FDA.reportPublic FDA data

Atorvastatin Calcium

Product NDC
67877-514
11-digit product format
678770514
Labeler code
67877
Product ID
67877-514_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
80 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 TRIHYDRATE80 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
67877-514-05Atorvastatin Calcium500 in 1 BOTTLETABLET, FILM COATED50024
67877-514-10Atorvastatin Calcium1000 in 1 BOTTLETABLET, FILM COATED100024
67877-514-33Atorvastatin Calcium10 in 1 BLISTER PACKTABLET, FILM COATED1024
67877-514-38Atorvastatin Calcium10 in 1 CARTONTABLET, FILM COATED1024
67877-514-90Atorvastatin Calcium90 in 1 BOTTLETABLET, FILM COATED9024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-514-05EA - Each67877-514604e229f-dfb2-46f2-a964-cc2f3976520a12019-02-13
67877-514-10EA - Each67877-5141328e3f6-20d5-4362-9f3d-0b5f7d84b54912020-07-13
67877-514-90EA - Each67877-514a08629b6-d111-4056-8049-d1424163bd2712019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-514ATORVASTATIN CALCIUM TABLET, FILM COATED [ASCEND LABORATORIES, LLC]24Current NDC, Legacy NDC, 5 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
259255atorvastatin calcium 80 MG Oral TabletPSNe52b4b11-9618-4787-ae67-44e4a3166dfb6
259255atorvastatin 80 MG Oral TabletSCDe52b4b11-9618-4787-ae67-44e4a3166dfb6
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSYe52b4b11-9618-4787-ae67-44e4a3166dfb6
259255atorvastatin calcium 80 MG Oral TabletPSNda6b77a5-2093-b7f7-e053-2995a90ab10d5
259255atorvastatin 80 MG Oral TabletSCDda6b77a5-2093-b7f7-e053-2995a90ab10d5
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSYda6b77a5-2093-b7f7-e053-2995a90ab10d5
259255atorvastatin calcium 80 MG Oral TabletPSNbdc16768-08fa-91b1-e053-2a95a90a06523
259255atorvastatin 80 MG Oral TabletSCDbdc16768-08fa-91b1-e053-2a95a90a06523
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSYbdc16768-08fa-91b1-e053-2a95a90a06523
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
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
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
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY60d51f39-8086-4434-affe-88ab8ca0c7e52
259255atorvastatin calcium 80 MG Oral TabletPSN1e04df80-9c99-c4c3-e063-6294a90a50651
259255atorvastatin 80 MG Oral TabletSCD1e04df80-9c99-c4c3-e063-6294a90a50651
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY1e04df80-9c99-c4c3-e063-6294a90a50651

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-514-0567877051405500 TABLET, FILM COATED in 1 BOTTLE (67877-514-05) 2018-12-230000-00-00NoNoCurrent
67877-514-10678770514101000 TABLET, FILM COATED in 1 BOTTLE (67877-514-10) 2018-12-230000-00-00NoNoCurrent
67877-514-336787705143310 in 1 BLISTER PACKHistorical
67877-514-386787705143810 BLISTER PACK in 1 CARTON (67877-514-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK (67877-514-33) 10 blister pack2018-12-230000-00-00NoNoCurrent
67877-514-906787705149090 TABLET, FILM COATED in 1 BOTTLE (67877-514-90) 2018-12-230000-00-00NoNoCurrent