FDA.reportPublic FDA data

Atorvastatin Calcium

Product NDC
42385-941
11-digit product format
423850941
Labeler code
42385
Product ID
42385-941_ba8208d7-c3b8-4ddc-8826-9f5265513bfa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Laurus Labs Limited
Application
ANDA214513
Marketing category
ANDA
Marketing start
2024-01-23
Substance
ATORVASTATIN CALCIUM TRIHYDRATE
Active strength
20 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 TRIHYDRATE20 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
42385-941-01Atorvastatin Calcium100 in 1 BOTTLETABLET, FILM COATED1002
42385-941-05Atorvastatin Calcium500 in 1 BOTTLETABLET, FILM COATED5002
42385-941-10Atorvastatin Calcium10 in 1 BLISTER PACKTABLET, FILM COATED102
42385-941-11Atorvastatin Calcium1000 in 1 BOTTLETABLET, FILM COATED10002
42385-941-30Atorvastatin Calcium30 in 1 BOTTLETABLET, FILM COATED302
42385-941-68Atorvastatin Calcium10 in 1 CARTONTABLET, FILM COATED102
42385-941-90Atorvastatin Calcium90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42385-941-01EA - Each42385-941fbaea1b2-85df-4353-b6e5-eff159f6289a12025-01-14
42385-941-05EA - Each42385-9417137d9dd-7dc7-4dca-ba9e-71d9b3f6fd6312025-01-14
42385-941-11EA - Each42385-94151039a68-1057-4896-8eb2-bd815907749612025-01-14
42385-941-90EA - Each42385-9415efd61bb-21cb-4ef8-acd3-db46f62d876b12025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42385-941ATORVASTATIN CALCIUM TABLET, FILM COATED [LAURUS LABS LIMITED]1Current NDC, 7 package rows20240208_9f8ca507-b784-4d18-8d3e-d7d68072c416.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617312atorvastatin calcium 10 MG Oral TabletPSN9f8ca507-b784-4d18-8d3e-d7d68072c4162
617310atorvastatin calcium 20 MG Oral TabletPSN9f8ca507-b784-4d18-8d3e-d7d68072c4162
617311atorvastatin calcium 40 MG Oral TabletPSN9f8ca507-b784-4d18-8d3e-d7d68072c4162
259255atorvastatin calcium 80 MG Oral TabletPSN9f8ca507-b784-4d18-8d3e-d7d68072c4162
617312atorvastatin 10 MG Oral TabletSCD9f8ca507-b784-4d18-8d3e-d7d68072c4162
617310atorvastatin 20 MG Oral TabletSCD9f8ca507-b784-4d18-8d3e-d7d68072c4162
617311atorvastatin 40 MG Oral TabletSCD9f8ca507-b784-4d18-8d3e-d7d68072c4162
259255atorvastatin 80 MG Oral TabletSCD9f8ca507-b784-4d18-8d3e-d7d68072c4162
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY9f8ca507-b784-4d18-8d3e-d7d68072c4162
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY9f8ca507-b784-4d18-8d3e-d7d68072c4162
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY9f8ca507-b784-4d18-8d3e-d7d68072c4162
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY9f8ca507-b784-4d18-8d3e-d7d68072c4162

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42385-941-0142385094101100 TABLET, FILM COATED in 1 BOTTLE (42385-941-01) 2024-01-23NoNoHistorical
42385-941-0542385094105500 TABLET, FILM COATED in 1 BOTTLE (42385-941-05) 2024-01-23NoNoHistorical
42385-941-104238509411010 in 1 BLISTER PACKHistorical
42385-941-11423850941111000 TABLET, FILM COATED in 1 BOTTLE (42385-941-11) 2024-01-23NoNoHistorical
42385-941-304238509413030 TABLET, FILM COATED in 1 BOTTLE (42385-941-30) 2024-01-23NoNoHistorical
42385-941-684238509416810 BLISTER PACK in 1 CARTON (42385-941-68) / 10 TABLET, FILM COATED in 1 BLISTER PACK (42385-941-10) 10 blister pack2024-01-23NoNoHistorical
42385-941-904238509419090 TABLET, FILM COATED in 1 BOTTLE (42385-941-90) 2024-01-23NoNoHistorical