Atorvastatin Calcium

Product NDC
71209-090
11-digit product format
712090090
Labeler code
71209
Product ID
71209-090_547579c7-a528-413f-b402-00f598775df3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin Calcium
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Cadila Pharmaceuticals Limited
Application
ANDA212103
Marketing category
ANDA
Marketing start
2018-07-06
Substance
ATORVASTATIN CALCIUM TRIHYDRATE
Active strength
10 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 TRIHYDRATE10 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
71209-090-04Atorvastatin Calcium90 in 1 BOTTLETABLET, COATED908

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71209-090ATORVASTATIN CALCIUM TABLET, COATED [CADILA PHARMACEUTICALS LIMITED]8Current NDC, 1 package rows20240607_51730b09-24e8-41c8-9fec-813f8a64b433.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617312atorvastatin calcium 10 MG Oral TabletPSN51730b09-24e8-41c8-9fec-813f8a64b4338
617310atorvastatin calcium 20 MG Oral TabletPSN51730b09-24e8-41c8-9fec-813f8a64b4338
617311atorvastatin calcium 40 MG Oral TabletPSN51730b09-24e8-41c8-9fec-813f8a64b4338
259255atorvastatin calcium 80 MG Oral TabletPSN51730b09-24e8-41c8-9fec-813f8a64b4338
617312atorvastatin 10 MG Oral TabletSCD51730b09-24e8-41c8-9fec-813f8a64b4338
617310atorvastatin 20 MG Oral TabletSCD51730b09-24e8-41c8-9fec-813f8a64b4338
617311atorvastatin 40 MG Oral TabletSCD51730b09-24e8-41c8-9fec-813f8a64b4338
259255atorvastatin 80 MG Oral TabletSCD51730b09-24e8-41c8-9fec-813f8a64b4338
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY51730b09-24e8-41c8-9fec-813f8a64b4338
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY51730b09-24e8-41c8-9fec-813f8a64b4338
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY51730b09-24e8-41c8-9fec-813f8a64b4338
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY51730b09-24e8-41c8-9fec-813f8a64b4338

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71209-090-047120900900490 TABLET, COATED in 1 BOTTLE (71209-090-04) 2018-07-06NoNoCurrent