FDA.reportPublic FDA data

Atorvastatin Calcium

Product NDC
71335-2393
11-digit product format
713352393
Labeler code
71335
Product ID
71335-2393_d8d1f748-70a7-4ded-87ec-a2ef602cd5e6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin Calcium
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA214659
Marketing category
ANDA
Marketing start
2022-08-29
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
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
71335-2393-1Atorvastatin Calcium30 in 1 BOTTLETABLET302
71335-2393-2Atorvastatin Calcium60 in 1 BOTTLETABLET602
71335-2393-3Atorvastatin Calcium90 in 1 BOTTLETABLET902
71335-2393-4Atorvastatin Calcium9 in 1 BOTTLETABLET92
71335-2393-5Atorvastatin Calcium28 in 1 BOTTLETABLET282
71335-2393-6Atorvastatin Calcium20 in 1 BOTTLETABLET202
71335-2393-7Atorvastatin Calcium180 in 1 BOTTLETABLET1802
71335-2393-8Atorvastatin Calcium100 in 1 BOTTLETABLET1002
71335-2393-9Atorvastatin Calcium7 in 1 BOTTLETABLET72

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2393ATORVASTATIN CALCIUM TABLET [BRYANT RANCH PREPACK]1Current NDC, 9 package rows20240531_a33838d7-4e5e-4079-9d3d-00c2048cf776.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617310atorvastatin calcium 20 MG Oral TabletPSNa33838d7-4e5e-4079-9d3d-00c2048cf7762
617310atorvastatin 20 MG Oral TabletSCDa33838d7-4e5e-4079-9d3d-00c2048cf7762
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSYa33838d7-4e5e-4079-9d3d-00c2048cf7762

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2393-17133523930130 TABLET in 1 BOTTLE (71335-2393-1) 30 tablet2024-05-29NoNoHistorical
71335-2393-27133523930260 TABLET in 1 BOTTLE (71335-2393-2) 60 tablet2024-05-29NoNoHistorical
71335-2393-37133523930390 TABLET in 1 BOTTLE (71335-2393-3) 90 tablet2024-05-29NoNoHistorical
71335-2393-4713352393049 TABLET in 1 BOTTLE (71335-2393-4) 9 tablet2024-05-29NoNoHistorical
71335-2393-57133523930528 TABLET in 1 BOTTLE (71335-2393-5) 28 tablet2024-05-29NoNoHistorical
71335-2393-67133523930620 TABLET in 1 BOTTLE (71335-2393-6) 20 tablet2024-05-29NoNoHistorical
71335-2393-771335239307180 TABLET in 1 BOTTLE (71335-2393-7) 180 tablet2024-05-29NoNoHistorical
71335-2393-871335239308100 TABLET in 1 BOTTLE (71335-2393-8) 100 tablet2024-05-29NoNoHistorical
71335-2393-9713352393097 TABLET in 1 BOTTLE (71335-2393-9) 7 tablet2024-05-29NoNoHistorical