FDA.reportPublic FDA data

ATORVASTATIN CALCIUM

Product NDC
16729-046
11-digit product format
167290046
Labeler code
16729
Product ID
16729-046_40828d2e-69eb-5d38-e063-6394a90abd70
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATORVASTATIN CALCIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Accord Healthcare Inc.
Application
ANDA207687
Marketing category
ANDA
Marketing start
2018-08-06
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
16729-046-01ATORVASTATIN CALCIUM100 in 1 BOTTLETABLET, FILM COATED10013
16729-046-10ATORVASTATIN CALCIUM30 in 1 BOTTLETABLET, FILM COATED3013
16729-046-15ATORVASTATIN CALCIUM90 in 1 BOTTLETABLET, FILM COATED9013
16729-046-16ATORVASTATIN CALCIUM500 in 1 BOTTLETABLET, FILM COATED50013
16729-046-17ATORVASTATIN CALCIUM1000 in 1 BOTTLETABLET, FILM COATED100013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-046-15EA - Each16729-0469510bf36-36f2-425a-a582-0e0b3a1e491312021-06-02
16729-046-17EA - Each16729-04680d7a5dc-522c-4d32-9aea-ba0582e36af412018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-046ATORVASTATIN CALCIUM TABLET, FILM COATED [ACCORD HEALTHCARE INC.]12Current NDC, Legacy NDC, 5 package rows20241004_4e06b20d-cc5d-46eb-991b-5972248de3af.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617312atorvastatin calcium 10 MG Oral TabletPSN4e06b20d-cc5d-46eb-991b-5972248de3af13
617310atorvastatin calcium 20 MG Oral TabletPSN4e06b20d-cc5d-46eb-991b-5972248de3af13
617311atorvastatin calcium 40 MG Oral TabletPSN4e06b20d-cc5d-46eb-991b-5972248de3af13
259255atorvastatin calcium 80 MG Oral TabletPSN4e06b20d-cc5d-46eb-991b-5972248de3af13
617312atorvastatin 10 MG Oral TabletSCD4e06b20d-cc5d-46eb-991b-5972248de3af13
617310atorvastatin 20 MG Oral TabletSCD4e06b20d-cc5d-46eb-991b-5972248de3af13
617311atorvastatin 40 MG Oral TabletSCD4e06b20d-cc5d-46eb-991b-5972248de3af13
259255atorvastatin 80 MG Oral TabletSCD4e06b20d-cc5d-46eb-991b-5972248de3af13
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY4e06b20d-cc5d-46eb-991b-5972248de3af13
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY4e06b20d-cc5d-46eb-991b-5972248de3af13
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY4e06b20d-cc5d-46eb-991b-5972248de3af13
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY4e06b20d-cc5d-46eb-991b-5972248de3af13
617311atorvastatin calcium 40 MG Oral TabletPSN1fb2d51e-360c-40a3-8072-f22893890a517
617311atorvastatin 40 MG Oral TabletSCD1fb2d51e-360c-40a3-8072-f22893890a517
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY1fb2d51e-360c-40a3-8072-f22893890a517
617311atorvastatin calcium 40 MG Oral TabletPSN6f63426a-6a79-4a8a-97b7-8fc86b3400413
617311atorvastatin calcium 40 MG Oral TabletPSNa0732bc4-702d-f566-e053-2a95a90a1d693
617311atorvastatin 40 MG Oral TabletSCD6f63426a-6a79-4a8a-97b7-8fc86b3400413
617311atorvastatin 40 MG Oral TabletSCDa0732bc4-702d-f566-e053-2a95a90a1d693
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY6f63426a-6a79-4a8a-97b7-8fc86b3400413
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSYa0732bc4-702d-f566-e053-2a95a90a1d693
617311atorvastatin calcium 40 MG Oral TabletPSNa1b22973-cb9a-473e-a240-112b3e84e97c1
617311atorvastatin calcium 40 MG Oral TabletPSNddbae5eb-8f2c-7bb1-e053-2995a90a4b951
617311atorvastatin 40 MG Oral TabletSCDa1b22973-cb9a-473e-a240-112b3e84e97c1
617311atorvastatin 40 MG Oral TabletSCDddbae5eb-8f2c-7bb1-e053-2995a90a4b951
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSYa1b22973-cb9a-473e-a240-112b3e84e97c1
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSYddbae5eb-8f2c-7bb1-e053-2995a90a4b951

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16729-046-0116729004601100 in 1 BOTTLEHistorical
16729-046-101672900461030 in 1 BOTTLEHistorical
16729-046-151672900461590 TABLET, FILM COATED in 1 BOTTLE (16729-046-15) 2021-07-130000-00-00NoNoCurrent
16729-046-1616729004616500 in 1 BOTTLEHistorical
16729-046-17167290046171000 TABLET, FILM COATED in 1 BOTTLE (16729-046-17) 2018-08-060000-00-00NoNoCurrent