FDA.reportPublic FDA data

Atorvastatin Calcium

Product NDC
70518-4138
11-digit product format
705184138
Labeler code
70518
Product ID
70518-4138_3fb3b563-4bba-0322-e063-6394a90a238d
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
2024-07-10
Substance
ATORVASTATIN CALCIUM TRIHYDRATE
Active strength
10 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 TRIHYDRATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii48A5M73Z4Q
Rxcui617312

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
70518-4138-0Atorvastatin Calcium90 in 1 BOTTLE, PLASTICTABLET, FILM COATED905
70518-4138-1Atorvastatin Calcium100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4138ATORVASTATIN CALCIUM TABLET, FILM COATED [REMEDYREPACK INC.]4Current NDC, 2 package rows20250322_57f9b462-f08e-483c-9b64-b7e4c8d46927.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617312atorvastatin calcium 10 MG Oral TabletPSN57f9b462-f08e-483c-9b64-b7e4c8d469275
617312atorvastatin 10 MG Oral TabletSCD57f9b462-f08e-483c-9b64-b7e4c8d469275
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY57f9b462-f08e-483c-9b64-b7e4c8d469275

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-4138-07051841380090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4138-0) 2024-07-10NoNoCurrent
70518-4138-170518413801100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4138-1) 2025-03-19NoNoCurrent