Home NDC 55289-800 Lipitor
Product NDC 55289-800
11-digit product format 552890800
Labeler code 55289
Product ID 55289-800_dabfa0f2-0062-f0ee-e053-2a95a90aec9b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name atorvastatin calcium trihydrate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application NDA020702
Marketing category NDA
Marketing start 1996-12-17
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 2023-12-31
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 55289-800-30 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 55289-800-30 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 55289-800-30 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 55289-800-30 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 55289-800-30 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 55289-800-30 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 55289-800-30 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 55289-800-30 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 55289-800-30 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 55289-800-30 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 55289-800-30 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 55289-800-30 557ba5c1ecfa…9c80585c8c6e…
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 Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded atorvastatin calcium trihydrate ACTIVE INGREDIENT 48A5M73Z4Q LIPITOR (ATORVASTATIN CALCIUM TRIHYDRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 8 atorvastatin ACTIVE MOIETY A0JWA85V8F LIPITOR (ATORVASTATIN CALCIUM TRIHYDRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 8 calcium carbonate INACTIVE INGREDIENT H0G9379FGK LIPITOR (ATORVASTATIN CALCIUM TRIHYDRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 8 candelilla wax INACTIVE INGREDIENT WL0328HX19 LIPITOR (ATORVASTATIN CALCIUM TRIHYDRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 8 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U LIPITOR (ATORVASTATIN CALCIUM TRIHYDRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 8 croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 LIPITOR (ATORVASTATIN CALCIUM TRIHYDRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 8 hydroxypropyl cellulose INACTIVE INGREDIENT RFW2ET671P LIPITOR (ATORVASTATIN CALCIUM TRIHYDRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 8 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO LIPITOR (ATORVASTATIN CALCIUM TRIHYDRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 8 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X LIPITOR (ATORVASTATIN CALCIUM TRIHYDRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 8 magnesium stearate INACTIVE INGREDIENT 70097M6I30 LIPITOR (ATORVASTATIN CALCIUM TRIHYDRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 8 polyethylene glycols INACTIVE INGREDIENT 3WJQ0SDW1A LIPITOR (ATORVASTATIN CALCIUM TRIHYDRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 8 polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H LIPITOR (ATORVASTATIN CALCIUM TRIHYDRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 8 talc INACTIVE INGREDIENT 7SEV7J4R1U LIPITOR (ATORVASTATIN CALCIUM TRIHYDRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 8 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP LIPITOR (ATORVASTATIN CALCIUM TRIHYDRATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 8
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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 55289-800-30 55289080030 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-800-30) 2012-02-29 0000-00-00 No No Current