FDA.reportPublic FDA data

Atorvastatin Calcium

Product NDC
67877-512
11-digit product format
678770512
Labeler code
67877
Product ID
67877-512_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
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
67877-512-05Atorvastatin Calcium500 in 1 BOTTLETABLET, FILM COATED50024
67877-512-10Atorvastatin Calcium1000 in 1 BOTTLETABLET, FILM COATED100024
67877-512-33Atorvastatin Calcium10 in 1 BLISTER PACKTABLET, FILM COATED1024
67877-512-38Atorvastatin Calcium10 in 1 CARTONTABLET, FILM COATED1024
67877-512-44Atorvastatin Calcium4000 in 1 BOTTLETABLET, FILM COATED400024
67877-512-90Atorvastatin Calcium90 in 1 BOTTLETABLET, FILM COATED9024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-512-05EA - Each67877-51296ba597b-4a60-443c-8133-de31d198fd6812019-09-05
67877-512-10EA - Each67877-512af9f789d-5d90-4e05-80e2-a66a314512fc12019-02-13
67877-512-90EA - Each67877-512b1b06abe-bd22-44f9-8bab-f9bfc4e77e3a12019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-512ATORVASTATIN 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
617310atorvastatin calcium 20 MG Oral TabletPSN09cb8375-075c-47e8-a4eb-8ac667ed849e9
617310atorvastatin 20 MG Oral TabletSCD09cb8375-075c-47e8-a4eb-8ac667ed849e9
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY09cb8375-075c-47e8-a4eb-8ac667ed849e9
617310atorvastatin calcium 20 MG Oral TabletPSN103cc381-3266-409d-bdc2-1de620bae3558
617310atorvastatin 20 MG Oral TabletSCD103cc381-3266-409d-bdc2-1de620bae3558
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY103cc381-3266-409d-bdc2-1de620bae3558
617310atorvastatin calcium 20 MG Oral TabletPSN0ec97c59-9d17-45f8-93f9-2c1f0361cb757
617310atorvastatin 20 MG Oral TabletSCD0ec97c59-9d17-45f8-93f9-2c1f0361cb757
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY0ec97c59-9d17-45f8-93f9-2c1f0361cb757
617310atorvastatin calcium 20 MG Oral TabletPSNbd216f5d-f319-7d8d-e053-2a95a90aa9ce6
617310atorvastatin 20 MG Oral TabletSCDbd216f5d-f319-7d8d-e053-2a95a90aa9ce6
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSYbd216f5d-f319-7d8d-e053-2a95a90aa9ce6
617310atorvastatin calcium 20 MG Oral TabletPSNc9f55cb6-a41b-dd27-e053-2a95a90aaeb74
617310atorvastatin 20 MG Oral TabletSCDc9f55cb6-a41b-dd27-e053-2a95a90aaeb74
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSYc9f55cb6-a41b-dd27-e053-2a95a90aaeb74
617310atorvastatin calcium 20 MG Oral TabletPSN862f58d1-476c-2c90-e053-2991aa0ab8213
617310atorvastatin 20 MG Oral TabletSCD862f58d1-476c-2c90-e053-2991aa0ab8213
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY862f58d1-476c-2c90-e053-2991aa0ab8213
617312atorvastatin calcium 10 MG Oral TabletPSN60d51f39-8086-4434-affe-88ab8ca0c7e52
617310atorvastatin calcium 20 MG Oral TabletPSNab6e98f5-60b4-0cf0-e053-2a95a90a41da2
617310atorvastatin calcium 20 MG Oral TabletPSNd841ca90-a8dc-4bf2-ade3-51e03e8280272
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 TabletSCDab6e98f5-60b4-0cf0-e053-2a95a90a41da2
617310atorvastatin 20 MG Oral TabletSCD60d51f39-8086-4434-affe-88ab8ca0c7e52
617310atorvastatin 20 MG Oral TabletSCDd841ca90-a8dc-4bf2-ade3-51e03e8280272
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 TabletSYab6e98f5-60b4-0cf0-e053-2a95a90a41da2
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY60d51f39-8086-4434-affe-88ab8ca0c7e52
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSYd841ca90-a8dc-4bf2-ade3-51e03e8280272
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY60d51f39-8086-4434-affe-88ab8ca0c7e52
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY60d51f39-8086-4434-affe-88ab8ca0c7e52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-512-0567877051205500 TABLET, FILM COATED in 1 BOTTLE (67877-512-05) 2018-12-230000-00-00NoNoCurrent
67877-512-10678770512101000 TABLET, FILM COATED in 1 BOTTLE (67877-512-10) 2018-12-230000-00-00NoNoCurrent
67877-512-336787705123310 in 1 BLISTER PACKHistorical
67877-512-386787705123810 BLISTER PACK in 1 CARTON (67877-512-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK (67877-512-33) 10 blister pack2018-12-230000-00-00NoNoCurrent
67877-512-44678770512444000 TABLET, FILM COATED in 1 BOTTLE (67877-512-44) 2018-12-230000-00-00NoNoCurrent
67877-512-906787705129090 TABLET, FILM COATED in 1 BOTTLE (67877-512-90) 2018-12-230000-00-00NoNoCurrent