FDA.reportPublic FDA data

ATORVASTATIN CALCIUM

Product NDC
71610-036
11-digit product format
716100036
Labeler code
71610
Product ID
71610-036_b294ecc8-3293-48a9-b79f-58ed5969ff43
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATORVASTATIN CALCIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA205519
Marketing category
ANDA
Marketing start
2017-11-16
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
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
d25cba4b-d79e-4890-8837-1382f7d09489Product name120231002
91774e91-b249-45e3-8ff8-4b5db2927a69Product name120230718
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
03fb3cda-d60a-4873-94e9-6fa77cfb1a1cProduct name120220302
34152997-af0b-acf4-dcaf-37211afe8ca4Product name920210312
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
46fdf265-6d5a-1bfb-93db-d82a4ea8aa81Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-036-15ATORVASTATIN CALCIUM15 in 1 BOTTLETABLET, FILM COATED151
71610-036-30ATORVASTATIN CALCIUM30 in 1 BOTTLETABLET, FILM COATED301
71610-036-45ATORVASTATIN CALCIUM45 in 1 BOTTLETABLET, FILM COATED451
71610-036-60ATORVASTATIN CALCIUM90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-036-15EA - Each71610-0369c0022b4-6334-4512-b41a-00d46084f03312018-04-19
71610-036-30EA - Each71610-0364fda813a-e598-4601-bd1e-6e2d6f03ce4012018-04-19
71610-036-45EA - Each71610-03683b8faae-f84f-4091-8e3e-b448e87d581812018-04-19
71610-036-60EA - Each71610-0361cb24b81-078a-474c-bde1-f1374f67e06212018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-036ATORVASTATIN CALCIUM TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 4 package rows20180303_b16b3805-7e60-447c-b3df-7a9392b63c99.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
259255atorvastatin calcium 80 MG Oral TabletPSNb16b3805-7e60-447c-b3df-7a9392b63c991
259255atorvastatin 80 MG Oral TabletSCDb16b3805-7e60-447c-b3df-7a9392b63c991
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSYb16b3805-7e60-447c-b3df-7a9392b63c991

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-036-157161000361515 TABLET, FILM COATED in 1 BOTTLE (71610-036-15) 2018-01-260000-00-00NoNoCurrent
71610-036-307161000363030 TABLET, FILM COATED in 1 BOTTLE (71610-036-30) 2018-01-260000-00-00NoNoCurrent
71610-036-457161000364545 TABLET, FILM COATED in 1 BOTTLE (71610-036-45) 2018-01-260000-00-00NoNoCurrent
71610-036-607161000366090 TABLET, FILM COATED in 1 BOTTLE (71610-036-60) 2018-01-310000-00-00NoNoCurrent