FDA.reportPublic FDA data

Atorvastatin calcium

Product NDC
70756-249
11-digit product format
707560249
Labeler code
70756
Product ID
70756-249_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
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
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
70756-249-12Atorvastatin calcium1000 in 1 BOTTLETABLET, FILM COATED10005
70756-249-30Atorvastatin calcium30 in 1 BOTTLETABLET, FILM COATED305
70756-249-51Atorvastatin calcium500 in 1 BOTTLETABLET, FILM COATED5005
70756-249-90Atorvastatin calcium90 in 1 BOTTLETABLET, FILM COATED905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70756-249-12EA - Each70756-249658eb1a1-d112-495c-bbf6-cae4d36a47ff12024-03-12
70756-249-51EA - Each70756-24998ef71e0-8fff-4eb1-8f2c-be6739214e4e12024-03-12
70756-249-90EA - Each70756-2498bf5a9bd-1c90-4115-b98f-7309fb705b0812024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70756-249ATORVASTATIN CALCIUM TABLET, FILM COATED [LIFESTAR PHARMA LLC]5Current NDC, 4 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
617311atorvastatin calcium 40 MG Oral TabletPSN2e20a00c-b373-3a8c-e063-6294a90a637b2
617311atorvastatin calcium 40 MG Oral TabletPSNbd26679f-f8ff-41d2-a384-bd1f66f8a6142
617311atorvastatin 40 MG Oral TabletSCDbd26679f-f8ff-41d2-a384-bd1f66f8a6142
617311atorvastatin 40 MG Oral TabletSCD2e20a00c-b373-3a8c-e063-6294a90a637b2
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY2e20a00c-b373-3a8c-e063-6294a90a637b2
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSYbd26679f-f8ff-41d2-a384-bd1f66f8a6142
617311atorvastatin calcium 40 MG Oral TabletPSN4847b761-30a5-0a1a-e063-6294a90ad02b1
617311atorvastatin calcium 40 MG Oral TabletPSN2fffae44-e536-9645-e063-6394a90a7ce51
617311atorvastatin 40 MG Oral TabletSCD4847b761-30a5-0a1a-e063-6294a90ad02b1
617311atorvastatin 40 MG Oral TabletSCD2fffae44-e536-9645-e063-6394a90a7ce51
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY4847b761-30a5-0a1a-e063-6294a90ad02b1
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY2fffae44-e536-9645-e063-6394a90a7ce51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70756-249-12707560249121000 TABLET, FILM COATED in 1 BOTTLE (70756-249-12) 2024-01-05NoNoHistorical
70756-249-307075602493030 TABLET, FILM COATED in 1 BOTTLE (70756-249-30) 2024-01-05NoNoHistorical
70756-249-5170756024951500 TABLET, FILM COATED in 1 BOTTLE (70756-249-51) 2024-01-05NoNoHistorical
70756-249-907075602499090 TABLET, FILM COATED in 1 BOTTLE (70756-249-90) 2024-01-05NoNoHistorical