FDA.reportPublic FDA data

Lipitor

Product NDC
58151-155
11-digit product format
581510155
Labeler code
58151
Product ID
58151-155_e0f7e582-ef7c-4498-9871-55e4f48345ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
atorvastatin calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Viatris Specialty LLC
Application
NDA020702
Marketing category
NDA
Marketing start
2024-05-01
Substance
ATORVASTATIN CALCIUM TRIHYDRATE
Active strength
10 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
Lipitor
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATORVASTATIN CALCIUM TRIHYDRATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii48A5M73Z4Q
Rxcui259255, 262095, 617310, 617311, 617312, 617314, 617318, 617320

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fa898d56-9495-d6f0-309b-68a5d8e3914aProduct name420260305
d25cba4b-d79e-4890-8837-1382f7d09489Product name120231002
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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58151-155-77Lipitor90 in 1 BOTTLETABLET, FILM COATED907

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58151-155LIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [VIATRIS SPECIALTY LLC]7Current NDC, 1 package rows20240627_a60cc18b-0631-4cf0-b021-9f52224ece65.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617312atorvastatin calcium 10 MG Oral TabletPSNa60cc18b-0631-4cf0-b021-9f52224ece657
617310atorvastatin calcium 20 MG Oral TabletPSNa60cc18b-0631-4cf0-b021-9f52224ece657
617311atorvastatin calcium 40 MG Oral TabletPSNa60cc18b-0631-4cf0-b021-9f52224ece657
259255atorvastatin calcium 80 MG Oral TabletPSNa60cc18b-0631-4cf0-b021-9f52224ece657
617314Lipitor 10 MG Oral TabletPSNa60cc18b-0631-4cf0-b021-9f52224ece657
617318Lipitor 20 MG Oral TabletPSNa60cc18b-0631-4cf0-b021-9f52224ece657
617320Lipitor 40 MG Oral TabletPSNa60cc18b-0631-4cf0-b021-9f52224ece657
262095Lipitor 80 MG Oral TabletPSNa60cc18b-0631-4cf0-b021-9f52224ece657
617314atorvastatin 10 MG Oral Tablet [Lipitor]SBDa60cc18b-0631-4cf0-b021-9f52224ece657
617318atorvastatin 20 MG Oral Tablet [Lipitor]SBDa60cc18b-0631-4cf0-b021-9f52224ece657
617320atorvastatin 40 MG Oral Tablet [Lipitor]SBDa60cc18b-0631-4cf0-b021-9f52224ece657
262095atorvastatin 80 MG Oral Tablet [Lipitor]SBDa60cc18b-0631-4cf0-b021-9f52224ece657
617312atorvastatin 10 MG Oral TabletSCDa60cc18b-0631-4cf0-b021-9f52224ece657
617310atorvastatin 20 MG Oral TabletSCDa60cc18b-0631-4cf0-b021-9f52224ece657
617311atorvastatin 40 MG Oral TabletSCDa60cc18b-0631-4cf0-b021-9f52224ece657
259255atorvastatin 80 MG Oral TabletSCDa60cc18b-0631-4cf0-b021-9f52224ece657
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSYa60cc18b-0631-4cf0-b021-9f52224ece657
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSYa60cc18b-0631-4cf0-b021-9f52224ece657
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSYa60cc18b-0631-4cf0-b021-9f52224ece657
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSYa60cc18b-0631-4cf0-b021-9f52224ece657
617314Lipitor (as atorvastatin calcium) 10 MG Oral TabletSYa60cc18b-0631-4cf0-b021-9f52224ece657
617318Lipitor (as atorvastatin calcium) 20 MG Oral TabletSYa60cc18b-0631-4cf0-b021-9f52224ece657
617320Lipitor (as atorvastatin calcium) 40 MG Oral TabletSYa60cc18b-0631-4cf0-b021-9f52224ece657
262095Lipitor (as atorvastatin calcium) 80 MG Oral TabletSYa60cc18b-0631-4cf0-b021-9f52224ece657
617314Lipitor 10 MG Oral TabletSYa60cc18b-0631-4cf0-b021-9f52224ece657
617318Lipitor 20 MG Oral TabletSYa60cc18b-0631-4cf0-b021-9f52224ece657
617320Lipitor 40 MG Oral TabletSYa60cc18b-0631-4cf0-b021-9f52224ece657
262095Lipitor 80 MG Oral TabletSYa60cc18b-0631-4cf0-b021-9f52224ece657

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
58151-155-775815101557790 TABLET, FILM COATED in 1 BOTTLE (58151-155-77) 2024-05-01NoNoCurrent