FDA.reportPublic FDA data

Atorvastatin calcium

Product NDC
68071-2967
11-digit product format
680712967
Labeler code
68071
Product ID
68071-2967_10abb3fc-2512-255d-e063-6394a90ae0de
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin calcium
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA213853
Marketing category
ANDA
Marketing start
2020-08-26
Substance
ATORVASTATIN
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
ATORVASTATIN20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiA0JWA85V8F
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
68071-2967-3Atorvastatin calcium30 in 1 BOTTLETABLET304
68071-2967-6Atorvastatin calcium60 in 1 BOTTLETABLET604
68071-2967-9Atorvastatin calcium90 in 1 BOTTLETABLET904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2967ATORVASTATIN CALCIUM TABLET [NUCARE PHARMACEUTICALS,INC.]4Current NDC, 3 package rows20240206_f7e8c8d2-b74e-6afd-e053-6394a90af83e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617310atorvastatin calcium 20 MG Oral TabletPSNf7e8c8d2-b74e-6afd-e053-6394a90af83e4
617310atorvastatin 20 MG Oral TabletSCDf7e8c8d2-b74e-6afd-e053-6394a90af83e4
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSYf7e8c8d2-b74e-6afd-e053-6394a90af83e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-2967-36807129670330 TABLET in 1 BOTTLE (68071-2967-3) 30 tablet2023-03-27NoNoCurrent
68071-2967-66807129670660 TABLET in 1 BOTTLE (68071-2967-6) 60 tablet2023-03-27NoNoCurrent
68071-2967-96807129670990 TABLET in 1 BOTTLE (68071-2967-9) 90 tablet2023-03-27NoNoCurrent