FDA.reportPublic FDA data

ATORVASTATIN CALCIUM

Product NDC
42571-173
11-digit product format
425710173
Labeler code
42571
Product ID
42571-173_336c8e4f-ccef-2741-e063-6294a90a4520
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATORVASTATIN CALCIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Micro Labs Limited
Application
ANDA205945
Marketing category
ANDA
Marketing start
2020-01-01
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
42571-173-10ATORVASTATIN CALCIUM1000 in 1 BOTTLETABLET, FILM COATED100012
42571-173-11ATORVASTATIN CALCIUM10 in 1 CARTONTABLET, FILM COATED1012
42571-173-30ATORVASTATIN CALCIUM30 in 1 BOTTLETABLET, FILM COATED3012
42571-173-32ATORVASTATIN CALCIUM10 in 1 BLISTER PACKTABLET, FILM COATED1012
42571-173-90ATORVASTATIN CALCIUM90 in 1 BOTTLETABLET, FILM COATED9012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42571-173-10EA - Each42571-173fb7320b9-e833-428b-944c-456b3525e14d12020-03-10
42571-173-90EA - Each42571-173f69f57f1-0b09-4531-b7e8-40ece2b0459512020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42571-173ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM) TABLET, FILM COATED [MICRO LABS LIMITED]12Current NDC, Legacy NDC, 5 package rows20250424_2e94161c-3360-4fb0-bb3a-048fdc1d137a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617312atorvastatin calcium 10 MG Oral TabletPSN2e94161c-3360-4fb0-bb3a-048fdc1d137a12
617310atorvastatin calcium 20 MG Oral TabletPSN2e94161c-3360-4fb0-bb3a-048fdc1d137a12
617311atorvastatin calcium 40 MG Oral TabletPSN2e94161c-3360-4fb0-bb3a-048fdc1d137a12
259255atorvastatin calcium 80 MG Oral TabletPSN2e94161c-3360-4fb0-bb3a-048fdc1d137a12
617312atorvastatin 10 MG Oral TabletSCD2e94161c-3360-4fb0-bb3a-048fdc1d137a12
617310atorvastatin 20 MG Oral TabletSCD2e94161c-3360-4fb0-bb3a-048fdc1d137a12
617311atorvastatin 40 MG Oral TabletSCD2e94161c-3360-4fb0-bb3a-048fdc1d137a12
259255atorvastatin 80 MG Oral TabletSCD2e94161c-3360-4fb0-bb3a-048fdc1d137a12
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY2e94161c-3360-4fb0-bb3a-048fdc1d137a12
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY2e94161c-3360-4fb0-bb3a-048fdc1d137a12
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY2e94161c-3360-4fb0-bb3a-048fdc1d137a12
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY2e94161c-3360-4fb0-bb3a-048fdc1d137a12
617310atorvastatin calcium 20 MG Oral TabletPSNb8ab666f-cac8-4b21-aeb4-f8ba568e00423
617310atorvastatin 20 MG Oral TabletSCDb8ab666f-cac8-4b21-aeb4-f8ba568e00423
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSYb8ab666f-cac8-4b21-aeb4-f8ba568e00423
617310atorvastatin calcium 20 MG Oral TabletPSN2d93e3c4-59cc-cff4-e063-6394a90a8f7f1
617310atorvastatin calcium 20 MG Oral TabletPSN192dccc0-fd2c-423b-8d4b-360e6727ed2e1
617310atorvastatin 20 MG Oral TabletSCD2d93e3c4-59cc-cff4-e063-6394a90a8f7f1
617310atorvastatin 20 MG Oral TabletSCD192dccc0-fd2c-423b-8d4b-360e6727ed2e1
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY2d93e3c4-59cc-cff4-e063-6394a90a8f7f1
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY192dccc0-fd2c-423b-8d4b-360e6727ed2e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42571-173-10425710173101000 TABLET, FILM COATED in 1 BOTTLE (42571-173-10) 2020-01-010000-00-00NoNoCurrent
42571-173-114257101731110 BLISTER PACK in 1 CARTON (42571-173-11) / 10 TABLET, FILM COATED in 1 BLISTER PACK (42571-173-32) 10 blister pack2020-01-010000-00-00NoNoCurrent
42571-173-304257101733030 TABLET, FILM COATED in 1 BOTTLE (42571-173-30) 2020-01-010000-00-00NoNoCurrent
42571-173-324257101733210 in 1 BLISTER PACKHistorical
42571-173-904257101739090 TABLET, FILM COATED in 1 BOTTLE (42571-173-90) 2020-01-010000-00-00NoNoCurrent