FDA.reportPublic FDA data

AMLODIPINE BESYLATE

Product NDC
69097-126
11-digit product format
690970126
Labeler code
69097
Product ID
69097-126_7cbe66f6-99fb-403f-9c6b-e4ecc7549eaf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMLODIPINE BESYLATE
Dosage form
TABLET
Route
ORAL
Labeler
Cipla USA Inc.
Application
ANDA077073
Marketing category
ANDA
Marketing start
2007-09-26
Substance
AMLODIPINE BESYLATE
Active strength
2.5 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
AMLODIPINE BESYLATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMLODIPINE BESYLATE2.5 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
69097-126-05AMLODIPINE BESYLATE90 in 1 BOTTLETABLET9012
69097-126-15AMLODIPINE BESYLATE1000 in 1 BOTTLETABLET100012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-126-05EA - Each69097-12660ea3a69-3947-421c-bdbf-8ca546c0f09412015-06-09
69097-126-15EA - Each69097-126ec017272-b7ed-49a6-acc5-df6b7fa9cb5512015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HAMLODIPINE BESYLATE TABLET [CIPLA USA INC.]3
AMLODIPINEACTIVE MOIETY1J444QC288AMLODIPINE BESYLATE TABLET [CIPLA USA INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMLODIPINE BESYLATE TABLET [CIPLA USA INC.]3
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMLODIPINE BESYLATE TABLET [CIPLA USA INC.]3
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPAMLODIPINE BESYLATE TABLET [CIPLA USA INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMLODIPINE BESYLATE TABLET [CIPLA USA INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMLODIPINE BESYLATE TABLET [CIPLA USA INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-126AMLODIPINE BESYLATE TABLET [CIPLA USA INC.]11Current NDC, Legacy NDC, 2 package rows20220727_5409b296-3bed-47cd-abba-9fe6f6833af6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308136amLODIPine besylate 2.5 MG Oral TabletPSNe01efe66-2f31-4261-92ca-0b41f27104da16
308136amlodipine 2.5 MG Oral TabletSCDe01efe66-2f31-4261-92ca-0b41f27104da16
308136amlodipine (as amlodipine besylate) 2.5 MG Oral TabletSYe01efe66-2f31-4261-92ca-0b41f27104da16
308135amLODIPine besylate 10 MG Oral TabletPSN5409b296-3bed-47cd-abba-9fe6f6833af612
308136amLODIPine besylate 2.5 MG Oral TabletPSN5409b296-3bed-47cd-abba-9fe6f6833af612
197361amLODIPine besylate 5 MG Oral TabletPSN5409b296-3bed-47cd-abba-9fe6f6833af612
308135amlodipine 10 MG Oral TabletSCD5409b296-3bed-47cd-abba-9fe6f6833af612
308136amlodipine 2.5 MG Oral TabletSCD5409b296-3bed-47cd-abba-9fe6f6833af612
197361amlodipine 5 MG Oral TabletSCD5409b296-3bed-47cd-abba-9fe6f6833af612
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSY5409b296-3bed-47cd-abba-9fe6f6833af612
308136amlodipine (as amlodipine besylate) 2.5 MG Oral TabletSY5409b296-3bed-47cd-abba-9fe6f6833af612
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSY5409b296-3bed-47cd-abba-9fe6f6833af612
308135amLODIPine besylate 10 MG Oral TabletPSN16d9eb52-efc1-4ee9-9a60-4d94b6ceef6a8
308136amLODIPine besylate 2.5 MG Oral TabletPSN16d9eb52-efc1-4ee9-9a60-4d94b6ceef6a8
197361amLODIPine besylate 5 MG Oral TabletPSN16d9eb52-efc1-4ee9-9a60-4d94b6ceef6a8
308135amlodipine 10 MG Oral TabletSCD16d9eb52-efc1-4ee9-9a60-4d94b6ceef6a8
308136amlodipine 2.5 MG Oral TabletSCD16d9eb52-efc1-4ee9-9a60-4d94b6ceef6a8
197361amlodipine 5 MG Oral TabletSCD16d9eb52-efc1-4ee9-9a60-4d94b6ceef6a8
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSY16d9eb52-efc1-4ee9-9a60-4d94b6ceef6a8
308136amlodipine (as amlodipine besylate) 2.5 MG Oral TabletSY16d9eb52-efc1-4ee9-9a60-4d94b6ceef6a8
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSY16d9eb52-efc1-4ee9-9a60-4d94b6ceef6a8
308135amLODIPine besylate 10 MG Oral TabletPSN48f94245-3a9d-0b7c-e054-00144ff88e883
308136amLODIPine besylate 2.5 MG Oral TabletPSN48f94245-3a9d-0b7c-e054-00144ff88e883
308135amlodipine 10 MG Oral TabletSCD48f94245-3a9d-0b7c-e054-00144ff88e883
308136amlodipine 2.5 MG Oral TabletSCD48f94245-3a9d-0b7c-e054-00144ff88e883
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSY48f94245-3a9d-0b7c-e054-00144ff88e883
308136amlodipine (as amlodipine besylate) 2.5 MG Oral TabletSY48f94245-3a9d-0b7c-e054-00144ff88e883

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69097-126-056909701260590 TABLET in 1 BOTTLE (69097-126-05) 90 tablet2007-09-260000-00-00NoNoCurrent
69097-126-15690970126151000 TABLET in 1 BOTTLE (69097-126-15) 1000 tablet2007-09-260000-00-00NoNoCurrent