FDA.reportPublic FDA data

Atorvastatin Calcium

Product NDC
67877-513
11-digit product format
678770513
Labeler code
67877
Product ID
67877-513_777b866a-796a-4d15-8cb6-dd0c9a1856e2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA209288
Marketing category
ANDA
Marketing start
2018-12-23
Substance
ATORVASTATIN CALCIUM TRIHYDRATE
Active strength
40 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 TRIHYDRATE40 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
67877-513-05Atorvastatin Calcium500 in 1 BOTTLETABLET, FILM COATED50024
67877-513-10Atorvastatin Calcium1000 in 1 BOTTLETABLET, FILM COATED100024
67877-513-23Atorvastatin Calcium2000 in 1 BOTTLETABLET, FILM COATED200024
67877-513-33Atorvastatin Calcium10 in 1 BLISTER PACKTABLET, FILM COATED1024
67877-513-38Atorvastatin Calcium10 in 1 CARTONTABLET, FILM COATED1024
67877-513-90Atorvastatin Calcium90 in 1 BOTTLETABLET, FILM COATED9024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-513-05EA - Each67877-5132ea7556a-9a4e-4360-9228-9e317c5f508512019-09-05
67877-513-10EA - Each67877-513de2a6e17-7f4f-4ab5-96a7-edaa6d922b8212019-02-13
67877-513-90EA - Each67877-513596ead1d-fcf7-4ce4-be09-e32fd629122d12019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-513ATORVASTATIN CALCIUM TABLET, FILM COATED [ASCEND LABORATORIES, LLC]24Current NDC, Legacy NDC, 6 package rows20250507_67e60880-091a-4df7-8696-6e6c42a490e2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617312atorvastatin calcium 10 MG Oral TabletPSN67e60880-091a-4df7-8696-6e6c42a490e224
617310atorvastatin calcium 20 MG Oral TabletPSN67e60880-091a-4df7-8696-6e6c42a490e224
617311atorvastatin calcium 40 MG Oral TabletPSN67e60880-091a-4df7-8696-6e6c42a490e224
259255atorvastatin calcium 80 MG Oral TabletPSN67e60880-091a-4df7-8696-6e6c42a490e224
617312atorvastatin 10 MG Oral TabletSCD67e60880-091a-4df7-8696-6e6c42a490e224
617310atorvastatin 20 MG Oral TabletSCD67e60880-091a-4df7-8696-6e6c42a490e224
617311atorvastatin 40 MG Oral TabletSCD67e60880-091a-4df7-8696-6e6c42a490e224
259255atorvastatin 80 MG Oral TabletSCD67e60880-091a-4df7-8696-6e6c42a490e224
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY67e60880-091a-4df7-8696-6e6c42a490e224
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY67e60880-091a-4df7-8696-6e6c42a490e224
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY67e60880-091a-4df7-8696-6e6c42a490e224
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY67e60880-091a-4df7-8696-6e6c42a490e224
617311atorvastatin calcium 40 MG Oral TabletPSN1cc2dd41-a465-45b6-a80a-67c41af29cf87
617311atorvastatin calcium 40 MG Oral TabletPSN2ad89657-cc95-44a0-af6a-ee756526aa107
617311atorvastatin calcium 40 MG Oral TabletPSNc0e2a5d0-1aa3-e131-e053-2a95a90a98707
617311atorvastatin 40 MG Oral TabletSCD1cc2dd41-a465-45b6-a80a-67c41af29cf87
617311atorvastatin 40 MG Oral TabletSCDc0e2a5d0-1aa3-e131-e053-2a95a90a98707
617311atorvastatin 40 MG Oral TabletSCD2ad89657-cc95-44a0-af6a-ee756526aa107
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY1cc2dd41-a465-45b6-a80a-67c41af29cf87
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSYc0e2a5d0-1aa3-e131-e053-2a95a90a98707
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY2ad89657-cc95-44a0-af6a-ee756526aa107
