FDA.reportPublic FDA data

Atorvastatin Calcium

Product NDC
71335-1929
11-digit product format
713351929
Labeler code
71335
Product ID
71335-1929_42ba73ef-18fb-46e6-bfdb-8d7b4fb303d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin Calcium
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA204991
Marketing category
ANDA
Marketing start
2020-09-24
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
71335-1929-1Atorvastatin Calcium30 in 1 BOTTLETABLET30103
71335-1929-2Atorvastatin Calcium60 in 1 BOTTLETABLET60103
71335-1929-3Atorvastatin Calcium90 in 1 BOTTLETABLET90103
71335-1929-4Atorvastatin Calcium9 in 1 BOTTLETABLET9103
71335-1929-5Atorvastatin Calcium28 in 1 BOTTLETABLET28103
71335-1929-6Atorvastatin Calcium20 in 1 BOTTLETABLET20103
71335-1929-7Atorvastatin Calcium180 in 1 BOTTLETABLET180103
71335-1929-8Atorvastatin Calcium100 in 1 BOTTLETABLET100103
71335-1929-9Atorvastatin Calcium7 in 1 BOTTLETABLET7103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1929ATORVASTATIN CALCIUM TABLET [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 9 package rows20240509_5868d3c2-ae17-4a7e-9580-7c3cf9bf009e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617310atorvastatin calcium 20 MG Oral TabletPSN5868d3c2-ae17-4a7e-9580-7c3cf9bf009e103
617310atorvastatin 20 MG Oral TabletSCD5868d3c2-ae17-4a7e-9580-7c3cf9bf009e103
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY5868d3c2-ae17-4a7e-9580-7c3cf9bf009e103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1929-17133519290130 TABLET in 1 BOTTLE (71335-1929-1) 30 tablet2021-08-250000-00-00NoNoCurrent
71335-1929-27133519290260 TABLET in 1 BOTTLE (71335-1929-2) 60 tablet2021-08-250000-00-00NoNoCurrent
71335-1929-37133519290390 TABLET in 1 BOTTLE (71335-1929-3) 90 tablet2021-08-250000-00-00NoNoCurrent
71335-1929-4713351929049 TABLET in 1 BOTTLE (71335-1929-4) 9 tablet2021-08-250000-00-00NoNoCurrent
71335-1929-57133519290528 TABLET in 1 BOTTLE (71335-1929-5) 28 tablet2021-08-250000-00-00NoNoCurrent
71335-1929-67133519290620 TABLET in 1 BOTTLE (71335-1929-6) 20 tablet2021-08-250000-00-00NoNoCurrent
71335-1929-771335192907180 TABLET in 1 BOTTLE (71335-1929-7) 180 tablet2021-08-250000-00-00NoNoCurrent
71335-1929-871335192908100 TABLET in 1 BOTTLE (71335-1929-8) 100 tablet2024-04-05NoNoCurrent
71335-1929-9713351929097 TABLET in 1 BOTTLE (71335-1929-9) 7 tablet2024-04-05NoNoCurrent