FDA.reportPublic FDA data

Atorvastatin calcium

Product NDC
71205-765
11-digit product format
712050765
Labeler code
71205
Product ID
71205-765_514fcba1-713c-4aeb-be8c-369fcf9b4ffe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA211933
Marketing category
ANDA
Marketing start
2019-02-08
Substance
ATORVASTATIN CALCIUM TRIHYDRATE
Active strength
40 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 TRIHYDRATE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii48A5M73Z4Q
Rxcui617311

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
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
71205-765-30Atorvastatin calcium30 in 1 BOTTLETABLET, FILM COATED301
71205-765-60Atorvastatin calcium60 in 1 BOTTLETABLET, FILM COATED601
71205-765-90Atorvastatin calcium90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-765-30EA - Each71205-76508736ba1-fd29-464b-9c8c-6d8d632ab13f12023-04-07
71205-765-90EA - Each71205-765f4e361dd-2550-4b6d-9478-d943d126536912024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-765ATORVASTATIN CALCIUM TABLET, FILM COATED [PROFICIENT RX LP]1Current NDC, 3 package rows20230222_514fcba1-713c-4aeb-be8c-369fcf9b4ffe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617311atorvastatin calcium 40 MG Oral TabletPSN514fcba1-713c-4aeb-be8c-369fcf9b4ffe1
617311atorvastatin 40 MG Oral TabletSCD514fcba1-713c-4aeb-be8c-369fcf9b4ffe1
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY514fcba1-713c-4aeb-be8c-369fcf9b4ffe1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71205-765-307120507653030 TABLET, FILM COATED in 1 BOTTLE (71205-765-30) 2023-02-15NoNoCurrent
71205-765-607120507656060 TABLET, FILM COATED in 1 BOTTLE (71205-765-60) 2023-02-15NoNoCurrent
71205-765-907120507659090 TABLET, FILM COATED in 1 BOTTLE (71205-765-90) 2023-02-15NoNoCurrent