FDA.reportPublic FDA data

Lipitor

Product NDC
0071-0157
11-digit product format
000710157
Labeler code
0071
Product ID
0071-0157_6202c6a5-77e4-437a-859f-2ebe201f1c82
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
atorvastatin calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Parke-Davis Div of Pfizer Inc
Application
NDA020702
Marketing category
NDA
Marketing start
1996-12-17
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fa898d56-9495-d6f0-309b-68a5d8e3914aProduct name420260305
d25cba4b-d79e-4890-8837-1382f7d09489Product name120231002
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
91774e91-b249-45e3-8ff8-4b5db2927a69Product name120230718
03fb3cda-d60a-4873-94e9-6fa77cfb1a1cProduct name120220302
34152997-af0b-acf4-dcaf-37211afe8ca4Product name920210312
46fdf265-6d5a-1bfb-93db-d82a4ea8aa81Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0071-0157-23EA - Each0071-0157312bfb43-2b7d-46bf-a816-bf88ed28414412012-07-24
0071-0157-40EA - Each0071-015773fb4a66-18e2-485b-b50a-454c1716797912012-07-24
0071-0157-73EA - Each0071-015791ef3746-0f75-462e-b102-b287be8bd01e12012-07-24
0071-0157-88EA - Each0071-01578101d24e-279a-46b9-be36-ac26424da57612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATORVASTATIN CALCIUM TRIHYDRATEACTIVE INGREDIENT48A5M73Z4QLIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]15
ATORVASTATINACTIVE MOIETYA0JWA85V8FLIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]15
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKLIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]15
CANDELILLA WAXINACTIVE INGREDIENTWL0328HX19LIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]15
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]15
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]15
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PLIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]15
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]15
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]15
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]15
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]15
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HLIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]15
TALCINACTIVE INGREDIENT7SEV7J4R1ULIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]15
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]15
ATORVASTATIN CALCIUMACTIVE INGREDIENT48A5M73Z4QLIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC]5
ATORVASTATINACTIVE MOIETYA0JWA85V8FLIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC]5
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKLIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC]5
CANDELILLA WAXINACTIVE INGREDIENTWL0328HX19LIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC]5
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PLIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC]5
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ALIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC]5
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HLIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC]5
TALCINACTIVE INGREDIENT7SEV7J4R1ULIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC]5
atorvastatin calciumACTIVE INGREDIENT48A5M73Z4QLIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
atorvastatinACTIVE MOIETYA0JWA85V8FLIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
calcium carbonateINACTIVE INGREDIENTH0G9379FGKLIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
candelilla waxINACTIVE INGREDIENTWL0328HX19LIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61ULIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48LIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
hydroxypropyl celluloseINACTIVE INGREDIENTRFW2ET671PLIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XLIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
