FDA.reportPublic FDA data

Atorvastatin Calcium

Product NDC
55111-123
11-digit product format
551110123
Labeler code
55111
Product ID
55111-123_36e09eff-3948-2638-b633-d5ec2bc03d2a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin Calcium
Dosage form
TABLET
Route
ORAL
Labeler
Dr. Reddy's Laboratories Limited
Application
ANDA091650
Marketing category
ANDA
Marketing start
2012-07-17
Substance
ATORVASTATIN CALCIUM TRIHYDRATE
Active strength
40 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 TRIHYDRATE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii48A5M73Z4Q
Rxcui617310, 617311, 617312

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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
55111-123-05Atorvastatin Calcium500 in 1 BOTTLETABLET50024
55111-123-10Atorvastatin Calcium1000 in 1 BOTTLETABLET100024
55111-123-30Atorvastatin Calcium30 in 1 BOTTLETABLET3024
55111-123-60Atorvastatin Calcium60 in 1 BOTTLETABLET6024
55111-123-90Atorvastatin Calcium90 in 1 BOTTLETABLET9024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-123-05EA - Each55111-1233d39cc84-f50e-43e2-8035-8321c4b69da512013-02-13
55111-123-90EA - Each55111-123472c8f4d-9ca3-47c8-a5c4-e0c6990568b012013-02-13

