FDA.reportPublic FDA data

Atorvastatin Calcium

Product NDC
70518-3037
11-digit product format
705183037
Labeler code
70518
Product ID
70518-3037_4ab4bba0-b4e9-19a9-e063-6294a90a9df5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA209288
Marketing category
ANDA
Marketing start
2021-03-03
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Atorvastatin Calcium
Listing expiration
2027-12-31

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
70518-3037-0Atorvastatin Calcium30 in 1 BLISTER PACKTABLET, FILM COATED309
70518-3037-1Atorvastatin Calcium30 in 1 BLISTER PACKTABLET, FILM COATED309
70518-3037-2Atorvastatin Calcium100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3037ATORVASTATIN CALCIUM TABLET, FILM COATED [REMEDYREPACK INC.]7Current NDC, Legacy NDC, 3 package rows20250322_09cb8375-075c-47e8-a4eb-8ac667ed849e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617310atorvastatin calcium 20 MG Oral TabletPSN09cb8375-075c-47e8-a4eb-8ac667ed849e9
617310atorvastatin 20 MG Oral TabletSCD09cb8375-075c-47e8-a4eb-8ac667ed849e9
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY09cb8375-075c-47e8-a4eb-8ac667ed849e9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-3037-07051830370030 TABLET, FILM COATED in 1 BLISTER PACK (70518-3037-0) 2021-03-030000-00-00NoNoCurrent
70518-3037-17051830370130 in 1 BLISTER PACKHistorical
70518-3037-270518303702100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3037-2) 2025-03-19NoNoHistorical