FDA.reportPublic FDA data

ATORVASTATIN CALCIUM

Product NDC
71205-246
11-digit product format
712050246
Labeler code
71205
Product ID
71205-246_8515db73-8e51-4ff6-b0ae-925490fb815d
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
2018-08-02
Substance
ATORVASTATIN CALCIUM TRIHYDRATE
Active strength
10 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 TRIHYDRATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii48A5M73Z4Q
Rxcui617312

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
71205-246-30ATORVASTATIN CALCIUM30 in 1 BOTTLETABLET, FILM COATED304
71205-246-60ATORVASTATIN CALCIUM60 in 1 BOTTLETABLET, FILM COATED604
71205-246-90ATORVASTATIN CALCIUM90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-246-30EA - Each71205-246466d09ff-03fa-4318-983c-8b8ecfc9db9712019-08-06
71205-246-90EA - Each71205-246604b6001-5af7-4da3-9928-2e8d519d377a12019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-246ATORVASTATIN CALCIUM TABLET, FILM COATED [PROFICIENT RX LP]4Current NDC, Legacy NDC, 3 package rows20220602_e931003a-3a8d-48b9-b13f-e620017303f6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617312atorvastatin calcium 10 MG Oral TabletPSNe931003a-3a8d-48b9-b13f-e620017303f64
617312atorvastatin 10 MG Oral TabletSCDe931003a-3a8d-48b9-b13f-e620017303f64
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSYe931003a-3a8d-48b9-b13f-e620017303f64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-246-307120502463030 TABLET, FILM COATED in 1 BOTTLE (71205-246-30) 2019-04-010000-00-00NoNoCurrent
71205-246-607120502466060 TABLET, FILM COATED in 1 BOTTLE (71205-246-60) 2019-04-010000-00-00NoNoCurrent
71205-246-907120502469090 TABLET, FILM COATED in 1 BOTTLE (71205-246-90) 2019-04-010000-00-00NoNoCurrent