FDA.reportPublic FDA data

atorvastatin calcium

Product NDC
70771-1876
11-digit product format
707711876
Labeler code
70771
Product ID
70771-1876_81d15801-dbb6-486a-9257-d80f6c3bc867
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
atorvastatin calcium
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA206536
Marketing category
ANDA
Marketing start
2024-06-12
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
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
70771-1876-0atorvastatin calcium1000 in 1 BOTTLETABLET10004
70771-1876-5atorvastatin calcium500 in 1 BOTTLETABLET5004
70771-1876-9atorvastatin calcium90 in 1 BOTTLETABLET904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1876ATORVASTATIN CALCIUM TABLET [ZYDUS LIFESCIENCES LIMITED]3Current NDC, 3 package rows20241127_06028adf-fcb5-452c-ba67-ee53bc65c519.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617312atorvastatin calcium 10 MG Oral TabletPSN06028adf-fcb5-452c-ba67-ee53bc65c5194
617310atorvastatin calcium 20 MG Oral TabletPSN06028adf-fcb5-452c-ba67-ee53bc65c5194
617311atorvastatin calcium 40 MG Oral TabletPSN06028adf-fcb5-452c-ba67-ee53bc65c5194
259255atorvastatin calcium 80 MG Oral TabletPSN06028adf-fcb5-452c-ba67-ee53bc65c5194
617312atorvastatin 10 MG Oral TabletSCD06028adf-fcb5-452c-ba67-ee53bc65c5194
617310atorvastatin 20 MG Oral TabletSCD06028adf-fcb5-452c-ba67-ee53bc65c5194
617311atorvastatin 40 MG Oral TabletSCD06028adf-fcb5-452c-ba67-ee53bc65c5194
259255atorvastatin 80 MG Oral TabletSCD06028adf-fcb5-452c-ba67-ee53bc65c5194
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY06028adf-fcb5-452c-ba67-ee53bc65c5194
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY06028adf-fcb5-452c-ba67-ee53bc65c5194
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY06028adf-fcb5-452c-ba67-ee53bc65c5194
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY06028adf-fcb5-452c-ba67-ee53bc65c5194

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70771-1876-0707711876001000 TABLET in 1 BOTTLE (70771-1876-0) 1000 tablet2024-06-12NoNoHistorical
70771-1876-570771187605500 TABLET in 1 BOTTLE (70771-1876-5) 500 tablet2024-06-12NoNoHistorical
70771-1876-97077118760990 TABLET in 1 BOTTLE (70771-1876-9) 90 tablet2024-06-12NoNoHistorical