FDA.reportPublic FDA data

Atorvastatin Calcium

Product NDC
42385-943
11-digit product format
423850943
Labeler code
42385
Product ID
42385-943_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
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
42385-943-01Atorvastatin Calcium100 in 1 BOTTLETABLET, FILM COATED1002
42385-943-05Atorvastatin Calcium500 in 1 BOTTLETABLET, FILM COATED5002
42385-943-08Atorvastatin Calcium8 in 1 BLISTER PACKTABLET, FILM COATED82
42385-943-10Atorvastatin Calcium10 in 1 BLISTER PACKTABLET, FILM COATED102
42385-943-11Atorvastatin Calcium1000 in 1 BOTTLETABLET, FILM COATED10002
42385-943-30Atorvastatin Calcium30 in 1 BOTTLETABLET, FILM COATED302
42385-943-64Atorvastatin Calcium08 in 1 CARTONTABLET, FILM COATED082
42385-943-68Atorvastatin Calcium10 in 1 CARTONTABLET, FILM COATED102
42385-943-90Atorvastatin Calcium90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42385-943-01EA - Each42385-943e15f1e19-09c9-4008-9315-928cd76dfeda12025-01-14
42385-943-05EA - Each42385-94316a79a73-b5d9-44d8-bc22-c0e52184824312025-01-14
42385-943-11EA - Each42385-94380fa271a-d50c-4dd6-b978-6c57ccde4ab412025-01-14
42385-943-90EA - Each42385-9433f9c247d-2fde-4102-9b09-d5367537d04812025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42385-943ATORVASTATIN CALCIUM TABLET, FILM COATED [LAURUS LABS LIMITED]1Current NDC, 9 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
42385-943-0142385094301100 TABLET, FILM COATED in 1 BOTTLE (42385-943-01) 2024-01-23NoNoHistorical
42385-943-0542385094305500 TABLET, FILM COATED in 1 BOTTLE (42385-943-05) 2024-01-23NoNoHistorical
42385-943-08423850943088 in 1 BLISTER PACKHistorical
42385-943-104238509431010 in 1 BLISTER PACKHistorical
42385-943-11423850943111000 TABLET, FILM COATED in 1 BOTTLE (42385-943-11) 2024-01-23NoNoHistorical
42385-943-304238509433030 TABLET, FILM COATED in 1 BOTTLE (42385-943-30) 2024-01-23NoNoHistorical
42385-943-64423850943648 BLISTER PACK in 1 CARTON (42385-943-64) / 8 TABLET, FILM COATED in 1 BLISTER PACK (42385-943-08) 8 blister pack2024-01-23NoNoHistorical
42385-943-684238509436810 BLISTER PACK in 1 CARTON (42385-943-68) / 10 TABLET, FILM COATED in 1 BLISTER PACK (42385-943-10) 10 blister pack2024-01-23NoNoHistorical
42385-943-904238509439090 TABLET, FILM COATED in 1 BOTTLE (42385-943-90) 2024-01-23NoNoHistorical