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
hypromellosesINACTIVE INGREDIENT3NXW29V3WOATORVASTATIN CALCIUM TABLET [DR. REDDY'S LABORATORIES LIMITED]11
isopropyl alcoholINACTIVE INGREDIENTND2M416302ATORVASTATIN CALCIUM TABLET [DR. REDDY'S LABORATORIES LIMITED]11
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XATORVASTATIN 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
methylene chlorideINACTIVE INGREDIENT588X2YUY0AATORVASTATIN CALCIUM TABLET [DR. REDDY'S LABORATORIES LIMITED]11
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AATORVASTATIN 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
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPATORVASTATIN CALCIUM TABLET [DR. REDDY'S LABORATORIES LIMITED]11
ATORVASTATIN CALCIUMACTIVE INGREDIENT48A5M73Z4QATORVASTATIN CALCIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
Atorvastatin CalciumACTIVE INGREDIENT48A5M73Z4QATORVASTATIN CALCIUM TABLET, FILM COATED [DIRECTRX]1
ATORVASTATINACTIVE MOIETYA0JWA85V8FATORVASTATIN CALCIUM TABLET, FILM COATED [DIRECTRX]1
ATORVASTATINACTIVE MOIETYA0JWA85V8FATORVASTATIN CALCIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATORVASTATIN CALCIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UATORVASTATIN CALCIUM TABLET, FILM COATED [DIRECTRX]1
crospovidoneINACTIVE INGREDIENT68401960MKATORVASTATIN CALCIUM TABLET, FILM COATED [DIRECTRX]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKATORVASTATIN CALCIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
Hydroxypropyl Cellulose (Type H)INACTIVE INGREDIENTRFW2ET671PATORVASTATIN CALCIUM TABLET, FILM COATED [DIRECTRX]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PATORVASTATIN CALCIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOATORVASTATIN CALCIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
hypromellosesINACTIVE INGREDIENT3NXW29V3WOATORVASTATIN CALCIUM TABLET, FILM COATED [DIRECTRX]1
isopropyl alcoholINACTIVE INGREDIENTND2M416302ATORVASTATIN CALCIUM TABLET, FILM COATED [DIRECTRX]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302ATORVASTATIN CALCIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XATORVASTATIN CALCIUM TABLET, FILM COATED [DIRECTRX]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XATORVASTATIN CALCIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
magnesium stearateINACTIVE INGREDIENT70097M6I30ATORVASTATIN CALCIUM TABLET, FILM COATED [DIRECTRX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATORVASTATIN CALCIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
methyl alcoholINACTIVE INGREDIENTY4S76JWI15ATORVASTATIN CALCIUM TABLET, FILM COATED [DIRECTRX]1
METHYL ALCOHOLINACTIVE INGREDIENTY4S76JWI15ATORVASTATIN CALCIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
METHYLENE CHLORIDEINACTIVE INGREDIENT588X2YUY0AATORVASTATIN CALCIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
methylene chlorideINACTIVE INGREDIENT588X2YUY0AATORVASTATIN CALCIUM TABLET, FILM COATED [DIRECTRX]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AATORVASTATIN CALCIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AATORVASTATIN CALCIUM TABLET, FILM COATED [DIRECTRX]1
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOATORVASTATIN CALCIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
sodium bicarbonateINACTIVE INGREDIENT8MDF5V39QOATORVASTATIN CALCIUM TABLET, FILM COATED [DIRECTRX]1
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JATORVASTATIN CALCIUM TABLET, FILM COATED [DIRECTRX]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JATORVASTATIN CALCIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPATORVASTATIN CALCIUM TABLET, FILM COATED [DIRECTRX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPATORVASTATIN CALCIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-123ATORVASTATIN CALCIUM TABLET [DR. REDDY'S LABORATORIES LIMITED]24Current NDC, Legacy NDC, 5 package rows20210925_901550e6-22be-68c9-eb86-f85a9c9dd998.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617312atorvastatin calcium 10 MG Oral TabletPSN901550e6-22be-68c9-eb86-f85a9c9dd99824
617310atorvastatin calcium 20 MG Oral TabletPSN901550e6-22be-68c9-eb86-f85a9c9dd99824
617311atorvastatin calcium 40 MG Oral TabletPSN901550e6-22be-68c9-eb86-f85a9c9dd99824
617312atorvastatin 10 MG Oral TabletSCD901550e6-22be-68c9-eb86-f85a9c9dd99824
617310atorvastatin 20 MG Oral TabletSCD901550e6-22be-68c9-eb86-f85a9c9dd99824
617311atorvastatin 40 MG Oral TabletSCD901550e6-22be-68c9-eb86-f85a9c9dd99824
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY901550e6-22be-68c9-eb86-f85a9c9dd99824
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY901550e6-22be-68c9-eb86-f85a9c9dd99824
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY901550e6-22be-68c9-eb86-f85a9c9dd99824
617312atorvastatin calcium 10 MG Oral TabletPSNeab51d98-81bc-465f-9899-eec94d89aab56
617310atorvastatin calcium 20 MG Oral TabletPSNeab51d98-81bc-465f-9899-eec94d89aab56
617311atorvastatin calcium 40 MG Oral TabletPSNeab51d98-81bc-465f-9899-eec94d89aab56
617312atorvastatin 10 MG Oral TabletSCDeab51d98-81bc-465f-9899-eec94d89aab56
617310atorvastatin 20 MG Oral TabletSCDeab51d98-81bc-465f-9899-eec94d89aab56
617311atorvastatin 40 MG Oral TabletSCDeab51d98-81bc-465f-9899-eec94d89aab56
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSYeab51d98-81bc-465f-9899-eec94d89aab56
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSYeab51d98-81bc-465f-9899-eec94d89aab56
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSYeab51d98-81bc-465f-9899-eec94d89aab56
617311atorvastatin calcium 40 MG Oral TabletPSN4eb6db6a-3496-378c-e054-00144ff8d46c4
617311atorvastatin 40 MG Oral TabletSCD4eb6db6a-3496-378c-e054-00144ff8d46c4
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY4eb6db6a-3496-378c-e054-00144ff8d46c4
617310atorvastatin calcium 20 MG Oral TabletPSNf12f81e5-634d-480c-b607-53ec5cbad03f1
617311atorvastatin calcium 40 MG Oral TabletPSN93e8183a-37b3-48d5-a510-41c35a093f0c1
617311atorvastatin calcium 40 MG Oral TabletPSNf12f81e5-634d-480c-b607-53ec5cbad03f1
617310atorvastatin 20 MG Oral TabletSCDf12f81e5-634d-480c-b607-53ec5cbad03f1
617311atorvastatin 40 MG Oral TabletSCD93e8183a-37b3-48d5-a510-41c35a093f0c1
617311atorvastatin 40 MG Oral TabletSCDf12f81e5-634d-480c-b607-53ec5cbad03f1
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSYf12f81e5-634d-480c-b607-53ec5cbad03f1
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY93e8183a-37b3-48d5-a510-41c35a093f0c1
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSYf12f81e5-634d-480c-b607-53ec5cbad03f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-123-0555111012305500 TABLET in 1 BOTTLE (55111-123-05) 500 tablet2012-07-170000-00-00NoNoCurrent
55111-123-10551110123101000 TABLET in 1 BOTTLE (55111-123-10) 1000 tablet2012-07-170000-00-00NoNoCurrent
55111-123-305511101233030 TABLET in 1 BOTTLE (55111-123-30) 30 tablet2012-07-170000-00-00NoNoCurrent
55111-123-605511101236060 TABLET in 1 BOTTLE (55111-123-60) 60 tablet2012-07-170000-00-00NoNoCurrent
55111-123-905511101239090 TABLET in 1 BOTTLE (55111-123-90) 90 tablet2012-07-170000-00-00NoNoCurrent