617311atorvastatin calcium 40 MG Oral TabletPSNf3084cae-db82-4e6f-e053-2995a90aa36a4
617311atorvastatin 40 MG Oral TabletSCDf3084cae-db82-4e6f-e053-2995a90aa36a4
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSYf3084cae-db82-4e6f-e053-2995a90aa36a4
617311atorvastatin calcium 40 MG Oral TabletPSN95729689-8055-45ae-e053-2995a90a919f3
617311atorvastatin calcium 40 MG Oral TabletPSN862f9f27-c645-2d2e-e053-2991aa0a96b93
617311atorvastatin 40 MG Oral TabletSCD95729689-8055-45ae-e053-2995a90a919f3
617311atorvastatin 40 MG Oral TabletSCD862f9f27-c645-2d2e-e053-2991aa0a96b93
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY862f9f27-c645-2d2e-e053-2991aa0a96b93
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY95729689-8055-45ae-e053-2995a90a919f3
617312atorvastatin calcium 10 MG Oral TabletPSN60d51f39-8086-4434-affe-88ab8ca0c7e52
617310atorvastatin calcium 20 MG Oral TabletPSN60d51f39-8086-4434-affe-88ab8ca0c7e52
617311atorvastatin calcium 40 MG Oral TabletPSN60d51f39-8086-4434-affe-88ab8ca0c7e52
617311atorvastatin calcium 40 MG Oral TabletPSN2f8a3672-f108-439a-aeb5-0be5c4a1fdcf2
259255atorvastatin calcium 80 MG Oral TabletPSN60d51f39-8086-4434-affe-88ab8ca0c7e52
617312atorvastatin 10 MG Oral TabletSCD60d51f39-8086-4434-affe-88ab8ca0c7e52
617310atorvastatin 20 MG Oral TabletSCD60d51f39-8086-4434-affe-88ab8ca0c7e52
617311atorvastatin 40 MG Oral TabletSCD60d51f39-8086-4434-affe-88ab8ca0c7e52
617311atorvastatin 40 MG Oral TabletSCD2f8a3672-f108-439a-aeb5-0be5c4a1fdcf2
259255atorvastatin 80 MG Oral TabletSCD60d51f39-8086-4434-affe-88ab8ca0c7e52
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY60d51f39-8086-4434-affe-88ab8ca0c7e52
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY60d51f39-8086-4434-affe-88ab8ca0c7e52
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY60d51f39-8086-4434-affe-88ab8ca0c7e52
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY2f8a3672-f108-439a-aeb5-0be5c4a1fdcf2
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY60d51f39-8086-4434-affe-88ab8ca0c7e52
617311atorvastatin calcium 40 MG Oral TabletPSNba7a8604-93bb-4b82-b160-328ed17f89f91
617311atorvastatin calcium 40 MG Oral TabletPSNab6e6775-3bcb-326e-e053-2a95a90a239b1
617311atorvastatin 40 MG Oral TabletSCDba7a8604-93bb-4b82-b160-328ed17f89f91
617311atorvastatin 40 MG Oral TabletSCDab6e6775-3bcb-326e-e053-2a95a90a239b1
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSYba7a8604-93bb-4b82-b160-328ed17f89f91
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSYab6e6775-3bcb-326e-e053-2a95a90a239b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-513-0567877051305500 TABLET, FILM COATED in 1 BOTTLE (67877-513-05) 2018-12-230000-00-00NoNoCurrent
67877-513-10678770513101000 TABLET, FILM COATED in 1 BOTTLE (67877-513-10) 2018-12-230000-00-00NoNoCurrent
67877-513-23678770513232000 TABLET, FILM COATED in 1 BOTTLE (67877-513-23) 2018-12-230000-00-00NoNoCurrent
67877-513-336787705133310 in 1 BLISTER PACKHistorical
67877-513-386787705133810 BLISTER PACK in 1 CARTON (67877-513-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK (67877-513-33) 10 blister pack2018-12-230000-00-00NoNoCurrent
67877-513-906787705139090 TABLET, FILM COATED in 1 BOTTLE (67877-513-90) 2018-12-230000-00-00NoNoCurrent