FDA.reportPublic FDA data

Atorvastatin calcium

Product NDC
60290-042
11-digit product format
602900042
Labeler code
60290
Product ID
60290-042_4999f880-cf37-837f-e063-6394a90a72d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin calcium
Dosage form
TABLET
Route
ORAL
Labeler
Umedica Laboratories USA Inc.
Application
ANDA213853
Marketing category
ANDA
Marketing start
2026-02-15
Substance
ATORVASTATIN
Active strength
80 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Atorvastatin calcium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATORVASTATIN80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiA0JWA85V8F
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
60290-042-01Atorvastatin calcium90 in 1 BOTTLETABLET901
60290-042-02Atorvastatin calcium500 in 1 BOTTLETABLET5001
60290-042-03Atorvastatin calcium2000 in 1 BOTTLETABLET20001
60290-042-04Atorvastatin calcium1000 in 1 BOTTLETABLET10001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60290-042-01EA - Each60290-0421b6a93ce-8b7e-4723-b607-8daf95bed50112026-05-22
60290-042-04EA - Each60290-04272f23e25-ac9d-4f97-892d-b4fa9815940712026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617312atorvastatin calcium 10 MG Oral TabletPSN5a7594ca-30be-4350-827f-ef745a2a7e181
617310atorvastatin calcium 20 MG Oral TabletPSN5a7594ca-30be-4350-827f-ef745a2a7e181
617311atorvastatin calcium 40 MG Oral TabletPSN5a7594ca-30be-4350-827f-ef745a2a7e181
259255atorvastatin calcium 80 MG Oral TabletPSN5a7594ca-30be-4350-827f-ef745a2a7e181
617312atorvastatin 10 MG Oral TabletSCD5a7594ca-30be-4350-827f-ef745a2a7e181
617310atorvastatin 20 MG Oral TabletSCD5a7594ca-30be-4350-827f-ef745a2a7e181
617311atorvastatin 40 MG Oral TabletSCD5a7594ca-30be-4350-827f-ef745a2a7e181
259255atorvastatin 80 MG Oral TabletSCD5a7594ca-30be-4350-827f-ef745a2a7e181
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY5a7594ca-30be-4350-827f-ef745a2a7e181
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY5a7594ca-30be-4350-827f-ef745a2a7e181
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY5a7594ca-30be-4350-827f-ef745a2a7e181
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY5a7594ca-30be-4350-827f-ef745a2a7e181

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60290-042-016029000420190 TABLET in 1 BOTTLE (60290-042-01) 90 tablet2026-02-15NoNoCurrent
60290-042-0260290004202500 TABLET in 1 BOTTLE (60290-042-02) 500 tablet2026-02-15NoNoCurrent
60290-042-03602900042032000 TABLET in 1 BOTTLE (60290-042-03) 2000 tablet2026-02-15NoNoCurrent
60290-042-04602900042041000 TABLET in 1 BOTTLE (60290-042-04) 1000 tablet2026-02-15NoNoCurrent