magnesium stearateINACTIVE INGREDIENT70097M6I30LIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
polyethylene glycolINACTIVE INGREDIENT3WJQ0SDW1ALIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HLIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
talcINACTIVE INGREDIENT7SEV7J4R1ULIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPLIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0071-0157LIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC]42Legacy NDC20240502_c6e131fe-e7df-4876-83f7-9156fc4e8228.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617312atorvastatin calcium 10 MG Oral TabletPSN10a7ba02-42d6-4cae-8904-b256e2da54965
617310atorvastatin calcium 20 MG Oral TabletPSN10a7ba02-42d6-4cae-8904-b256e2da54965
617311atorvastatin calcium 40 MG Oral TabletPSN10a7ba02-42d6-4cae-8904-b256e2da54965
259255atorvastatin calcium 80 MG Oral TabletPSN10a7ba02-42d6-4cae-8904-b256e2da54965
617314Lipitor 10 MG Oral TabletPSN10a7ba02-42d6-4cae-8904-b256e2da54965
617318Lipitor 20 MG Oral TabletPSN10a7ba02-42d6-4cae-8904-b256e2da54965
617320Lipitor 40 MG Oral TabletPSN10a7ba02-42d6-4cae-8904-b256e2da54965
262095Lipitor 80 MG Oral TabletPSN10a7ba02-42d6-4cae-8904-b256e2da54965
617314atorvastatin 10 MG Oral Tablet [Lipitor]SBD10a7ba02-42d6-4cae-8904-b256e2da54965
617318atorvastatin 20 MG Oral Tablet [Lipitor]SBD10a7ba02-42d6-4cae-8904-b256e2da54965
617320atorvastatin 40 MG Oral Tablet [Lipitor]SBD10a7ba02-42d6-4cae-8904-b256e2da54965
262095atorvastatin 80 MG Oral Tablet [Lipitor]SBD10a7ba02-42d6-4cae-8904-b256e2da54965
617312atorvastatin 10 MG Oral TabletSCD10a7ba02-42d6-4cae-8904-b256e2da54965
617310atorvastatin 20 MG Oral TabletSCD10a7ba02-42d6-4cae-8904-b256e2da54965
617311atorvastatin 40 MG Oral TabletSCD10a7ba02-42d6-4cae-8904-b256e2da54965
259255atorvastatin 80 MG Oral TabletSCD10a7ba02-42d6-4cae-8904-b256e2da54965
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY10a7ba02-42d6-4cae-8904-b256e2da54965
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY10a7ba02-42d6-4cae-8904-b256e2da54965
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY10a7ba02-42d6-4cae-8904-b256e2da54965
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY10a7ba02-42d6-4cae-8904-b256e2da54965
617314Lipitor (as atorvastatin calcium) 10 MG Oral TabletSY10a7ba02-42d6-4cae-8904-b256e2da54965
617318Lipitor (as atorvastatin calcium) 20 MG Oral TabletSY10a7ba02-42d6-4cae-8904-b256e2da54965
617320Lipitor (as atorvastatin calcium) 40 MG Oral TabletSY10a7ba02-42d6-4cae-8904-b256e2da54965
262095Lipitor (as atorvastatin calcium) 80 MG Oral TabletSY10a7ba02-42d6-4cae-8904-b256e2da54965
617314Lipitor 10 MG Oral TabletSY10a7ba02-42d6-4cae-8904-b256e2da54965
617318Lipitor 20 MG Oral TabletSY10a7ba02-42d6-4cae-8904-b256e2da54965
617320Lipitor 40 MG Oral TabletSY10a7ba02-42d6-4cae-8904-b256e2da54965
262095Lipitor 80 MG Oral TabletSY10a7ba02-42d6-4cae-8904-b256e2da54965
617311atorvastatin calcium 40 MG Oral TabletPSNa3c08a6d-f986-4efc-9f96-3f0e652704dc1
617320Lipitor 40 MG Oral TabletPSNa3c08a6d-f986-4efc-9f96-3f0e652704dc1
617320atorvastatin 40 MG Oral Tablet [Lipitor]SBDa3c08a6d-f986-4efc-9f96-3f0e652704dc1
617311atorvastatin 40 MG Oral TabletSCDa3c08a6d-f986-4efc-9f96-3f0e652704dc1
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSYa3c08a6d-f986-4efc-9f96-3f0e652704dc1
617320Lipitor (as atorvastatin calcium) 40 MG Oral TabletSYa3c08a6d-f986-4efc-9f96-3f0e652704dc1
617320Lipitor 40 MG Oral TabletSYa3c08a6d-f986-4efc-9f96-3f0e652704dc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0071-0157-230007101572390 TABLET, FILM COATED in 1 BOTTLE (0071-0157-23) 1996-12-170000-00-00NoNoCurrent
0071-0157-4000071015740100 BLISTER PACK in 1 CARTON (0071-0157-40) > 1 TABLET, FILM COATED in 1 BLISTER PACK100 blister pack1996-12-170000-00-00NoNoCurrent
0071-0157-97000710157971 PACKET in 1 CARTON (0071-0157-97) > 7 TABLET, FILM COATED in 1 PACKET1 packet1996-12-170000-00-00NoNoCurrent