FDA.reportPublic FDA data

Atorvastatin calcium

Product NDC
71335-1336
11-digit product format
713351336
Labeler code
71335
Product ID
71335-1336_05b0f170-ac97-4a83-b03a-659a4b493ee2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA211933
Marketing category
ANDA
Marketing start
2019-02-08
Substance
ATORVASTATIN CALCIUM TRIHYDRATE
Active strength
80 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 TRIHYDRATE80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii48A5M73Z4Q
Rxcui259255

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fa898d56-9495-d6f0-309b-68a5d8e3914aProduct name420260305
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
d25cba4b-d79e-4890-8837-1382f7d09489Product name120231002
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
91774e91-b249-45e3-8ff8-4b5db2927a69Product name120230718
03fb3cda-d60a-4873-94e9-6fa77cfb1a1cProduct name120220302
34152997-af0b-acf4-dcaf-37211afe8ca4Product name920210312
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
46fdf265-6d5a-1bfb-93db-d82a4ea8aa81Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1336-1Atorvastatin calcium30 in 1 BOTTLETABLET, FILM COATED306
71335-1336-2Atorvastatin calcium60 in 1 BOTTLETABLET, FILM COATED606
71335-1336-3Atorvastatin calcium90 in 1 BOTTLETABLET, FILM COATED906
71335-1336-4Atorvastatin calcium180 in 1 BOTTLETABLET, FILM COATED1806

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1336ATORVASTATIN CALCIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 4 package rows20240724_00afce9b-48c9-487a-a738-e359c005c707.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
259255atorvastatin calcium 80 MG Oral TabletPSN00afce9b-48c9-487a-a738-e359c005c7076
259255atorvastatin 80 MG Oral TabletSCD00afce9b-48c9-487a-a738-e359c005c7076
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY00afce9b-48c9-487a-a738-e359c005c7076

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1336-17133513360130 TABLET, FILM COATED in 1 BOTTLE (71335-1336-1) 2020-01-200000-00-00NoNoCurrent
71335-1336-27133513360260 TABLET, FILM COATED in 1 BOTTLE (71335-1336-2) 2024-07-090000-00-00NoNoCurrent
71335-1336-37133513360390 TABLET, FILM COATED in 1 BOTTLE (71335-1336-3) 2019-09-100000-00-00NoNoCurrent
71335-1336-471335133604180 TABLET, FILM COATED in 1 BOTTLE (71335-1336-4) 2024-07-090000-00-00NoNoCurrent