FDA.reportPublic FDA data

ATORVASTATIN CALCIUM

Product NDC
68071-3714
11-digit product format
680713714
Labeler code
68071
Product ID
68071-3714_373efe2d-f2c0-ad83-e063-6294a90accef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATORVASTATIN CALCIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA214344
Marketing category
ANDA
Marketing start
2023-09-12
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
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
68071-3714-3ATORVASTATIN CALCIUM30 in 1 BOTTLETABLET, FILM COATED304
68071-3714-6ATORVASTATIN CALCIUM60 in 1 BOTTLETABLET, FILM COATED604
68071-3714-9ATORVASTATIN CALCIUM90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3714ATORVASTATIN CALCIUM TABLET, FILM COATED [NUCARE PHARMACEUTICALS, INC.]3Current NDC, 3 package rows20250202_258d8737-0b80-7d80-e063-6394a90adc8e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617310atorvastatin calcium 20 MG Oral TabletPSN258d8737-0b80-7d80-e063-6394a90adc8e4
617310atorvastatin 20 MG Oral TabletSCD258d8737-0b80-7d80-e063-6394a90adc8e4
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY258d8737-0b80-7d80-e063-6394a90adc8e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68071-3714-36807137140330 TABLET, FILM COATED in 1 BOTTLE (68071-3714-3) 2024-10-28NoNoCurrent
68071-3714-66807137140660 TABLET, FILM COATED in 1 BOTTLE (68071-3714-6) 2024-11-20NoNoCurrent
68071-3714-96807137140990 TABLET, FILM COATED in 1 BOTTLE (68071-3714-9) 2025-01-31NoNoCurrent