FDA.reportPublic FDA data

Atorvastatin Calcium

Product NDC
16571-138
11-digit product format
165710138
Labeler code
16571
Product ID
16571-138_b94c6347-161c-44f2-8937-34c5098bf755
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
atorvastatin calcium, film coated
Dosage form
TABLET
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA209912
Marketing category
ANDA
Marketing start
2023-10-20
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
16571-138-09Atorvastatin Calcium90 in 1 BOTTLETABLET903
16571-138-10Atorvastatin Calcium1000 in 1 BOTTLETABLET10003
16571-138-50Atorvastatin Calcium500 in 1 BOTTLETABLET5003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-138ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM, FILM COATED) TABLET [RISING PHARMA HOLDINGS, INC.]2Current NDC, 3 package rows20250327_73cefb0b-1747-4fe0-b252-377f4ed94c6f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617312atorvastatin calcium 10 MG Oral TabletPSN73cefb0b-1747-4fe0-b252-377f4ed94c6f3
617310atorvastatin calcium 20 MG Oral TabletPSN73cefb0b-1747-4fe0-b252-377f4ed94c6f3
617311atorvastatin calcium 40 MG Oral TabletPSN73cefb0b-1747-4fe0-b252-377f4ed94c6f3
259255atorvastatin calcium 80 MG Oral TabletPSN73cefb0b-1747-4fe0-b252-377f4ed94c6f3
617312atorvastatin 10 MG Oral TabletSCD73cefb0b-1747-4fe0-b252-377f4ed94c6f3
617310atorvastatin 20 MG Oral TabletSCD73cefb0b-1747-4fe0-b252-377f4ed94c6f3
617311atorvastatin 40 MG Oral TabletSCD73cefb0b-1747-4fe0-b252-377f4ed94c6f3
259255atorvastatin 80 MG Oral TabletSCD73cefb0b-1747-4fe0-b252-377f4ed94c6f3
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY73cefb0b-1747-4fe0-b252-377f4ed94c6f3
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY73cefb0b-1747-4fe0-b252-377f4ed94c6f3
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY73cefb0b-1747-4fe0-b252-377f4ed94c6f3
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY73cefb0b-1747-4fe0-b252-377f4ed94c6f3
617311atorvastatin calcium 40 MG Oral TabletPSN9c58c4cd-fe1c-4db7-832c-874766e4da212
617311atorvastatin 40 MG Oral TabletSCD9c58c4cd-fe1c-4db7-832c-874766e4da212
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY9c58c4cd-fe1c-4db7-832c-874766e4da212
617311atorvastatin calcium 40 MG Oral TabletPSN7fc58ce3-f069-409b-b36f-bb23ce21fb6f1
617311atorvastatin calcium 40 MG Oral TabletPSN3bde7950-3d25-a86e-e063-6394a90ae6231
617311atorvastatin 40 MG Oral TabletSCD7fc58ce3-f069-409b-b36f-bb23ce21fb6f1
617311atorvastatin 40 MG Oral TabletSCD3bde7950-3d25-a86e-e063-6394a90ae6231
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY3bde7950-3d25-a86e-e063-6394a90ae6231
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY7fc58ce3-f069-409b-b36f-bb23ce21fb6f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
16571-138-091657101380990 TABLET in 1 BOTTLE (16571-138-09) 90 tablet2023-10-20NoNoCurrent
16571-138-10165710138101000 TABLET in 1 BOTTLE (16571-138-10) 1000 tablet2023-10-20NoNoCurrent
16571-138-5016571013850500 TABLET in 1 BOTTLE (16571-138-50) 500 tablet2023-10-20NoNoCurrent