Home NDC 55154-4384 Atorvastatin Calcium
Product NDC 55154-4384
11-digit product format 551544384
Labeler code 55154
Product ID 55154-4384_8f2cfaa9-2b7f-4bcf-993a-cd106151d861
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name atorvastatin calcium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Cardinal Health 107, LLC
Application ANDA091226
Marketing category ANDA
Marketing start 2014-01-23
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A091226-001 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2012-05-29 A091226-002 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2012-05-29 A091226-003 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2012-05-29 A091226-004 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-05-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 5 · 164 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A091226-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2012-05-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091226-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2012-05-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091226-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2012-05-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091226-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-05-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091226-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2012-05-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091226-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2012-05-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091226-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2012-05-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091226-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-05-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091226-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2012-05-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091226-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2012-05-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091226-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2012-05-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091226-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-05-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091226-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2012-05-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091226-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2012-05-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091226-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2012-05-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091226-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-05-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091226-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2012-05-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091226-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2012-05-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091226-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2012-05-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091226-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-05-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091226-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2012-05-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091226-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2012-05-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091226-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2012-05-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091226-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-05-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091226-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2012-05-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091226-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2012-05-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091226-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2012-05-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091226-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-05-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091226-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2012-05-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091226-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2012-05-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091226-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2012-05-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091226-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-05-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091226-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2012-05-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091226-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2012-05-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091226-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2012-05-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091226-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-05-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091226-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2012-05-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091226-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2012-05-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091226-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2012-05-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091226-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-05-29 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 164 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Atorvastatin Calcium
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ATORVASTATIN CALCIUM TRIHYDRATE 80 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 48A5M73Z4Q Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 259255 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55154-4384-6 Atorvastatin Calcium 6 in 1 BAG TABLET, FILM COATED 6 13 55154-4384-6 Atorvastatin Calcium 1 in 1 BLISTER PACK TABLET, FILM COATED 1 13
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ATORVASTATIN CALCIUM TRIHYDRATE ACTIVE INGREDIENT 48A5M73Z4Q ATORVASTATIN CALCIUM TABLET, FILM COATED [CARDINAL HEALTH] 2 ATORVASTATIN ACTIVE MOIETY A0JWA85V8F ATORVASTATIN CALCIUM TABLET, FILM COATED [CARDINAL HEALTH] 2 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK ATORVASTATIN CALCIUM TABLET, FILM COATED [CARDINAL HEALTH] 2 ARGININE INACTIVE INGREDIENT 94ZLA3W45F ATORVASTATIN CALCIUM TABLET, FILM COATED [CARDINAL HEALTH] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ATORVASTATIN CALCIUM TABLET, FILM COATED [CARDINAL HEALTH] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 ATORVASTATIN CALCIUM TABLET, FILM COATED [CARDINAL HEALTH] 2 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P ATORVASTATIN CALCIUM TABLET, FILM COATED [CARDINAL HEALTH] 2 LECITHIN, SOYBEAN INACTIVE INGREDIENT 1DI56QDM62 ATORVASTATIN CALCIUM TABLET, FILM COATED [CARDINAL HEALTH] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ATORVASTATIN CALCIUM TABLET, FILM COATED [CARDINAL HEALTH] 2 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 ATORVASTATIN CALCIUM TABLET, FILM COATED [CARDINAL HEALTH] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ATORVASTATIN CALCIUM TABLET, FILM COATED [CARDINAL HEALTH] 2 SODIUM CARBONATE INACTIVE INGREDIENT 45P3261C7T ATORVASTATIN CALCIUM TABLET, FILM COATED [CARDINAL HEALTH] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U ATORVASTATIN CALCIUM TABLET, FILM COATED [CARDINAL HEALTH] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ATORVASTATIN CALCIUM TABLET, FILM COATED [CARDINAL HEALTH] 2 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE ATORVASTATIN CALCIUM TABLET, FILM COATED [CARDINAL HEALTH] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55154-4384 ATORVASTATIN CALCIUM TABLET, FILM COATED [CARDINAL HEALTH 107, LLC] 10 Current NDC, Legacy NDC, 2 package rows 20250524_aee307d6-b3fa-424f-8656-1f30ff413e95.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Atorvastatin Calcium ATORVASTATIN CALCIUM Cardinal Health 107, LLC fbd1c5da-67fb-4412-acb5-4d4c74a43654 2026-07-24 Warnings, Adverse reactions Exact identifier application applno (ANDA): 091226 application number: ANDA091226 Atorvastatin Calcium ATORVASTATIN CALCIUM Cardinal Health 107, LLC aee307d6-b3fa-424f-8656-1f30ff413e95 2026-05-01 Warnings, Adverse reactions Exact identifier application applno (ANDA): 091226 application number: ANDA091226 ndc (product): 55154-4384 Atorvastatin Calcium ATORVASTATIN CALCIUM Safecor Health, LLC 6d552a6f-d7a2-4dba-8e71-2b97b4ee2faf 2026-02-24 Warnings, Adverse reactions Exact identifier application applno (ANDA): 091226 application number: ANDA091226 Atorvastatin Calcium ATORVASTATIN CALCIUM Mylan Institutional Inc. 7c1083b9-7a20-475d-ba12-4f5d0b53e601 2025-07-18 Warnings, Adverse reactions Exact identifier application applno (ANDA): 091226 application number: ANDA091226 Atorvastatin Calcium ATORVASTATIN CALCIUM Mylan Pharmaceuticals Inc. d0a0feb6-84f0-4693-a11f-eb4f7ae0a87d 2024-04-12 Warnings, Adverse reactions Exact identifier application applno (ANDA): 091226 application number: ANDA091226
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55154-4384-6 55154438406 6 BLISTER PACK in 1 BAG (55154-4384-6) / 1 TABLET, FILM COATED in 1 BLISTER PACK 6 blister pack 2014-01-23 0000-00-00 No No Current