FDA.reportPublic FDA data

Atorvastatin Calcium

Product NDC
0093-5057
11-digit product format
000935057
Labeler code
0093
Product ID
0093-5057_5a4bae3d-a27b-4319-9450-36fdaf57d1e6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA205300
Marketing category
ANDA
Marketing start
2017-05-04
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Atorvastatin Calcium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATORVASTATIN CALCIUM TRIHYDRATE80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii48A5M73Z4Q

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
0093-5057-05Atorvastatin Calcium500 in 1 BOTTLETABLET, FILM COATED50016
0093-5057-98Atorvastatin Calcium90 in 1 BOTTLETABLET, FILM COATED9016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-5057-05EA - Each0093-5057ae417e97-783d-4d61-a33d-da2cbb1430ac12022-06-06
0093-5057-98EA - Each0093-5057011e1dbb-f101-4154-9c99-a21a983f95c712017-05-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-5057ATORVASTATIN CALCIUM TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.]15Current NDC, Legacy NDC, 2 package rows20240622_86841382-4229-4e03-958e-3ac22639efd4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617312atorvastatin calcium 10 MG Oral TabletPSN86841382-4229-4e03-958e-3ac22639efd416
617310atorvastatin calcium 20 MG Oral TabletPSN86841382-4229-4e03-958e-3ac22639efd416
617311atorvastatin calcium 40 MG Oral TabletPSN86841382-4229-4e03-958e-3ac22639efd416
259255atorvastatin calcium 80 MG Oral TabletPSN86841382-4229-4e03-958e-3ac22639efd416
617312atorvastatin 10 MG Oral TabletSCD86841382-4229-4e03-958e-3ac22639efd416
617310atorvastatin 20 MG Oral TabletSCD86841382-4229-4e03-958e-3ac22639efd416
617311atorvastatin 40 MG Oral TabletSCD86841382-4229-4e03-958e-3ac22639efd416
259255atorvastatin 80 MG Oral TabletSCD86841382-4229-4e03-958e-3ac22639efd416
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY86841382-4229-4e03-958e-3ac22639efd416
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY86841382-4229-4e03-958e-3ac22639efd416
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY86841382-4229-4e03-958e-3ac22639efd416
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY86841382-4229-4e03-958e-3ac22639efd416
259255atorvastatin calcium 80 MG Oral TabletPSNbd56a76b-5570-46a7-9399-fc110d913bf93
259255atorvastatin 80 MG Oral TabletSCDbd56a76b-5570-46a7-9399-fc110d913bf93
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSYbd56a76b-5570-46a7-9399-fc110d913bf93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0093-5057-0500093505705500 TABLET, FILM COATED in 1 BOTTLE (0093-5057-05) 2022-05-230000-00-00NoNoCurrent
0093-5057-980009350579890 TABLET, FILM COATED in 1 BOTTLE (0093-5057-98) 2017-05-042027-10-31NoNoCurrent