FDA.reportPublic FDA data

Atorvastatin calcium

Product NDC
70518-3339
11-digit product format
705183339
Labeler code
70518
Product ID
70518-3339_4ef3281a-e577-b5c2-e063-6394a90ad3f1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA211933
Marketing category
ANDA
Marketing start
2022-01-23
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
d25cba4b-d79e-4890-8837-1382f7d09489Product name120231002
91774e91-b249-45e3-8ff8-4b5db2927a69Product name120230718
03fb3cda-d60a-4873-94e9-6fa77cfb1a1cProduct name120220302
34152997-af0b-acf4-dcaf-37211afe8ca4Product name920210312
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
46fdf265-6d5a-1bfb-93db-d82a4ea8aa81Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3339-0Atorvastatin calcium30 in 1 BLISTER PACKTABLET, FILM COATED307
70518-3339-1Atorvastatin calcium30 in 1 BLISTER PACKTABLET, FILM COATED307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3339ATORVASTATIN CALCIUM TABLET, FILM COATED [REMEDYREPACK INC.]5Current NDC, Legacy NDC, 2 package rows20241004_b0bbab86-6789-4ffb-8f84-ee91b69fdb34.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617310atorvastatin calcium 20 MG Oral TabletPSNb0bbab86-6789-4ffb-8f84-ee91b69fdb347
617310atorvastatin 20 MG Oral TabletSCDb0bbab86-6789-4ffb-8f84-ee91b69fdb347
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSYb0bbab86-6789-4ffb-8f84-ee91b69fdb347

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-3339-07051833390030 TABLET, FILM COATED in 1 BLISTER PACK (70518-3339-0) 2022-01-230000-00-00NoNoCurrent
70518-3339-17051833390130 TABLET, FILM COATED in 1 BLISTER PACK (70518-3339-1) 2023-12-19NoNoHistorical