FDA.reportPublic FDA data

Atorvastatin Calcium

Product NDC
70377-078
11-digit product format
703770078
Labeler code
70377
Product ID
70377-078_72b8b3f5-4658-80af-655c-87ce7966a5e6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
atorvastatin calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Biocon Pharma Inc.
Application
ANDA216436
Marketing category
ANDA
Marketing start
2023-03-01
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
70377-078-11Atorvastatin Calcium90 in 1 BOTTLETABLET, FILM COATED9010
70377-078-12Atorvastatin Calcium500 in 1 BOTTLETABLET, FILM COATED50010
70377-078-13Atorvastatin Calcium1000 in 1 BOTTLETABLET, FILM COATED100010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70377-078-11EA - Each70377-0783c7c8b16-95b2-4139-8557-285e95e6631312024-02-14
70377-078-13EA - Each70377-078d39f7909-9243-4e2a-8320-a298c6a4375a12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70377-078ATORVASTATIN CALCIUM TABLET, FILM COATED [BIOCON PHARMA INC.]10Current NDC, 3 package rows20250306_5b839619-1805-c227-91bf-182f5b966ba4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617312atorvastatin calcium 10 MG Oral TabletPSN5b839619-1805-c227-91bf-182f5b966ba410
617310atorvastatin calcium 20 MG Oral TabletPSN5b839619-1805-c227-91bf-182f5b966ba410
617311atorvastatin calcium 40 MG Oral TabletPSN5b839619-1805-c227-91bf-182f5b966ba410
259255atorvastatin calcium 80 MG Oral TabletPSN5b839619-1805-c227-91bf-182f5b966ba410
617312atorvastatin 10 MG Oral TabletSCD5b839619-1805-c227-91bf-182f5b966ba410
617310atorvastatin 20 MG Oral TabletSCD5b839619-1805-c227-91bf-182f5b966ba410
617311atorvastatin 40 MG Oral TabletSCD5b839619-1805-c227-91bf-182f5b966ba410
259255atorvastatin 80 MG Oral TabletSCD5b839619-1805-c227-91bf-182f5b966ba410
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY5b839619-1805-c227-91bf-182f5b966ba410
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY5b839619-1805-c227-91bf-182f5b966ba410
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY5b839619-1805-c227-91bf-182f5b966ba410
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY5b839619-1805-c227-91bf-182f5b966ba410
617310atorvastatin calcium 20 MG Oral TabletPSN6e6a3b6b-5536-434e-bd1d-7dc7256704ce3
617310atorvastatin 20 MG Oral TabletSCD6e6a3b6b-5536-434e-bd1d-7dc7256704ce3
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY6e6a3b6b-5536-434e-bd1d-7dc7256704ce3
617310atorvastatin calcium 20 MG Oral TabletPSNf3af6315-08b5-4ff9-80ae-2984f05986111
617310atorvastatin calcium 20 MG Oral TabletPSN261b6b9c-b85e-2fc1-e063-6294a90a258a1
617310atorvastatin calcium 20 MG Oral TabletPSN12751ca4-cde3-92dd-e063-6294a90a4e9d1
617310atorvastatin 20 MG Oral TabletSCD261b6b9c-b85e-2fc1-e063-6294a90a258a1
617310atorvastatin 20 MG Oral TabletSCDf3af6315-08b5-4ff9-80ae-2984f05986111
617310atorvastatin 20 MG Oral TabletSCD12751ca4-cde3-92dd-e063-6294a90a4e9d1
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY261b6b9c-b85e-2fc1-e063-6294a90a258a1
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY12751ca4-cde3-92dd-e063-6294a90a4e9d1
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSYf3af6315-08b5-4ff9-80ae-2984f05986111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70377-078-117037700781190 TABLET, FILM COATED in 1 BOTTLE (70377-078-11) 2023-03-01NoNoHistorical
70377-078-1270377007812500 TABLET, FILM COATED in 1 BOTTLE (70377-078-12) 2023-03-01NoNoHistorical
70377-078-13703770078131000 TABLET, FILM COATED in 1 BOTTLE (70377-078-13) 2023-03-01NoNoHistorical