FDA.reportPublic FDA data

ATORVASTATIN CALCIUM

Product NDC
72603-282
11-digit product format
726030282
Labeler code
72603
Product ID
72603-282_23198422-5895-dbbb-e063-6394a90a9474
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATORVASTATIN CALCIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NorthStar RxLLC
Application
ANDA214344
Marketing category
ANDA
Marketing start
2024-10-01
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
Rxcui259255, 617310, 617311, 617312

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
72603-282-01ATORVASTATIN CALCIUM90 in 1 BOTTLETABLET, FILM COATED901
72603-282-02ATORVASTATIN CALCIUM500 in 1 BOTTLETABLET, FILM COATED5001
72603-282-03ATORVASTATIN CALCIUM1000 in 1 BOTTLETABLET, FILM COATED10001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-282-01EA - Each72603-2828f959e0f-92a0-4b9d-b2df-c377ae5046b812025-01-14
72603-282-02EA - Each72603-2820da54d6b-78f4-4965-ba38-0e3309fe554712025-01-14
72603-282-03EA - Each72603-282b1d995aa-672b-4518-b3a1-20a921300d0312025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-282ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM) TABLET, FILM COATED [NORTHSTAR RXLLC]1Current NDC, 3 package rows20241001_c1ba8fd9-aa40-466c-81bd-a87b364e9a1a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617312atorvastatin calcium 10 MG Oral TabletPSN2f84fd12-3e13-47b0-a628-d22a7c4ac3c01
617312atorvastatin calcium 10 MG Oral TabletPSNac98cfd7-fd4c-4fe1-91f3-50a0e232364f1
617312atorvastatin calcium 10 MG Oral TabletPSNc1ba8fd9-aa40-466c-81bd-a87b364e9a1a1
617310atorvastatin calcium 20 MG Oral TabletPSNc1ba8fd9-aa40-466c-81bd-a87b364e9a1a1
617311atorvastatin calcium 40 MG Oral TabletPSNc1ba8fd9-aa40-466c-81bd-a87b364e9a1a1
259255atorvastatin calcium 80 MG Oral TabletPSNc1ba8fd9-aa40-466c-81bd-a87b364e9a1a1
617312atorvastatin 10 MG Oral TabletSCD2f84fd12-3e13-47b0-a628-d22a7c4ac3c01
617312atorvastatin 10 MG Oral TabletSCDc1ba8fd9-aa40-466c-81bd-a87b364e9a1a1
617312atorvastatin 10 MG Oral TabletSCDac98cfd7-fd4c-4fe1-91f3-50a0e232364f1
617310atorvastatin 20 MG Oral TabletSCDc1ba8fd9-aa40-466c-81bd-a87b364e9a1a1
617311atorvastatin 40 MG Oral TabletSCDc1ba8fd9-aa40-466c-81bd-a87b364e9a1a1
259255atorvastatin 80 MG Oral TabletSCDc1ba8fd9-aa40-466c-81bd-a87b364e9a1a1
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSYc1ba8fd9-aa40-466c-81bd-a87b364e9a1a1
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSYac98cfd7-fd4c-4fe1-91f3-50a0e232364f1
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY2f84fd12-3e13-47b0-a628-d22a7c4ac3c01
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSYc1ba8fd9-aa40-466c-81bd-a87b364e9a1a1
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSYc1ba8fd9-aa40-466c-81bd-a87b364e9a1a1
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSYc1ba8fd9-aa40-466c-81bd-a87b364e9a1a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72603-282-017260302820190 TABLET, FILM COATED in 1 BOTTLE (72603-282-01) 2024-10-01NoNoCurrent
72603-282-0272603028202500 TABLET, FILM COATED in 1 BOTTLE (72603-282-02) 2024-10-01NoNoCurrent
72603-282-03726030282031000 TABLET, FILM COATED in 1 BOTTLE (72603-282-03) 2024-10-01NoNoCurrent