Atorvastatin Calcium

Product NDC
55111-124
11-digit product format
551110124
Labeler code
55111
Product ID
55111-124_3ec2bef7-b820-857f-1c70-e57c2d2c6dbf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin Calcium
Dosage form
TABLET
Route
ORAL
Labeler
Dr. Reddy's Laboratories Limited
Application
ANDA202357
Marketing category
ANDA
Marketing start
2012-07-17
Substance
ATORVASTATIN CALCIUM TRIHYDRATE
Active strength
80 mg/1
Pharmacologic classes
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
Atorvastatin Calcium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATORVASTATIN CALCIUM TRIHYDRATE80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii48A5M73Z4Q
Rxcui259255

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fa898d56-9495-d6f0-309b-68a5d8e3914aProduct name420260305
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
d25cba4b-d79e-4890-8837-1382f7d09489Product name120231002
91774e91-b249-45e3-8ff8-4b5db2927a69Product name120230718
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
03fb3cda-d60a-4873-94e9-6fa77cfb1a1cProduct name120220302
34152997-af0b-acf4-dcaf-37211afe8ca4Product name920210312
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
46fdf265-6d5a-1bfb-93db-d82a4ea8aa81Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55111-124-05Atorvastatin Calcium500 in 1 BOTTLETABLET50023
55111-124-30Atorvastatin Calcium30 in 1 BOTTLETABLET3023
55111-124-60Atorvastatin Calcium60 in 1 BOTTLETABLET6023
55111-124-90Atorvastatin Calcium90 in 1 BOTTLETABLET9023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-124-05EA - Each55111-12494649da3-4923-4bbe-8a9e-7e404b0cea5e12013-02-13
55111-124-90EA - Each55111-12447abfac3-848b-420b-bb02-b8b45193348b12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Atorvastatin CalciumACTIVE INGREDIENT48A5M73Z4QATORVASTATIN CALCIUM TABLET [DR. REDDY'S LABORATORIES LIMITED]11
atorvastatinACTIVE MOIETYA0JWA85V8FATORVASTATIN CALCIUM TABLET [DR. REDDY'S LABORATORIES LIMITED]11
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UATORVASTATIN CALCIUM TABLET [DR. REDDY'S LABORATORIES LIMITED]11
crospovidoneINACTIVE INGREDIENT68401960MKATORVASTATIN CALCIUM TABLET [DR. REDDY'S LABORATORIES LIMITED]11
Hydroxypropyl Cellulose (Type H)INACTIVE INGREDIENTRFW2ET671PATORVASTATIN CALCIUM TABLET [DR. REDDY'S LABORATORIES LIMITED]11
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XATORVASTATIN CALCIUM TABLET [DR. REDDY'S LABORATORIES LIMITED]11
lecithin, soybeanINACTIVE INGREDIENT1DI56QDM62ATORVASTATIN CALCIUM TABLET [DR. REDDY'S LABORATORIES LIMITED]11
magnesium stearateINACTIVE INGREDIENT70097M6I30ATORVASTATIN CALCIUM TABLET [DR. REDDY'S LABORATORIES LIMITED]11
methyl alcoholINACTIVE INGREDIENTY4S76JWI15ATORVASTATIN CALCIUM TABLET [DR. REDDY'S LABORATORIES LIMITED]11
polyvinyl alcoholINACTIVE INGREDIENT532B59J990ATORVASTATIN CALCIUM TABLET [DR. REDDY'S LABORATORIES LIMITED]11
sodium bicarbonateINACTIVE INGREDIENT8MDF5V39QOATORVASTATIN CALCIUM TABLET [DR. REDDY'S LABORATORIES LIMITED]11
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JATORVASTATIN CALCIUM TABLET [DR. REDDY'S LABORATORIES LIMITED]11
talcINACTIVE INGREDIENT7SEV7J4R1UATORVASTATIN CALCIUM TABLET [DR. REDDY'S LABORATORIES LIMITED]11
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPATORVASTATIN CALCIUM TABLET [DR. REDDY'S LABORATORIES LIMITED]11
xanthan gumINACTIVE INGREDIENTTTV12P4NEEATORVASTATIN CALCIUM TABLET [DR. REDDY'S LABORATORIES LIMITED]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-124ATORVASTATIN CALCIUM TABLET [DR. REDDY'S LABORATORIES LIMITED]23Current NDC, Legacy NDC, 4 package rows20211212_6ccdb6f3-22c7-5b48-46bc-ce4a4c65eb4d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
259255atorvastatin calcium 80 MG Oral TabletPSN6ccdb6f3-22c7-5b48-46bc-ce4a4c65eb4d23
259255atorvastatin 80 MG Oral TabletSCD6ccdb6f3-22c7-5b48-46bc-ce4a4c65eb4d23
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY6ccdb6f3-22c7-5b48-46bc-ce4a4c65eb4d23
259255atorvastatin calcium 80 MG Oral TabletPSN74d03dfe-6fe1-42e4-8048-b5b42874da965
259255atorvastatin 80 MG Oral TabletSCD74d03dfe-6fe1-42e4-8048-b5b42874da965
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY74d03dfe-6fe1-42e4-8048-b5b42874da965

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-124-0555111012405500 TABLET in 1 BOTTLE (55111-124-05) 500 tablet2012-07-170000-00-00NoNoCurrent
55111-124-305511101243030 TABLET in 1 BOTTLE (55111-124-30) 30 tablet2012-07-170000-00-00NoNoCurrent
55111-124-605511101246060 TABLET in 1 BOTTLE (55111-124-60) 60 tablet2012-07-170000-00-00NoNoCurrent
55111-124-905511101249090 TABLET in 1 BOTTLE (55111-124-90) 90 tablet2012-07-170000-00-00NoNoCurrent