FDA.reportPublic FDA data

Atorvastatin calcium

Product NDC
70518-4422
11-digit product format
705184422
Labeler code
70518
Product ID
70518-4422_4d4b567c-0922-39bc-e063-6394a90a4df6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA217081
Marketing category
ANDA
Marketing start
2025-08-04
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
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 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
70518-4422-0Atorvastatin calcium100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1004
70518-4422-1Atorvastatin calcium30 in 1 BLISTER PACKTABLET, FILM COATED304
70518-4422-2Atorvastatin calcium90 in 1 BOTTLE, PLASTICTABLET, FILM COATED904
70518-4422-3Atorvastatin calcium30 in 1 BLISTER PACKTABLET, FILM COATED304

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617312atorvastatin calcium 10 MG Oral TabletPSNf7bb4aac-f716-4dd9-a6d7-6f37e865b8434
617312atorvastatin 10 MG Oral TabletSCDf7bb4aac-f716-4dd9-a6d7-6f37e865b8434
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSYf7bb4aac-f716-4dd9-a6d7-6f37e865b8434

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-4422-070518442200100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4422-0) 2025-08-04NoNoHistorical
70518-4422-17051844220130 TABLET, FILM COATED in 1 BLISTER PACK (70518-4422-1) 2025-08-21NoNoHistorical
70518-4422-27051844220290 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4422-2) 2025-09-10NoNoHistorical
70518-4422-37051844220330 TABLET, FILM COATED in 1 BLISTER PACK (70518-4422-3) 2026-03-17NoNoHistorical