
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSY6b7c18ef-3a85-4ae3-9135-7ac30a0dde0811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-541-305570005413030 TABLET in 1 BOTTLE (55700-541-30) 30 tablet2017-08-110000-00-00NoNoCurrent
55700-541-905570005419090 TABLET in 1 BOTTLE (55700-541-90) 90 tablet2017-08-180000-00-00NoNoCurrent