FDA.reportPublic FDA data

Atorvastatin Calcium

Product NDC
48433-010
11-digit product format
484330010
Labeler code
48433
Product ID
48433-010_4b986c57-fa32-4b7e-e063-6294a90a50a3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
atorvastatin calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Safecor Health, LLC
Application
ANDA091226
Marketing category
ANDA
Marketing start
2026-02-03
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
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
ATORVASTATIN CALCIUM TRIHYDRATE80 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
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
46fdf265-6d5a-1bfb-93db-d82a4ea8aa81Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48433-010-01Atorvastatin Calcium1 in 1 BLISTER PACKTABLET, FILM COATED12
48433-010-03Atorvastatin Calcium30 in 1 CARTONTABLET, FILM COATED302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
48433-010-03EA - Each48433-010102509b2-2fbe-44af-abe3-e0d1df3ebc9012026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617312atorvastatin calcium 10 MG Oral TabletPSN6d552a6f-d7a2-4dba-8e71-2b97b4ee2faf2
617310atorvastatin calcium 20 MG Oral TabletPSN6d552a6f-d7a2-4dba-8e71-2b97b4ee2faf2
617311atorvastatin calcium 40 MG Oral TabletPSN6d552a6f-d7a2-4dba-8e71-2b97b4ee2faf2
259255atorvastatin calcium 80 MG Oral TabletPSN6d552a6f-d7a2-4dba-8e71-2b97b4ee2faf2
617312atorvastatin 10 MG Oral TabletSCD6d552a6f-d7a2-4dba-8e71-2b97b4ee2faf2
617310atorvastatin 20 MG Oral TabletSCD6d552a6f-d7a2-4dba-8e71-2b97b4ee2faf2
617311atorvastatin 40 MG Oral TabletSCD6d552a6f-d7a2-4dba-8e71-2b97b4ee2faf2
259255atorvastatin 80 MG Oral TabletSCD6d552a6f-d7a2-4dba-8e71-2b97b4ee2faf2
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY6d552a6f-d7a2-4dba-8e71-2b97b4ee2faf2
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY6d552a6f-d7a2-4dba-8e71-2b97b4ee2faf2
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY6d552a6f-d7a2-4dba-8e71-2b97b4ee2faf2
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY6d552a6f-d7a2-4dba-8e71-2b97b4ee2faf2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
48433-010-01484330010011 in 1 BLISTER PACKHistorical
48433-010-034843300100330 BLISTER PACK in 1 CARTON (48433-010-03) / 1 TABLET, FILM COATED in 1 BLISTER PACK (48433-010-01) 30 blister pack2026-02-03NoNoCurrent