FDA.reportPublic FDA data

Atorvastatin Calcium

Product NDC
71335-2404
11-digit product format
713352404
Labeler code
71335
Product ID
71335-2404_af1b3de0-9c50-407d-a154-afd07d4cd731
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
atorvastatin calcium, film coated
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA209912
Marketing category
ANDA
Marketing start
2023-10-20
Substance
ATORVASTATIN CALCIUM TRIHYDRATE
Active strength
20 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 TRIHYDRATE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii48A5M73Z4Q
Rxcui617310

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
71335-2404-1Atorvastatin Calcium30 in 1 BOTTLETABLET304
71335-2404-2Atorvastatin Calcium60 in 1 BOTTLETABLET604
71335-2404-3Atorvastatin Calcium90 in 1 BOTTLETABLET904
71335-2404-4Atorvastatin Calcium9 in 1 BOTTLETABLET94
71335-2404-5Atorvastatin Calcium28 in 1 BOTTLETABLET284
71335-2404-6Atorvastatin Calcium20 in 1 BOTTLETABLET204
71335-2404-7Atorvastatin Calcium180 in 1 BOTTLETABLET1804
71335-2404-8Atorvastatin Calcium100 in 1 BOTTLETABLET1004
71335-2404-9Atorvastatin Calcium7 in 1 BOTTLETABLET74

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2404-3EA - Each71335-24042c62197b-5f79-4594-b521-f3f3d72188ba12025-08-11
71335-2404-8EA - Each71335-2404113455ea-d89e-4cc3-b3c9-54e7f5f8006912025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2404ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM, FILM COATED) TABLET [BRYANT RANCH PREPACK]4Current NDC, 9 package rows20250519_32b40825-6b0b-4025-86f5-b4e453efea92.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617310atorvastatin calcium 20 MG Oral TabletPSN32b40825-6b0b-4025-86f5-b4e453efea924
617310atorvastatin 20 MG Oral TabletSCD32b40825-6b0b-4025-86f5-b4e453efea924
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY32b40825-6b0b-4025-86f5-b4e453efea924

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2404-17133524040130 TABLET in 1 BOTTLE (71335-2404-1) 30 tablet2024-06-13NoNoHistorical
71335-2404-27133524040260 TABLET in 1 BOTTLE (71335-2404-2) 60 tablet2024-06-13NoNoHistorical
71335-2404-37133524040390 TABLET in 1 BOTTLE (71335-2404-3) 90 tablet2024-06-13NoNoHistorical
71335-2404-4713352404049 TABLET in 1 BOTTLE (71335-2404-4) 9 tablet2024-06-13NoNoHistorical
71335-2404-57133524040528 TABLET in 1 BOTTLE (71335-2404-5) 28 tablet2024-06-13NoNoHistorical
71335-2404-67133524040620 TABLET in 1 BOTTLE (71335-2404-6) 20 tablet2024-06-13NoNoHistorical
71335-2404-771335240407180 TABLET in 1 BOTTLE (71335-2404-7) 180 tablet2024-06-13NoNoHistorical
71335-2404-871335240408100 TABLET in 1 BOTTLE (71335-2404-8) 100 tablet2024-06-13NoNoHistorical
71335-2404-9713352404097 TABLET in 1 BOTTLE (71335-2404-9) 7 tablet2024-06-13NoNoHistorical