FDA.reportPublic FDA data

AMLODIPINE BESYLATE

Product NDC
69097-128
11-digit product format
690970128
Labeler code
69097
Product ID
69097-128_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
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
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 BESYLATE10 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
69097-128-05AMLODIPINE BESYLATE90 in 1 BOTTLETABLET9012
69097-128-15AMLODIPINE BESYLATE1000 in 1 BOTTLETABLET100012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-128-05EA - Each69097-1288bec5807-607f-482f-a0fa-b6a4daa15b9e12015-06-09
69097-128-15EA - Each69097-12854959fb9-53b9-4dde-8eeb-41a528afdfe912015-06-09

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
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HAMLODIPINE BESYLATE TABLET [DIRECTRX]1
AMLODIPINEACTIVE MOIETY1J444QC288AMLODIPINE BESYLATE TABLET [DIRECTRX]1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JAMLODIPINE BESYLATE TABLET [DIRECTRX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMLODIPINE BESYLATE TABLET [DIRECTRX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMLODIPINE BESYLATE TABLET [DIRECTRX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMLODIPINE BESYLATE TABLET [DIRECTRX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-128AMLODIPINE 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
308135amLODIPine besylate 10 MG Oral TabletPSN215e0890-0484-45e8-a731-aea53821ad8e15
308135amlodipine 10 MG Oral TabletSCD215e0890-0484-45e8-a731-aea53821ad8e15
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSY215e0890-0484-45e8-a731-aea53821ad8e15
308135amLODIPine besylate 10 MG Oral TabletPSNa6fa364c-3ad6-4bf9-b9ee-5ec3b1a7eb5514
308135amlodipine 10 MG Oral TabletSCDa6fa364c-3ad6-4bf9-b9ee-5ec3b1a7eb5514
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSYa6fa364c-3ad6-4bf9-b9ee-5ec3b1a7eb5514
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 TabletPSN7dc972ad-2866-39a9-e053-2a91aa0a62ce8
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 TabletSCD7dc972ad-2866-39a9-e053-2a91aa0a62ce8
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
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSY7dc972ad-2866-39a9-e053-2a91aa0a62ce8
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 TabletPSNb2ce9cd0-1c79-4b35-b87b-daff2c381a735
197361amLODIPine besylate 5 MG Oral TabletPSNb2ce9cd0-1c79-4b35-b87b-daff2c381a735
308135amlodipine 10 MG Oral TabletSCDb2ce9cd0-1c79-4b35-b87b-daff2c381a735
197361amlodipine 5 MG Oral TabletSCDb2ce9cd0-1c79-4b35-b87b-daff2c381a735
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSYb2ce9cd0-1c79-4b35-b87b-daff2c381a735
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSYb2ce9cd0-1c79-4b35-b87b-daff2c381a735
308135amLODIPine besylate 10 MG Oral TabletPSN6440ca1f-5377-3c18-e053-2991aa0ab0124
308135amLODIPine besylate 10 MG Oral TabletPSN410aa0a5-43cf-455c-b51d-7dfbc24eee324
308135amLODIPine besylate 10 MG Oral TabletPSN03fe9ad2-3a1a-78db-e063-6294a90a2ed34
308135amlodipine 10 MG Oral TabletSCD6440ca1f-5377-3c18-e053-2991aa0ab0124
308135amlodipine 10 MG Oral TabletSCD410aa0a5-43cf-455c-b51d-7dfbc24eee324
308135amlodipine 10 MG Oral TabletSCD03fe9ad2-3a1a-78db-e063-6294a90a2ed34
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSY6440ca1f-5377-3c18-e053-2991aa0ab0124
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSY410aa0a5-43cf-455c-b51d-7dfbc24eee324
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSY03fe9ad2-3a1a-78db-e063-6294a90a2ed34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69097-128-056909701280590 TABLET in 1 BOTTLE (69097-128-05) 90 tablet2007-09-260000-00-00NoNoCurrent
69097-128-15690970128151000 TABLET in 1 BOTTLE (69097-128-15) 1000 tablet2007-09-260000-00-00NoNoCurrent