Home NDC 61919-632 ATORVASTATIN CALCIUM
Product NDC 61919-632
11-digit product format 619190632
Labeler code 61919
Product ID 61919-632_f2151bf2-f790-5213-e053-2a95a90aaf2a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ATORVASTATIN CALCIUM
Dosage form TABLET, FILM COATED
Route ORAL
Labeler DIRECT RX
Application ANDA091624
Marketing category ANDA
Marketing start 2018-10-31
Marketing end 0000-00-00
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 2024-12-31
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 · 27 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 61919-632-90 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 61919-632-30 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 61919-632-90 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 61919-632-30 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 61919-632-90 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 61919-632-30 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 61919-632-90 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 61919-632-30 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 61919-632-90 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 61919-632-30 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 61919-632-90 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 61919-632-30 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 61919-632-90 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 61919-632-30 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 61919-632-90 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 61919-632-30 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 61919-632-90 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 61919-632-30 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
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.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61919-632-30 ATORVASTATIN CALCIUM 30 in 1 BOTTLE TABLET, FILM COATED 30 4 61919-632-90 ATORVASTATIN CALCIUM 90 in 1 BOTTLE TABLET, FILM COATED 90 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61919-632 ATORVASTATIN CALCIUM TABLET, FILM COATED [DIRECT RX] 4 Legacy NDC, 2 package rows 20230510_7986b43a-74b5-a963-e053-2991aa0a669e.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 61919-632-30 61919063230 30 TABLET, FILM COATED in 1 BOTTLE (61919-632-30) 2018-10-31 0000-00-00 No No Current 61919-632-90 61919063290 90 TABLET, FILM COATED in 1 BOTTLE (61919-632-90) 2018-10-31 0000-00-00 No No Current