FDA.reportPublic FDA data

Amlodipine besylate and Atorvastatin calcium

Product NDC
43598-323
11-digit product format
435980323
Labeler code
43598
Product ID
43598-323_54058ac6-94e2-d2d3-5c46-886b3478fc76
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine besylate and Atorvastatin calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Dr. Reddy's Laboratories Inc
Application
ANDA203874
Marketing category
ANDA
Marketing start
2014-03-17
Substance
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE
Active strength
2.5; 10 mg/1; mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
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 and Atorvastatin calcium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMLODIPINE BESYLATE2.5 mg/1
ATORVASTATIN CALCIUM TRIHYDRATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii864V2Q084H, 48A5M73Z4Q
Rxcui404011, 404013, 597967, 597971, 597974, 597977, 597980, 597984, 597987, 597990, 597993

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fa898d56-9495-d6f0-309b-68a5d8e3914aProduct name420260305
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265792b3-b999-c010-7364-a7db20b9d4d9Product name520250515
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dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
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34152997-af0b-acf4-dcaf-37211afe8ca4Product name920210312
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
a72887ef-d675-499f-af4b-78688f6855cdProduct name120191002
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
a4484670-2869-6416-f6ff-03b1b3cbd1b0Product name220190415
4a27501f-a987-48a5-99b4-e983d4744d76Product name720181211
18600d07-613d-bf9c-2711-fe40c06f3393Product name520180703
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
bded1554-44de-900a-5297-403365d6d4b2Product name320170110
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
1f1c6e4b-bbad-4649-afd1-7a1d671db4b1Product name120150316
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
46fdf265-6d5a-1bfb-93db-d82a4ea8aa81Product name120140508
63ab5fbf-2a6b-c41d-051a-39e845d718b1Product name120140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43598-323-05Amlodipine besylate and Atorvastatin calcium500 in 1 BOTTLETABLET, FILM COATED50016
43598-323-30Amlodipine besylate and Atorvastatin calcium30 in 1 BOTTLETABLET, FILM COATED3016
43598-323-60Amlodipine besylate and Atorvastatin calcium60 in 1 BOTTLETABLET, FILM COATED6016
43598-323-90Amlodipine besylate and Atorvastatin calcium90 in 1 BOTTLETABLET, FILM COATED9016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-323-30EA - Each43598-323b003aef0-f2d9-4d1b-bce9-cb40c782079012014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
amlodipine besylateACTIVE INGREDIENT864V2Q084HAMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [DR. REDDY'S LABORATORIES INC]7
atorvastatin calciumACTIVE INGREDIENT48A5M73Z4QAMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [DR. REDDY'S LABORATORIES INC]7
amlodipineACTIVE MOIETY1J444QC288AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [DR. REDDY'S LABORATORIES INC]7
atorvastatinACTIVE MOIETYA0JWA85V8FAMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [DR. REDDY'S LABORATORIES INC]7
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UAMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [DR. REDDY'S LABORATORIES INC]7
crospovidoneINACTIVE INGREDIENT68401960MKAMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [DR. REDDY'S LABORATORIES INC]7
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKAMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [DR. REDDY'S LABORATORIES INC]7
hydrogenated soybean lecithinINACTIVE INGREDIENTH1109Z9J4NAMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [DR. REDDY'S LABORATORIES INC]7
Hydroxypropyl Cellulose (Type H)INACTIVE INGREDIENTRFW2ET671PAMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [DR. REDDY'S LABORATORIES INC]7
magnesium stearateINACTIVE INGREDIENT70097M6I30AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [DR. REDDY'S LABORATORIES INC]7
polyethylene glycol 3350INACTIVE INGREDIENTG2M7P15E5PAMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [DR. REDDY'S LABORATORIES INC]7
polyvinyl alcoholINACTIVE INGREDIENT532B59J990AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [DR. REDDY'S LABORATORIES INC]7
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [DR. REDDY'S LABORATORIES INC]7
sodium bicarbonateINACTIVE INGREDIENT8MDF5V39QOAMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [DR. REDDY'S LABORATORIES INC]7
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JAMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [DR. REDDY'S LABORATORIES INC]7
starch, cornINACTIVE INGREDIENTO8232NY3SJAMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [DR. REDDY'S LABORATORIES INC]7
talcINACTIVE INGREDIENT7SEV7J4R1UAMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [DR. REDDY'S LABORATORIES INC]7
