Home NDC 43353-120-45 ATORVASTATIN CALCIUM
Product NDC 43353-120
Requested package NDC 43353-120-45
11-digit product format 433530120
Labeler code 43353
Product ID 43353-120_67dce28b-a634-42eb-b565-93d513ab9b10
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ATORVASTATIN CALCIUM
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application NDA020702
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2013-01-28
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 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N020702-001 LIPITOR ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB RLD 1996-12-17 N020702-002 LIPITOR ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB RLD 1996-12-17 N020702-003 LIPITOR ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB RLD 1996-12-17 N020702-004 LIPITOR ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB RLD, RS 2000-04-07
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 · 168 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 2026-08-18 06:07:40 2026-07 N020702-001 LIPITOR EQ 10MG BASE TABLET / ORAL AB RLD 1996-12-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020702-002 LIPITOR EQ 20MG BASE TABLET / ORAL AB RLD 1996-12-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020702-003 LIPITOR EQ 40MG BASE TABLET / ORAL AB RLD 1996-12-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020702-004 LIPITOR EQ 80MG BASE TABLET / ORAL AB RLD, RS 2000-04-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020702-001 LIPITOR EQ 10MG BASE TABLET / ORAL AB RLD 1996-12-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020702-002 LIPITOR EQ 20MG BASE TABLET / ORAL AB RLD 1996-12-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020702-003 LIPITOR EQ 40MG BASE TABLET / ORAL AB RLD 1996-12-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020702-004 LIPITOR EQ 80MG BASE TABLET / ORAL AB RLD, RS 2000-04-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020702-001 LIPITOR EQ 10MG BASE TABLET / ORAL AB RLD 1996-12-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020702-002 LIPITOR EQ 20MG BASE TABLET / ORAL AB RLD 1996-12-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020702-003 LIPITOR EQ 40MG BASE TABLET / ORAL AB RLD 1996-12-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020702-004 LIPITOR EQ 80MG BASE TABLET / ORAL AB RLD, RS 2000-04-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020702-001 LIPITOR EQ 10MG BASE TABLET / ORAL AB RLD 1996-12-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020702-002 LIPITOR EQ 20MG BASE TABLET / ORAL AB RLD 1996-12-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020702-003 LIPITOR EQ 40MG BASE TABLET / ORAL AB RLD 1996-12-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020702-004 LIPITOR EQ 80MG BASE TABLET / ORAL AB RLD, RS 2000-04-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020702-001 LIPITOR EQ 10MG BASE TABLET / ORAL AB RLD 1996-12-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020702-002 LIPITOR EQ 20MG BASE TABLET / ORAL AB RLD 1996-12-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020702-003 LIPITOR EQ 40MG BASE TABLET / ORAL AB RLD 1996-12-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020702-004 LIPITOR EQ 80MG BASE TABLET / ORAL AB RLD, RS 2000-04-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020702-001 LIPITOR EQ 10MG BASE TABLET / ORAL AB RLD 1996-12-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020702-002 LIPITOR EQ 20MG BASE TABLET / ORAL AB RLD 1996-12-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020702-003 LIPITOR EQ 40MG BASE TABLET / ORAL AB RLD 1996-12-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020702-004 LIPITOR EQ 80MG BASE TABLET / ORAL AB RLD, RS 2000-04-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020702-001 LIPITOR EQ 10MG BASE TABLET / ORAL AB RLD 1996-12-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020702-002 LIPITOR EQ 20MG BASE TABLET / ORAL AB RLD 1996-12-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020702-003 LIPITOR EQ 40MG BASE TABLET / ORAL AB RLD 1996-12-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020702-004 LIPITOR EQ 80MG BASE TABLET / ORAL AB RLD, RS 2000-04-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020702-001 LIPITOR EQ 10MG BASE TABLET / ORAL AB RLD 1996-12-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020702-002 LIPITOR EQ 20MG BASE TABLET / ORAL AB RLD 1996-12-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020702-003 LIPITOR EQ 40MG BASE TABLET / ORAL AB RLD 1996-12-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020702-004 LIPITOR EQ 80MG BASE TABLET / ORAL AB RLD, RS 2000-04-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020702-001 LIPITOR EQ 10MG BASE TABLET / ORAL AB RLD 1996-12-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020702-002 LIPITOR EQ 20MG BASE TABLET / ORAL AB RLD 1996-12-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020702-003 LIPITOR EQ 40MG BASE TABLET / ORAL AB RLD 1996-12-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020702-004 LIPITOR EQ 80MG BASE TABLET / ORAL AB RLD, RS 2000-04-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020702-001 LIPITOR EQ 10MG BASE TABLET / ORAL AB RLD 1996-12-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020702-002 LIPITOR EQ 20MG BASE TABLET / ORAL AB RLD 1996-12-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020702-003 LIPITOR EQ 40MG BASE TABLET / ORAL AB RLD 1996-12-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020702-004 LIPITOR EQ 80MG BASE TABLET / ORAL AB RLD, RS 2000-04-07 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 168 observed states.
Observed Orange Book exclusivity history# 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 43353-120-45 ATORVASTATIN CALCIUM 45 in 1 BOTTLE TABLET, FILM COATED 45 4 43353-120-60 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 43353-120 ATORVASTATIN CALCIUM TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 4 Legacy NDC, 2 package rows 20191219_b0f54cad-3ff2-4c3b-9ef1-b888c4d6c25c.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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lipitor ATORVASTATIN CALCIUM Viatris Specialty LLC a60cc18b-0631-4cf0-b021-9f52224ece65 2024-04-15 Warnings, Adverse reactions Exact identifier application applno (NDA): 020702 application number: NDA020702
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 43353-120-45 43353012045 45 TABLET, FILM COATED in 1 BOTTLE (43353-120-45) 2015-11-04 0000-00-00 No No Current