FDA.reportPublic FDA data

Atorvastatin Calcium

Product NDC
68180-636
11-digit product format
681800636
Labeler code
68180
Product ID
68180-636_ab716c10-785b-4d43-a5f0-59f95b0b78c8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin Calcium
Dosage form
TABLET
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA204991
Marketing category
ANDA
Marketing start
2020-09-24
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
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
68180-636-02Atorvastatin Calcium500 in 1 BOTTLETABLET50017
68180-636-06Atorvastatin Calcium30 in 1 BOTTLETABLET3017
68180-636-09Atorvastatin Calcium90 in 1 BOTTLETABLET9017

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-636ATORVASTATIN CALCIUM TABLET [LUPIN PHARMACEUTICALS, INC.]17Current NDC, Legacy NDC, 3 package rows20231216_a5767370-15a2-45e5-b980-7af9523aea7b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617310atorvastatin calcium 20 MG Oral TabletPSN5868d3c2-ae17-4a7e-9580-7c3cf9bf009e103
617310atorvastatin 20 MG Oral TabletSCD5868d3c2-ae17-4a7e-9580-7c3cf9bf009e103
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY5868d3c2-ae17-4a7e-9580-7c3cf9bf009e103
617312atorvastatin calcium 10 MG Oral TabletPSNa5767370-15a2-45e5-b980-7af9523aea7b17
617310atorvastatin calcium 20 MG Oral TabletPSNa5767370-15a2-45e5-b980-7af9523aea7b17
617311atorvastatin calcium 40 MG Oral TabletPSNa5767370-15a2-45e5-b980-7af9523aea7b17
259255atorvastatin calcium 80 MG Oral TabletPSNa5767370-15a2-45e5-b980-7af9523aea7b17
617312atorvastatin 10 MG Oral TabletSCDa5767370-15a2-45e5-b980-7af9523aea7b17
617310atorvastatin 20 MG Oral TabletSCDa5767370-15a2-45e5-b980-7af9523aea7b17
617311atorvastatin 40 MG Oral TabletSCDa5767370-15a2-45e5-b980-7af9523aea7b17
259255atorvastatin 80 MG Oral TabletSCDa5767370-15a2-45e5-b980-7af9523aea7b17
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSYa5767370-15a2-45e5-b980-7af9523aea7b17
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSYa5767370-15a2-45e5-b980-7af9523aea7b17
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSYa5767370-15a2-45e5-b980-7af9523aea7b17
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSYa5767370-15a2-45e5-b980-7af9523aea7b17
617310atorvastatin calcium 20 MG Oral TabletPSNd3f27113-785c-419e-955a-d6782fade4383
617310atorvastatin 20 MG Oral TabletSCDd3f27113-785c-419e-955a-d6782fade4383
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSYd3f27113-785c-419e-955a-d6782fade4383
617310atorvastatin calcium 20 MG Oral TabletPSNc4fd47d5-4a9e-efb0-e053-2995a90a58cc1
617310atorvastatin 20 MG Oral TabletSCDc4fd47d5-4a9e-efb0-e053-2995a90a58cc1
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSYc4fd47d5-4a9e-efb0-e053-2995a90a58cc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-636-0268180063602500 TABLET in 1 BOTTLE (68180-636-02) 500 tablet2020-09-240000-00-00NoNoCurrent
68180-636-066818006360630 TABLET in 1 BOTTLE (68180-636-06) 30 tablet2020-09-240000-00-00NoNoCurrent
68180-636-096818006360990 TABLET in 1 BOTTLE (68180-636-09) 90 tablet2020-09-240000-00-00NoNoCurrent