atorvastatin calcium

Product NDC
50090-7720
11-digit product format
500907720
Labeler code
50090
Product ID
50090-7720_18864d9f-cd9f-40a0-9fc7-3d32a4bdf690
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
atorvastatin calcium
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA206536
Marketing category
ANDA
Marketing start
2024-06-12
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
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 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
50090-7720-0atorvastatin calcium30 in 1 BOTTLETABLET301
50090-7720-1atorvastatin calcium90 in 1 BOTTLETABLET901
50090-7720-2atorvastatin calcium100 in 1 BOTTLETABLET1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7720-0EA - Each50090-77204b7aaf42-9fbe-4bf1-a48f-9b03048537da12025-12-16
50090-7720-1EA - Each50090-7720c2db4b36-347a-4de1-9bac-c1c60f4160f312025-12-16
50090-7720-2EA - Each50090-772025939332-a2c2-4f76-ad7a-3a819b43588c12025-12-16

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617312atorvastatin calcium 10 MG Oral TabletPSN993c39c2-afe6-4b92-9251-5695f4524a701
617312atorvastatin 10 MG Oral TabletSCD993c39c2-afe6-4b92-9251-5695f4524a701
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY993c39c2-afe6-4b92-9251-5695f4524a701

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7720-05009077200030 TABLET in 1 BOTTLE (50090-7720-0) 30 tablet2025-10-16NoNoCurrent
50090-7720-15009077200190 TABLET in 1 BOTTLE (50090-7720-1) 90 tablet2025-10-16NoNoCurrent
50090-7720-250090772002100 TABLET in 1 BOTTLE (50090-7720-2) 100 tablet2025-10-16NoNoCurrent