FDA.reportPublic FDA data

ATORVASTATIN CALCIUM

Product NDC
72162-1712
11-digit product format
721621712
Labeler code
72162
Product ID
72162-1712_4248cd91-df0b-4d84-99c1-a237392848c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATORVASTATIN CALCIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090548
Marketing category
ANDA
Marketing start
2012-05-29
Substance
ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE
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 PROPYLENE GLYCOL SOLVATE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYRZ789OWMI
Rxcui617310

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fa898d56-9495-d6f0-309b-68a5d8e3914aProduct name420260305
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
d25cba4b-d79e-4890-8837-1382f7d09489Product name120231002
91774e91-b249-45e3-8ff8-4b5db2927a69Product name120230718
03fb3cda-d60a-4873-94e9-6fa77cfb1a1cProduct name120220302
34152997-af0b-acf4-dcaf-37211afe8ca4Product name920210312
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
46fdf265-6d5a-1bfb-93db-d82a4ea8aa81Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-1712-2ATORVASTATIN CALCIUM9 in 1 BOTTLETABLET, FILM COATED9102
72162-1712-3ATORVASTATIN CALCIUM30 in 1 BOTTLETABLET, FILM COATED30102
72162-1712-4ATORVASTATIN CALCIUM28 in 1 BOTTLETABLET, FILM COATED28102
72162-1712-6ATORVASTATIN CALCIUM60 in 1 BOTTLETABLET, FILM COATED60102
72162-1712-7ATORVASTATIN CALCIUM20 in 1 BOTTLETABLET, FILM COATED20102
72162-1712-9ATORVASTATIN CALCIUM90 in 1 BOTTLETABLET, FILM COATED90102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1712-2EA - Each72162-1712fe9a69b7-9ab3-4345-8cd9-2c3ecc6e4f3512023-10-16
72162-1712-3EA - Each72162-17129d2c571c-e0e5-4f57-8c74-35383cc440cc12023-10-16
72162-1712-4EA - Each72162-17121596fb85-7714-4fb9-844e-f8ef23e4e53612023-10-16
72162-1712-6EA - Each72162-1712842bdeec-e364-4d49-a9ce-ad8dd91b314912023-10-16
72162-1712-7EA - Each72162-1712ef086d47-6c3d-4e41-970f-6e5f5a4883a012023-10-16
72162-1712-9EA - Each72162-17125962f9f3-e31a-43a4-ad2d-5d5d8b08483512023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1712ATORVASTATIN CALCIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]102Current NDC, 6 package rows20240730_6c1e9bf3-ef52-4053-933d-5a5f7405e642.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617310atorvastatin calcium 20 MG Oral TabletPSN6c1e9bf3-ef52-4053-933d-5a5f7405e642102
617310atorvastatin 20 MG Oral TabletSCD6c1e9bf3-ef52-4053-933d-5a5f7405e642102
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY6c1e9bf3-ef52-4053-933d-5a5f7405e642102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-1712-2721621712029 TABLET, FILM COATED in 1 BOTTLE (72162-1712-2) 2024-07-17NoNoCurrent
72162-1712-37216217120330 TABLET, FILM COATED in 1 BOTTLE (72162-1712-3) 2024-07-17NoNoCurrent
72162-1712-47216217120428 TABLET, FILM COATED in 1 BOTTLE (72162-1712-4) 2024-07-17NoNoCurrent
72162-1712-67216217120660 TABLET, FILM COATED in 1 BOTTLE (72162-1712-6) 2024-07-17NoNoCurrent
72162-1712-77216217120720 TABLET, FILM COATED in 1 BOTTLE (72162-1712-7) 2024-07-17NoNoCurrent
72162-1712-97216217120990 TABLET, FILM COATED in 1 BOTTLE (72162-1712-9) 2024-07-17NoNoCurrent