FDA.reportPublic FDA data

ATORVASTATIN CALCIUM

Product NDC
77771-452
11-digit product format
777710452
Labeler code
77771
Product ID
77771-452_323762eb-66a3-4b6b-8e40-3374cc230a93
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATORVASTATIN CALCIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Radha Pharmaceuticals, Inc.
Application
ANDA205519
Marketing category
ANDA
Marketing start
2023-08-10
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ATORVASTATIN CALCIUM
Listing expiration
2027-12-31

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
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
d25cba4b-d79e-4890-8837-1382f7d09489Product name120231002
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
91774e91-b249-45e3-8ff8-4b5db2927a69Product name120230718
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
03fb3cda-d60a-4873-94e9-6fa77cfb1a1cProduct name120220302
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
34152997-af0b-acf4-dcaf-37211afe8ca4Product name920210312
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
46fdf265-6d5a-1bfb-93db-d82a4ea8aa81Product name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77771-452-05ATORVASTATIN CALCIUM500 in 1 BOTTLETABLET, FILM COATED5003
77771-452-90ATORVASTATIN CALCIUM90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
77771-452-05EA - Each77771-452c98cb9b2-2791-4462-92f3-278711e5fd5f12023-09-05
77771-452-90EA - Each77771-452c17d4272-6a1a-4d0f-a1d4-4e2310b0a8a312023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77771-452ATORVASTATIN CALCIUM TABLET, FILM COATED [RADHA PHARMACEUTICALS, INC.]2Current NDC, 2 package rows20241027_10e766cc-c3fd-4584-a0d7-652c516e828c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617312atorvastatin calcium 10 MG Oral TabletPSN10e766cc-c3fd-4584-a0d7-652c516e828c3
617310atorvastatin calcium 20 MG Oral TabletPSN10e766cc-c3fd-4584-a0d7-652c516e828c3
617311atorvastatin calcium 40 MG Oral TabletPSN10e766cc-c3fd-4584-a0d7-652c516e828c3
259255atorvastatin calcium 80 MG Oral TabletPSN10e766cc-c3fd-4584-a0d7-652c516e828c3
617312atorvastatin 10 MG Oral TabletSCD10e766cc-c3fd-4584-a0d7-652c516e828c3
617310atorvastatin 20 MG Oral TabletSCD10e766cc-c3fd-4584-a0d7-652c516e828c3
617311atorvastatin 40 MG Oral TabletSCD10e766cc-c3fd-4584-a0d7-652c516e828c3
259255atorvastatin 80 MG Oral TabletSCD10e766cc-c3fd-4584-a0d7-652c516e828c3
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY10e766cc-c3fd-4584-a0d7-652c516e828c3
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY10e766cc-c3fd-4584-a0d7-652c516e828c3
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY10e766cc-c3fd-4584-a0d7-652c516e828c3
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY10e766cc-c3fd-4584-a0d7-652c516e828c3
617310atorvastatin calcium 20 MG Oral TabletPSN3dbeae00-89ab-48a6-9e57-8048facb22941
617311atorvastatin calcium 40 MG Oral TabletPSN3dbeae00-89ab-48a6-9e57-8048facb22941
259255atorvastatin calcium 80 MG Oral TabletPSN3dbeae00-89ab-48a6-9e57-8048facb22941
617310atorvastatin 20 MG Oral TabletSCD3dbeae00-89ab-48a6-9e57-8048facb22941
617311atorvastatin 40 MG Oral TabletSCD3dbeae00-89ab-48a6-9e57-8048facb22941
259255atorvastatin 80 MG Oral TabletSCD3dbeae00-89ab-48a6-9e57-8048facb22941
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY3dbeae00-89ab-48a6-9e57-8048facb22941
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY3dbeae00-89ab-48a6-9e57-8048facb22941
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY3dbeae00-89ab-48a6-9e57-8048facb22941

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
77771-452-0577771045205500 TABLET, FILM COATED in 1 BOTTLE (77771-452-05) 2023-08-10NoNoCurrent
77771-452-907777104529090 TABLET, FILM COATED in 1 BOTTLE (77771-452-90) 2023-08-10NoNoCurrent