FDA.reportPublic FDA data

Atorvastatin calcium

Product NDC
70756-250
11-digit product format
707560250
Labeler code
70756
Product ID
70756-250_5a6b2543-e57d-418f-9156-d4aea7a917f1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Lifestar Pharma LLC
Application
ANDA217081
Marketing category
ANDA
Marketing start
2024-01-05
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, 617310, 617311, 617312

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
70756-250-30Atorvastatin calcium30 in 1 BOTTLETABLET, FILM COATED305
70756-250-51Atorvastatin calcium500 in 1 BOTTLETABLET, FILM COATED5005
70756-250-90Atorvastatin calcium90 in 1 BOTTLETABLET, FILM COATED905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70756-250-51EA - Each70756-250541a13b9-2eb7-48f5-8e78-ec1d8d1776aa12024-03-12
70756-250-90EA - Each70756-250944e1580-9ceb-4cfd-a0e3-ce3cb0a6033612024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70756-250ATORVASTATIN CALCIUM TABLET, FILM COATED [LIFESTAR PHARMA LLC]5Current NDC, 3 package rows20240504_de8f2c55-44d2-4e01-b7f2-dfb24f1f8760.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617312atorvastatin calcium 10 MG Oral TabletPSNde8f2c55-44d2-4e01-b7f2-dfb24f1f87605
617310atorvastatin calcium 20 MG Oral TabletPSNde8f2c55-44d2-4e01-b7f2-dfb24f1f87605
617311atorvastatin calcium 40 MG Oral TabletPSNde8f2c55-44d2-4e01-b7f2-dfb24f1f87605
259255atorvastatin calcium 80 MG Oral TabletPSNde8f2c55-44d2-4e01-b7f2-dfb24f1f87605
617312atorvastatin 10 MG Oral TabletSCDde8f2c55-44d2-4e01-b7f2-dfb24f1f87605
617310atorvastatin 20 MG Oral TabletSCDde8f2c55-44d2-4e01-b7f2-dfb24f1f87605
617311atorvastatin 40 MG Oral TabletSCDde8f2c55-44d2-4e01-b7f2-dfb24f1f87605
259255atorvastatin 80 MG Oral TabletSCDde8f2c55-44d2-4e01-b7f2-dfb24f1f87605
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSYde8f2c55-44d2-4e01-b7f2-dfb24f1f87605
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSYde8f2c55-44d2-4e01-b7f2-dfb24f1f87605
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSYde8f2c55-44d2-4e01-b7f2-dfb24f1f87605
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSYde8f2c55-44d2-4e01-b7f2-dfb24f1f87605
259255atorvastatin calcium 80 MG Oral TabletPSN61c29f52-7dcd-44ac-a8aa-4f54f0901f043
259255atorvastatin 80 MG Oral TabletSCD61c29f52-7dcd-44ac-a8aa-4f54f0901f043
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY61c29f52-7dcd-44ac-a8aa-4f54f0901f043
259255atorvastatin calcium 80 MG Oral TabletPSN3eee2ddb-851e-15ad-e063-6394a90a173a1
259255atorvastatin 80 MG Oral TabletSCD3eee2ddb-851e-15ad-e063-6394a90a173a1
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY3eee2ddb-851e-15ad-e063-6394a90a173a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70756-250-307075602503030 TABLET, FILM COATED in 1 BOTTLE (70756-250-30) 2024-01-05NoNoHistorical
70756-250-5170756025051500 TABLET, FILM COATED in 1 BOTTLE (70756-250-51) 2024-01-05NoNoHistorical
70756-250-907075602509090 TABLET, FILM COATED in 1 BOTTLE (70756-250-90) 2024-01-05NoNoHistorical