FDA.reportPublic FDA data

atorvastatin calcium

Product NDC
70710-1772
11-digit product format
707101772
Labeler code
70710
Product ID
70710-1772_223716b7-8d87-4704-a08f-799e2cb5c29e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
atorvastatin calcium
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA206536
Marketing category
ANDA
Marketing start
2024-06-12
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
70710-1772-0atorvastatin calcium1000 in 1 BOTTLETABLET10003
70710-1772-5atorvastatin calcium500 in 1 BOTTLETABLET5003
70710-1772-9atorvastatin calcium90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70710-1772-0EA - Each70710-17729721da60-acfd-44dc-9fc1-9b50a4c5387d12024-08-12
70710-1772-9EA - Each70710-1772f9e19d42-a53b-4d7b-8107-3fc98592860e12024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1772ATORVASTATIN CALCIUM TABLET [ZYDUS PHARMACEUTICALS USA INC.]2Current NDC, 3 package rows20240618_55ad4a90-d177-4cce-b7ec-cb75067f6c14.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617312atorvastatin calcium 10 MG Oral TabletPSN55ad4a90-d177-4cce-b7ec-cb75067f6c143
617310atorvastatin calcium 20 MG Oral TabletPSN55ad4a90-d177-4cce-b7ec-cb75067f6c143
617311atorvastatin calcium 40 MG Oral TabletPSN55ad4a90-d177-4cce-b7ec-cb75067f6c143
259255atorvastatin calcium 80 MG Oral TabletPSN55ad4a90-d177-4cce-b7ec-cb75067f6c143
617312atorvastatin 10 MG Oral TabletSCD55ad4a90-d177-4cce-b7ec-cb75067f6c143
617310atorvastatin 20 MG Oral TabletSCD55ad4a90-d177-4cce-b7ec-cb75067f6c143
617311atorvastatin 40 MG Oral TabletSCD55ad4a90-d177-4cce-b7ec-cb75067f6c143
259255atorvastatin 80 MG Oral TabletSCD55ad4a90-d177-4cce-b7ec-cb75067f6c143
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY55ad4a90-d177-4cce-b7ec-cb75067f6c143
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY55ad4a90-d177-4cce-b7ec-cb75067f6c143
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY55ad4a90-d177-4cce-b7ec-cb75067f6c143
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY55ad4a90-d177-4cce-b7ec-cb75067f6c143
617311atorvastatin calcium 40 MG Oral TabletPSNf6bc1ac6-c96c-4ecf-9935-733587ad61071
617311atorvastatin calcium 40 MG Oral TabletPSN54f93ed0-64ef-46bb-aab6-a8dd5dc4c0351
617311atorvastatin 40 MG Oral TabletSCDf6bc1ac6-c96c-4ecf-9935-733587ad61071
617311atorvastatin 40 MG Oral TabletSCD54f93ed0-64ef-46bb-aab6-a8dd5dc4c0351
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSYf6bc1ac6-c96c-4ecf-9935-733587ad61071
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY54f93ed0-64ef-46bb-aab6-a8dd5dc4c0351

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70710-1772-0707101772001000 TABLET in 1 BOTTLE (70710-1772-0) 1000 tablet2024-06-12NoNoHistorical
70710-1772-570710177205500 TABLET in 1 BOTTLE (70710-1772-5) 500 tablet2024-06-12NoNoHistorical
70710-1772-97071017720990 TABLET in 1 BOTTLE (70710-1772-9) 90 tablet2024-06-12NoNoHistorical