FDA.reportPublic FDA data

Atorvastatin calcium

Product NDC
70518-3848
11-digit product format
705183848
Labeler code
70518
Product ID
70518-3848_3f8bd7d1-9146-83b0-e063-6394a90aeaa7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin calcium
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA213853
Marketing category
ANDA
Marketing start
2023-08-31
Substance
ATORVASTATIN
Active strength
80 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
ATORVASTATIN80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiA0JWA85V8F
Rxcui259255

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
70518-3848-0Atorvastatin calcium90 in 1 BOTTLE, PLASTICTABLET907
70518-3848-1Atorvastatin calcium30 in 1 BLISTER PACKTABLET307
70518-3848-2Atorvastatin calcium100 in 1 BOTTLE, PLASTICTABLET1007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3848ATORVASTATIN CALCIUM TABLET [REMEDYREPACK INC.]5Current NDC, 3 package rows20250322_6600f22e-d303-4fe3-8212-accd6fb06e62.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
259255atorvastatin calcium 80 MG Oral TabletPSN6600f22e-d303-4fe3-8212-accd6fb06e627
259255atorvastatin 80 MG Oral TabletSCD6600f22e-d303-4fe3-8212-accd6fb06e627
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY6600f22e-d303-4fe3-8212-accd6fb06e627

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-3848-07051838480090 TABLET in 1 BOTTLE, PLASTIC (70518-3848-0) 90 tablet2023-08-31NoNoHistorical
70518-3848-17051838480130 in 1 BLISTER PACKHistorical
70518-3848-270518384802100 TABLET in 1 BOTTLE, PLASTIC (70518-3848-2) 100 tablet2025-03-19NoNoHistorical