FDA.reportPublic FDA data

Atorvastatin Calcium

Product NDC
71205-098
11-digit product format
712050098
Labeler code
71205
Product ID
71205-098_79466114-113a-472d-bfee-271cf74258ab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA205300
Marketing category
ANDA
Marketing start
2017-05-04
Substance
ATORVASTATIN CALCIUM TRIHYDRATE
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
ATORVASTATIN CALCIUM TRIHYDRATE80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii48A5M73Z4Q
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
71205-098-30Atorvastatin Calcium30 in 1 BOTTLETABLET, FILM COATED303
71205-098-60Atorvastatin Calcium60 in 1 BOTTLETABLET, FILM COATED603
71205-098-90Atorvastatin Calcium90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-098-90EA - Each71205-098f0a89414-dc8c-49bb-b62f-095a841f05b812018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-098ATORVASTATIN CALCIUM TABLET, FILM COATED [PROFICIENT RX LP]3Current NDC, Legacy NDC, 3 package rows20191029_bd56a76b-5570-46a7-9399-fc110d913bf9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
259255atorvastatin calcium 80 MG Oral TabletPSNbd56a76b-5570-46a7-9399-fc110d913bf93
259255atorvastatin 80 MG Oral TabletSCDbd56a76b-5570-46a7-9399-fc110d913bf93
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSYbd56a76b-5570-46a7-9399-fc110d913bf93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-098-307120500983030 TABLET, FILM COATED in 1 BOTTLE (71205-098-30) 2018-09-040000-00-00NoNoCurrent
71205-098-607120500986060 TABLET, FILM COATED in 1 BOTTLE (71205-098-60) 2018-09-040000-00-00NoNoCurrent
71205-098-907120500989090 TABLET, FILM COATED in 1 BOTTLE (71205-098-90) 2018-09-040000-00-00NoNoCurrent