Home NDC 55700-659 Atorvastatin Calcium
Product NDC 55700-659
11-digit product format 557000659
Labeler code 55700
Product ID 55700-659_a3b99c14-f41e-4d37-a96a-eb5f8572cada
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Atorvastatin Calcium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Lake Erie Medical DBA Quality Care Products LLC
Application ANDA091624
Marketing category ANDA
Marketing start 2018-07-20
Marketing end 0000-00-00
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 2020-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 55700-659-30 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 55700-659-30 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 55700-659-30 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 55700-659-30 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 55700-659-30 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 55700-659-30 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 55700-659-30 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 55700-659-30 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 55700-659-30 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 55700-659-30 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 55700-659-30 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 55700-659-30 557ba5c1ecfa…9c80585c8c6e…
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 A091624-001 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2013-04-05 A091624-002 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2013-04-05 A091624-003 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2013-04-05 A091624-004 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2013-04-05
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 A091624-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2013-04-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091624-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2013-04-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091624-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2013-04-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091624-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2013-04-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091624-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2013-04-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091624-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2013-04-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091624-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2013-04-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091624-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2013-04-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091624-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2013-04-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091624-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2013-04-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091624-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2013-04-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091624-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2013-04-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091624-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2013-04-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091624-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2013-04-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091624-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2013-04-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091624-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2013-04-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091624-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2013-04-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091624-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2013-04-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091624-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2013-04-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091624-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2013-04-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091624-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2013-04-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091624-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2013-04-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091624-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2013-04-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091624-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2013-04-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091624-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2013-04-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091624-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2013-04-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091624-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2013-04-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091624-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2013-04-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091624-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2013-04-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091624-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2013-04-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091624-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2013-04-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091624-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2013-04-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091624-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2013-04-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091624-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2013-04-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091624-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2013-04-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091624-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2013-04-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091624-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2013-04-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091624-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2013-04-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091624-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2013-04-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091624-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2013-04-05 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 164 observed states.