FDA.reportPublic FDA data

Atorvastatin calcium

Product NDC
33342-317
11-digit product format
333420317
Labeler code
33342
Product ID
33342-317_7bd0f0ec-f7a3-4403-9a1a-11f18213631f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin calcium
Dosage form
TABLET
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA208480
Marketing category
ANDA
Marketing start
2024-06-03
Substance
ATORVASTATIN CALCIUM TRIHYDRATE
Active strength
40 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 TRIHYDRATE40 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
33342-317-10Atorvastatin calcium90 in 1 BOTTLETABLET901
33342-317-12Atorvastatin calcium10 in 1 BLISTER PACKTABLET101
33342-317-12Atorvastatin calcium10 in 1 CARTONTABLET101
33342-317-15Atorvastatin calcium500 in 1 BOTTLETABLET5001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617312atorvastatin calcium 10 MG Oral TabletPSN7bd0f0ec-f7a3-4403-9a1a-11f18213631f1
617310atorvastatin calcium 20 MG Oral TabletPSN7bd0f0ec-f7a3-4403-9a1a-11f18213631f1
617311atorvastatin calcium 40 MG Oral TabletPSN7bd0f0ec-f7a3-4403-9a1a-11f18213631f1
259255atorvastatin calcium 80 MG Oral TabletPSN7bd0f0ec-f7a3-4403-9a1a-11f18213631f1
617312atorvastatin 10 MG Oral TabletSCD7bd0f0ec-f7a3-4403-9a1a-11f18213631f1
617310atorvastatin 20 MG Oral TabletSCD7bd0f0ec-f7a3-4403-9a1a-11f18213631f1
617311atorvastatin 40 MG Oral TabletSCD7bd0f0ec-f7a3-4403-9a1a-11f18213631f1
259255atorvastatin 80 MG Oral TabletSCD7bd0f0ec-f7a3-4403-9a1a-11f18213631f1
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY7bd0f0ec-f7a3-4403-9a1a-11f18213631f1
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY7bd0f0ec-f7a3-4403-9a1a-11f18213631f1
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY7bd0f0ec-f7a3-4403-9a1a-11f18213631f1
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY7bd0f0ec-f7a3-4403-9a1a-11f18213631f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
33342-317-103334203171090 TABLET in 1 BOTTLE (33342-317-10) 90 tablet2024-06-03NoNoHistorical
33342-317-123334203171210 BLISTER PACK in 1 CARTON (33342-317-12) / 10 TABLET in 1 BLISTER PACK10 blister pack2024-06-03NoNoHistorical
33342-317-1533342031715500 TABLET in 1 BOTTLE (33342-317-15) 500 tablet2024-06-03NoNoHistorical