FDA.reportPublic FDA data

Atorvastatin Calcium

Product NDC
50090-6061
11-digit product format
500906061
Labeler code
50090
Product ID
50090-6061_9718196e-47d1-410e-8038-e5a8db1ebaaa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA209288
Marketing category
ANDA
Marketing start
2018-12-23
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
50090-6061-0Atorvastatin Calcium30 in 1 BOTTLETABLET, FILM COATED306
50090-6061-1Atorvastatin Calcium90 in 1 BOTTLETABLET, FILM COATED906
50090-6061-2Atorvastatin Calcium100 in 1 BOTTLETABLET, FILM COATED1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6061-0EA - Each50090-60612801bb75-6519-4952-80a5-bda2313530cb12022-10-06
50090-6061-1EA - Each50090-6061d12087d3-a539-40fa-93e0-b2aafe69d0ed12022-10-06
50090-6061-2EA - Each50090-60613ec21ed2-b152-480b-bbcf-029abf215a0f12023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6061ATORVASTATIN CALCIUM TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]6Current NDC, Legacy NDC, 3 package rows20240417_e52b4b11-9618-4787-ae67-44e4a3166dfb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
259255atorvastatin calcium 80 MG Oral TabletPSNe52b4b11-9618-4787-ae67-44e4a3166dfb6
259255atorvastatin 80 MG Oral TabletSCDe52b4b11-9618-4787-ae67-44e4a3166dfb6
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSYe52b4b11-9618-4787-ae67-44e4a3166dfb6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-6061-05009060610030 TABLET, FILM COATED in 1 BOTTLE (50090-6061-0) 2022-08-260000-00-00NoNoCurrent
50090-6061-15009060610190 TABLET, FILM COATED in 1 BOTTLE (50090-6061-1) 2022-08-260000-00-00NoNoCurrent
50090-6061-250090606102100 TABLET, FILM COATED in 1 BOTTLE (50090-6061-2) 2023-03-07NoNoCurrent