FDA.reportPublic FDA data

AMLODIPINE BESYLATE

Product NDC
61919-295
11-digit product format
619190295
Labeler code
61919
Product ID
61919-295_9c592084-9421-c00b-e053-2a95a90a5790
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMLODIPINE BESYLATE
Dosage form
TABLET
Route
ORAL
Labeler
Direct Rx
Application
ANDA077955
Marketing category
ANDA
Marketing start
2014-01-01
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
No
Listing certified through
2021-12-31
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
61919-295-302023-01-30C16284748780-1f386c64a-090c-0266-e053-dadaa90a7c1aAMLODIPINE BESYLATE
61919-295-712023-01-30C16284748780-1f386c64a-090c-0266-e053-dadaa90a7c1aAMLODIPINE BESYLATE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-295-30AMLODIPINE BESYLATE30 in 1 BOTTLETABLET305
61919-295-71AMLODIPINE BESYLATE100 in 1 BOTTLETABLET1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-295-30EA - Each61919-295c9fdd6c0-97aa-4461-8df1-c2b008fe8c0f12014-12-01
61919-295-71EA - Each61919-29576eefe61-ab90-4a7b-9492-eb8604d334ec12016-12-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HAMLODIPINE BESYLATE TABLET [DIRECT RX]1
AMLODIPINEACTIVE MOIETY1J444QC288AMLODIPINE BESYLATE TABLET [DIRECT RX]1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JAMLODIPINE BESYLATE TABLET [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMLODIPINE BESYLATE TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMLODIPINE BESYLATE TABLET [DIRECT RX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMLODIPINE BESYLATE TABLET [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-295AMLODIPINE BESYLATE TABLET [DIRECT RX]5Legacy NDC, 2 package rows20200125_2829814d-739d-4ff4-9371-bee70bf32248.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197361amLODIPine besylate 5 MG Oral TabletPSN2829814d-739d-4ff4-9371-bee70bf322485
197361amlodipine 5 MG Oral TabletSCD2829814d-739d-4ff4-9371-bee70bf322485
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSY2829814d-739d-4ff4-9371-bee70bf322485

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-295-306191902953030 TABLET in 1 BOTTLE (61919-295-30) 30 tablet2014-01-010000-00-00NoNoCurrent
61919-295-7161919029571100 TABLET in 1 BOTTLE (61919-295-71) 100 tablet2014-01-010000-00-00NoNoCurrent