FDA.reportPublic FDA data

Atorvastatin Calcium

Product NDC
67877-511
11-digit product format
678770511
Labeler code
67877
Product ID
67877-511_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
10 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 TRIHYDRATE10 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
67877-511-05Atorvastatin Calcium500 in 1 BOTTLETABLET, FILM COATED50024
67877-511-10Atorvastatin Calcium1000 in 1 BOTTLETABLET, FILM COATED100024
67877-511-33Atorvastatin Calcium10 in 1 BLISTER PACKTABLET, FILM COATED1024
67877-511-38Atorvastatin Calcium10 in 1 CARTONTABLET, FILM COATED1024
67877-511-55Atorvastatin Calcium5000 in 1 BOTTLETABLET, FILM COATED500024
67877-511-90Atorvastatin Calcium90 in 1 BOTTLETABLET, FILM COATED9024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-511-05EA - Each67877-511dc9a3bc4-51b3-4248-aa3c-fe3f9bd5a97412019-09-05
67877-511-10EA - Each67877-51139cc4e63-b693-49b7-906a-5a72ff13494212019-02-13
67877-511-90EA - Each67877-51181b8e478-87a8-40e9-bcd1-5b3a180b07d612019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-511ATORVASTATIN 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 TabletPSN2035c49b-f319-4dce-bf1c-c2f64e786fb7104
617312atorvastatin 10 MG Oral TabletSCD2035c49b-f319-4dce-bf1c-c2f64e786fb7104
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY2035c49b-f319-4dce-bf1c-c2f64e786fb7104
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
617312atorvastatin calcium 10 MG Oral TabletPSNe6d068ed-f9d2-4fd1-9755-b76bea89725e7
617312atorvastatin 10 MG Oral TabletSCDe6d068ed-f9d2-4fd1-9755-b76bea89725e7
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSYe6d068ed-f9d2-4fd1-9755-b76bea89725e7
617312atorvastatin calcium 10 MG Oral TabletPSN57f9b462-f08e-483c-9b64-b7e4c8d469275
617312atorvastatin 10 MG Oral TabletSCD57f9b462-f08e-483c-9b64-b7e4c8d469275
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY57f9b462-f08e-483c-9b64-b7e4c8d469275
617312atorvastatin calcium 10 MG Oral TabletPSN8ee8b455-625c-ead6-e053-2a95a90aed293
617312atorvastatin 10 MG Oral TabletSCD8ee8b455-625c-ead6-e053-2a95a90aed293
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY8ee8b455-625c-ead6-e053-2a95a90aed293
617312atorvastatin calcium 10 MG Oral TabletPSN60d51f39-8086-4434-affe-88ab8ca0c7e52
617312atorvastatin calcium 10 MG Oral TabletPSN635bde6e-baf9-4894-bcd6-09b9d86e8f1c2
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
617312atorvastatin 10 MG Oral TabletSCD635bde6e-baf9-4894-bcd6-09b9d86e8f1c2
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 TabletSY635bde6e-baf9-4894-bcd6-09b9d86e8f1c2
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
617312atorvastatin calcium 10 MG Oral TabletPSN26a3da77-1024-68c3-e063-6394a90a27751
617312atorvastatin calcium 10 MG Oral TabletPSN8f23b974-8ba7-4316-8d9e-25aff81124221
617312atorvastatin calcium 10 MG Oral TabletPSNa82562dc-8b3e-3b35-e053-2995a90a3c251
617312atorvastatin 10 MG Oral TabletSCD8f23b974-8ba7-4316-8d9e-25aff81124221
617312atorvastatin 10 MG Oral TabletSCDa82562dc-8b3e-3b35-e053-2995a90a3c251
617312atorvastatin 10 MG Oral TabletSCD26a3da77-1024-68c3-e063-6394a90a27751
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY8f23b974-8ba7-4316-8d9e-25aff81124221
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSYa82562dc-8b3e-3b35-e053-2995a90a3c251
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY26a3da77-1024-68c3-e063-6394a90a27751

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-511-0567877051105500 TABLET, FILM COATED in 1 BOTTLE (67877-511-05) 2018-12-230000-00-00NoNoCurrent
67877-511-10678770511101000 TABLET, FILM COATED in 1 BOTTLE (67877-511-10) 2018-12-230000-00-00NoNoCurrent
67877-511-336787705113310 in 1 BLISTER PACKHistorical
67877-511-386787705113810 BLISTER PACK in 1 CARTON (67877-511-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK (67877-511-33) 10 blister pack2018-12-230000-00-00NoNoCurrent
67877-511-55678770511555000 TABLET, FILM COATED in 1 BOTTLE (67877-511-55) 2018-12-230000-00-00NoNoCurrent
67877-511-906787705119090 TABLET, FILM COATED in 1 BOTTLE (67877-511-90) 2018-12-230000-00-00NoNoCurrent