FDA.reportPublic FDA data

Atorvastatin calcium

Product NDC
70518-3783
11-digit product format
705183783
Labeler code
70518
Product ID
70518-3783_3f6530fd-c3b6-70f9-e063-6394a90ad2fe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin calcium
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA213853
Marketing category
ANDA
Marketing start
2023-07-11
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
70518-3783-0Atorvastatin calcium30 in 1 BLISTER PACKTABLET307
70518-3783-1Atorvastatin calcium90 in 1 BOTTLE, PLASTICTABLET907
70518-3783-2Atorvastatin calcium30 in 1 BOTTLE, PLASTICTABLET307
70518-3783-3Atorvastatin calcium100 in 1 BOTTLE, PLASTICTABLET1007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3783ATORVASTATIN CALCIUM TABLET [REMEDYREPACK INC.]5Current NDC, 4 package rows20250523_8821431a-c387-4b75-9540-f92bd455e961.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617310atorvastatin calcium 20 MG Oral TabletPSN8821431a-c387-4b75-9540-f92bd455e9617
617310atorvastatin 20 MG Oral TabletSCD8821431a-c387-4b75-9540-f92bd455e9617
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY8821431a-c387-4b75-9540-f92bd455e9617

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-3783-07051837830030 in 1 BLISTER PACKHistorical
70518-3783-17051837830190 TABLET in 1 BOTTLE, PLASTIC (70518-3783-1) 90 tablet2023-08-26NoNoHistorical
70518-3783-27051837830230 TABLET in 1 BOTTLE, PLASTIC (70518-3783-2) 30 tablet2024-07-11NoNoHistorical
70518-3783-370518378303100 TABLET in 1 BOTTLE, PLASTIC (70518-3783-3) 100 tablet2025-05-13NoNoHistorical