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPAMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [DR. REDDY'S LABORATORIES INC]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-323AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM TABLET, FILM COATED [DR. REDDY'S LABORATORIES INC]16Current NDC, Legacy NDC, 4 package rows20210402_abee4a34-89cc-d886-192c-32582ab8f024.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
597987amLODIPine besylate 10 MG / atorvastatin calcium 10 MG Oral TabletPSNabee4a34-89cc-d886-192c-32582ab8f02416
597967amLODIPine besylate 10 MG / atorvastatin calcium 20 MG Oral TabletPSNabee4a34-89cc-d886-192c-32582ab8f02416
597990amLODIPine besylate 10 MG / atorvastatin calcium 40 MG Oral TabletPSNabee4a34-89cc-d886-192c-32582ab8f02416
404013amLODIPine besylate 10 MG / atorvastatin calcium 80 MG Oral TabletPSNabee4a34-89cc-d886-192c-32582ab8f02416
597971amLODIPine besylate 2.5 MG / atorvastatin calcium 10 MG Oral TabletPSNabee4a34-89cc-d886-192c-32582ab8f02416
597974amLODIPine besylate 2.5 MG / atorvastatin calcium 20 MG Oral TabletPSNabee4a34-89cc-d886-192c-32582ab8f02416
597993amLODIPine besylate 2.5 MG / atorvastatin calcium 40 MG Oral TabletPSNabee4a34-89cc-d886-192c-32582ab8f02416
597977amLODIPine besylate 5 MG / atorvastatin calcium 10 MG Oral TabletPSNabee4a34-89cc-d886-192c-32582ab8f02416
597980amLODIPine besylate 5 MG / atorvastatin calcium 20 MG Oral TabletPSNabee4a34-89cc-d886-192c-32582ab8f02416
597984amLODIPine besylate 5 MG / atorvastatin calcium 40 MG Oral TabletPSNabee4a34-89cc-d886-192c-32582ab8f02416
404011amLODIPine besylate 5 MG / atorvastatin calcium 80 MG Oral TabletPSNabee4a34-89cc-d886-192c-32582ab8f02416
597987amlodipine 10 MG / atorvastatin 10 MG Oral TabletSCDabee4a34-89cc-d886-192c-32582ab8f02416
597967amlodipine 10 MG / atorvastatin 20 MG Oral TabletSCDabee4a34-89cc-d886-192c-32582ab8f02416
597990amlodipine 10 MG / atorvastatin 40 MG Oral TabletSCDabee4a34-89cc-d886-192c-32582ab8f02416
404013amlodipine 10 MG / atorvastatin 80 MG Oral TabletSCDabee4a34-89cc-d886-192c-32582ab8f02416
597971amlodipine 2.5 MG / atorvastatin 10 MG Oral TabletSCDabee4a34-89cc-d886-192c-32582ab8f02416
597974amlodipine 2.5 MG / atorvastatin 20 MG Oral TabletSCDabee4a34-89cc-d886-192c-32582ab8f02416
597993amlodipine 2.5 MG / atorvastatin 40 MG Oral TabletSCDabee4a34-89cc-d886-192c-32582ab8f02416
597977amlodipine 5 MG / atorvastatin 10 MG Oral TabletSCDabee4a34-89cc-d886-192c-32582ab8f02416
597980amlodipine 5 MG / atorvastatin 20 MG Oral TabletSCDabee4a34-89cc-d886-192c-32582ab8f02416
597984amlodipine 5 MG / atorvastatin 40 MG Oral TabletSCDabee4a34-89cc-d886-192c-32582ab8f02416
404011amlodipine 5 MG / atorvastatin 80 MG Oral TabletSCDabee4a34-89cc-d886-192c-32582ab8f02416
597987amlodipine (as amlodipine besylate) 10 MG / atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSYabee4a34-89cc-d886-192c-32582ab8f02416
597967amlodipine (as amlodipine besylate) 10 MG / atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSYabee4a34-89cc-d886-192c-32582ab8f02416
597990amlodipine (as amlodipine besylate) 10 MG / atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSYabee4a34-89cc-d886-192c-32582ab8f02416
404013amlodipine (as amlodipine besylate) 10 MG / atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSYabee4a34-89cc-d886-192c-32582ab8f02416
597971amlodipine (as amlodipine besylate) 2.5 MG / atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSYabee4a34-89cc-d886-192c-32582ab8f02416
597974amlodipine (as amlodipine besylate) 2.5 MG / atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSYabee4a34-89cc-d886-192c-32582ab8f02416
597993amlodipine (as amlodipine besylate) 2.5 MG / atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSYabee4a34-89cc-d886-192c-32582ab8f02416
597977amlodipine (as amlodipine besylate) 5 MG / atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSYabee4a34-89cc-d886-192c-32582ab8f02416
597980amlodipine (as amlodipine besylate) 5 MG / atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSYabee4a34-89cc-d886-192c-32582ab8f02416
597984amlodipine (as amlodipine besylate) 5 MG / atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSYabee4a34-89cc-d886-192c-32582ab8f02416
404011amlodipine (as amlodipine besylate) 5 MG / atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSYabee4a34-89cc-d886-192c-32582ab8f02416

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43598-323-0543598032305500 TABLET, FILM COATED in 1 BOTTLE (43598-323-05) 2014-03-170000-00-00NoNoCurrent
43598-323-304359803233030 TABLET, FILM COATED in 1 BOTTLE (43598-323-30) 2014-03-170000-00-00NoNoCurrent
43598-323-604359803236060 TABLET, FILM COATED in 1 BOTTLE (43598-323-60) 2014-03-170000-00-00NoNoCurrent
43598-323-904359803239090 TABLET, FILM COATED in 1 BOTTLE (43598-323-90) 2014-03-170000-00-00NoNoCurrent