FDA.reportPublic FDA data

Atorvastatin calcium

Product NDC
71335-2213
11-digit product format
713352213
Labeler code
71335
Product ID
71335-2213_5d91c6d3-f7a9-467d-a93e-01fb4b08912e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin calcium
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA213853
Marketing category
ANDA
Marketing start
2020-08-26
Substance
ATORVASTATIN
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
ATORVASTATIN20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiA0JWA85V8F
Rxcui617310

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
71335-2213-1Atorvastatin calcium30 in 1 BOTTLETABLET30105
71335-2213-2Atorvastatin calcium60 in 1 BOTTLETABLET60105
71335-2213-3Atorvastatin calcium90 in 1 BOTTLETABLET90105
71335-2213-4Atorvastatin calcium9 in 1 BOTTLETABLET9105
71335-2213-5Atorvastatin calcium28 in 1 BOTTLETABLET28105
71335-2213-6Atorvastatin calcium20 in 1 BOTTLETABLET20105
71335-2213-7Atorvastatin calcium180 in 1 BOTTLETABLET180105
71335-2213-8Atorvastatin calcium100 in 1 BOTTLETABLET100105
71335-2213-9Atorvastatin calcium7 in 1 BOTTLETABLET7105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2213ATORVASTATIN CALCIUM TABLET [BRYANT RANCH PREPACK]104Current NDC, 9 package rows20250228_71cd9b85-4914-4b0b-97db-7aaf25983211.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617310atorvastatin calcium 20 MG Oral TabletPSN71cd9b85-4914-4b0b-97db-7aaf25983211105
617310atorvastatin 20 MG Oral TabletSCD71cd9b85-4914-4b0b-97db-7aaf25983211105
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY71cd9b85-4914-4b0b-97db-7aaf25983211105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2213-17133522130130 TABLET in 1 BOTTLE (71335-2213-1) 30 tablet2023-09-06NoNoHistorical
71335-2213-27133522130260 TABLET in 1 BOTTLE (71335-2213-2) 60 tablet2024-01-26NoNoHistorical
71335-2213-37133522130390 TABLET in 1 BOTTLE (71335-2213-3) 90 tablet2023-08-04NoNoHistorical
71335-2213-4713352213049 TABLET in 1 BOTTLE (71335-2213-4) 9 tablet2025-01-31NoNoHistorical
71335-2213-57133522130528 TABLET in 1 BOTTLE (71335-2213-5) 28 tablet2025-01-31NoNoHistorical
71335-2213-67133522130620 TABLET in 1 BOTTLE (71335-2213-6) 20 tablet2025-01-31NoNoHistorical
71335-2213-771335221307180 TABLET in 1 BOTTLE (71335-2213-7) 180 tablet2023-10-19NoNoHistorical
71335-2213-871335221308100 TABLET in 1 BOTTLE (71335-2213-8) 100 tablet2025-01-31NoNoHistorical
71335-2213-9713352213097 TABLET in 1 BOTTLE (71335-2213-9) 7 tablet2025-01-31NoNoHistorical