FDA.reportPublic FDA data

ATORVASTATIN CALCIUM

Product NDC
71205-247
11-digit product format
712050247
Labeler code
71205
Product ID
71205-247_f4ee26ae-8587-4eea-84bb-8e3751a4c21d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATORVASTATIN CALCIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA207687
Marketing category
ANDA
Marketing start
2018-08-06
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
71205-247-30ATORVASTATIN CALCIUM30 in 1 BOTTLETABLET, FILM COATED304
71205-247-60ATORVASTATIN CALCIUM60 in 1 BOTTLETABLET, FILM COATED604
71205-247-90ATORVASTATIN CALCIUM90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-247ATORVASTATIN CALCIUM TABLET, FILM COATED [PROFICIENT RX LP]4Current NDC, Legacy NDC, 3 package rows20220409_1923c91e-c6dd-4446-aabd-70a0c6aa1a82.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617310atorvastatin calcium 20 MG Oral TabletPSN1923c91e-c6dd-4446-aabd-70a0c6aa1a824
617310atorvastatin 20 MG Oral TabletSCD1923c91e-c6dd-4446-aabd-70a0c6aa1a824
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY1923c91e-c6dd-4446-aabd-70a0c6aa1a824

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-247-307120502473030 TABLET, FILM COATED in 1 BOTTLE (71205-247-30) 2019-04-010000-00-00NoNoCurrent
71205-247-607120502476060 TABLET, FILM COATED in 1 BOTTLE (71205-247-60) 2019-04-010000-00-00NoNoCurrent
71205-247-907120502479090 TABLET, FILM COATED in 1 BOTTLE (71205-247-90) 2019-04-010000-00-00NoNoCurrent