Atorvastatin Calcium

Product NDC
71335-1010
11-digit product format
713351010
Labeler code
71335
Product ID
71335-1010_b74ba5ea-e623-4044-a17e-e16428125e73
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076477
Marketing category
ANDA
Marketing start
2011-12-01
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
71335-1010-1Atorvastatin Calcium30 in 1 BOTTLETABLET, FILM COATED3013
71335-1010-2Atorvastatin Calcium60 in 1 BOTTLETABLET, FILM COATED6013
71335-1010-3Atorvastatin Calcium90 in 1 BOTTLETABLET, FILM COATED9013
71335-1010-4Atorvastatin Calcium9 in 1 BOTTLETABLET, FILM COATED913
71335-1010-5Atorvastatin Calcium28 in 1 BOTTLETABLET, FILM COATED2813
71335-1010-6Atorvastatin Calcium20 in 1 BOTTLETABLET, FILM COATED2013
71335-1010-7Atorvastatin Calcium180 in 1 BOTTLETABLET, FILM COATED18013
71335-1010-8Atorvastatin Calcium100 in 1 BOTTLETABLET, FILM COATED10013
71335-1010-9Atorvastatin Calcium7 in 1 BOTTLETABLET, FILM COATED713

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1010-1EA - Each71335-1010280f2acd-fbe8-4dd5-9186-f47c52c512f912020-09-14
71335-1010-3EA - Each71335-1010cc19ee05-ab01-458b-8b42-9d683be679bc12020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1010ATORVASTATIN CALCIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]13Current NDC, Legacy NDC, 9 package rows20240601_bbb1a527-3b4d-4fd4-9e38-b231ad5d6d8f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617310atorvastatin calcium 20 MG Oral TabletPSNbbb1a527-3b4d-4fd4-9e38-b231ad5d6d8f13
617310atorvastatin 20 MG Oral TabletSCDbbb1a527-3b4d-4fd4-9e38-b231ad5d6d8f13
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSYbbb1a527-3b4d-4fd4-9e38-b231ad5d6d8f13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1010-17133510100130 TABLET, FILM COATED in 1 BOTTLE (71335-1010-1) 2018-11-290000-00-00NoNoCurrent
71335-1010-27133510100260 TABLET, FILM COATED in 1 BOTTLE (71335-1010-2) 2021-06-170000-00-00NoNoCurrent
71335-1010-37133510100390 TABLET, FILM COATED in 1 BOTTLE (71335-1010-3) 2018-11-190000-00-00NoNoCurrent
71335-1010-4713351010049 TABLET, FILM COATED in 1 BOTTLE (71335-1010-4) 2024-05-300000-00-00NoNoCurrent
71335-1010-57133510100528 TABLET, FILM COATED in 1 BOTTLE (71335-1010-5) 2024-05-300000-00-00NoNoCurrent
71335-1010-67133510100620 TABLET, FILM COATED in 1 BOTTLE (71335-1010-6) 2024-05-300000-00-00NoNoCurrent
71335-1010-771335101007180 TABLET, FILM COATED in 1 BOTTLE (71335-1010-7) 2024-05-300000-00-00NoNoCurrent
71335-1010-871335101008100 TABLET, FILM COATED in 1 BOTTLE (71335-1010-8) 2024-05-300000-00-00NoNoCurrent
71335-1010-9713351010097 TABLET, FILM COATED in 1 BOTTLE (71335-1010-9) 2024-05-30NoNoHistorical