FDA.reportPublic FDA data

Atorvastatin calcium

Product NDC
72205-022
11-digit product format
722050022
Labeler code
72205
Product ID
72205-022_11823aa6-547f-4c0b-983a-65b837f94e89
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA211933
Marketing category
ANDA
Marketing start
2019-02-08
Substance
ATORVASTATIN CALCIUM TRIHYDRATE
Active strength
10 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 TRIHYDRATE10 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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
d25cba4b-d79e-4890-8837-1382f7d09489Product name120231002
91774e91-b249-45e3-8ff8-4b5db2927a69Product name120230718
03fb3cda-d60a-4873-94e9-6fa77cfb1a1cProduct name120220302
34152997-af0b-acf4-dcaf-37211afe8ca4Product name920210312
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
46fdf265-6d5a-1bfb-93db-d82a4ea8aa81Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72205-022-05Atorvastatin calcium500 in 1 BOTTLETABLET, FILM COATED5007
72205-022-30Atorvastatin calcium30 in 1 BOTTLETABLET, FILM COATED307
72205-022-90Atorvastatin calcium90 in 1 BOTTLETABLET, FILM COATED907
72205-022-99Atorvastatin calcium1000 in 1 BOTTLETABLET, FILM COATED10007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-022-05EA - Each72205-02252577809-fc8f-481d-b1e6-e6f9d7ac39c612019-06-19
72205-022-90EA - Each72205-022914a34aa-7235-4379-b8d3-facf294a0c9c12019-06-19
72205-022-99EA - Each72205-0222592add7-a2c9-4b12-918c-dc0cbd98ad2612022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-022ATORVASTATIN CALCIUM TABLET, FILM COATED [NOVADOZ PHARMACEUTICALS LLC]7Current NDC, Legacy NDC, 4 package rows20240614_bc448f40-421c-490f-8c39-fa8135507973.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617312atorvastatin calcium 10 MG Oral TabletPSN4509aa67-06d4-41d1-80b6-c9bd8ad0bf0711
617312atorvastatin 10 MG Oral TabletSCD4509aa67-06d4-41d1-80b6-c9bd8ad0bf0711
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY4509aa67-06d4-41d1-80b6-c9bd8ad0bf0711
617312atorvastatin calcium 10 MG Oral TabletPSN5b3c3043-9af6-48eb-8b10-528e58c88e488
617312atorvastatin 10 MG Oral TabletSCD5b3c3043-9af6-48eb-8b10-528e58c88e488
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY5b3c3043-9af6-48eb-8b10-528e58c88e488
617312atorvastatin calcium 10 MG Oral TabletPSNbc448f40-421c-490f-8c39-fa81355079737
617310atorvastatin calcium 20 MG Oral TabletPSNbc448f40-421c-490f-8c39-fa81355079737
617311atorvastatin calcium 40 MG Oral TabletPSNbc448f40-421c-490f-8c39-fa81355079737
259255atorvastatin calcium 80 MG Oral TabletPSNbc448f40-421c-490f-8c39-fa81355079737
617312atorvastatin 10 MG Oral TabletSCDbc448f40-421c-490f-8c39-fa81355079737
617310atorvastatin 20 MG Oral TabletSCDbc448f40-421c-490f-8c39-fa81355079737
617311atorvastatin 40 MG Oral TabletSCDbc448f40-421c-490f-8c39-fa81355079737
259255atorvastatin 80 MG Oral TabletSCDbc448f40-421c-490f-8c39-fa81355079737
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSYbc448f40-421c-490f-8c39-fa81355079737
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSYbc448f40-421c-490f-8c39-fa81355079737
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSYbc448f40-421c-490f-8c39-fa81355079737
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSYbc448f40-421c-490f-8c39-fa81355079737
617312atorvastatin calcium 10 MG Oral TabletPSN4ff0d618-cde4-49ae-8bcb-98dafc3ecdba1
617312atorvastatin calcium 10 MG Oral TabletPSNec1d1722-d035-4a8b-b3ab-d2d93f2fd4bb1
617312atorvastatin 10 MG Oral TabletSCD4ff0d618-cde4-49ae-8bcb-98dafc3ecdba1
617312atorvastatin 10 MG Oral TabletSCDec1d1722-d035-4a8b-b3ab-d2d93f2fd4bb1
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY4ff0d618-cde4-49ae-8bcb-98dafc3ecdba1
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSYec1d1722-d035-4a8b-b3ab-d2d93f2fd4bb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72205-022-0572205002205500 TABLET, FILM COATED in 1 BOTTLE (72205-022-05) 2019-02-080000-00-00NoNoCurrent
72205-022-307220500223030 TABLET, FILM COATED in 1 BOTTLE (72205-022-30) 2019-02-080000-00-00NoNoCurrent
72205-022-907220500229090 TABLET, FILM COATED in 1 BOTTLE (72205-022-90) 2019-02-080000-00-00NoNoCurrent
72205-022-99722050022991000 TABLET, FILM COATED in 1 BOTTLE (72205-022-99) 2022-03-240000-00-00NoNoCurrent