Home NDC 68645-461-54 ATORVASTATIN CALCIUM
Product NDC 68645-461
Requested package NDC 68645-461-54
11-digit product format 686450461
Labeler code 68645
Product ID 68645-461_5fac3606-5a05-4b01-8fb9-878444bfffeb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ATORVASTATIN CALCIUM
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Legacy Pharmaceutical Packaging, LLC
Application NDA020702
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2011-11-30
Marketing end 2021-04-30
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 0000-00-00
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 · 12 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…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 · 172 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 2026-09-14 22:38:34 2026-08 N020702-001 LIPITOR EQ 10MG BASE TABLET / ORAL AB RLD 1996-12-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020702-002 LIPITOR EQ 20MG BASE TABLET / ORAL AB RLD 1996-12-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020702-003 LIPITOR EQ 40MG BASE TABLET / ORAL AB RLD 1996-12-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020702-004 LIPITOR EQ 80MG BASE TABLET / ORAL AB RLD, RS 2000-04-07 84e616aacf4f…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 172 observed states.
Observed Orange Book exclusivity history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 [LEGACY PHARMACEUTICAL PACKAGING, LLC] 2 ATORVASTATIN ACTIVE MOIETY A0JWA85V8F ATORVASTATIN CALCIUM TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING, LLC] 2 CALCIUM CARBONATE INACTIVE INGREDIENT H0G9379FGK ATORVASTATIN CALCIUM TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING, LLC] 2 CANDELILLA WAX INACTIVE INGREDIENT WL0328HX19 ATORVASTATIN CALCIUM TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING, LLC] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ATORVASTATIN CALCIUM TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING, LLC] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 ATORVASTATIN CALCIUM TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING, LLC] 2 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P ATORVASTATIN CALCIUM TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING, LLC] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ATORVASTATIN CALCIUM TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING, LLC] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X ATORVASTATIN CALCIUM TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING, LLC] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ATORVASTATIN CALCIUM TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING, LLC] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A ATORVASTATIN CALCIUM TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING, LLC] 2 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H ATORVASTATIN CALCIUM TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING, LLC] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U ATORVASTATIN CALCIUM TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING, LLC] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ATORVASTATIN CALCIUM TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING, LLC] 2
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 68645-461-54 68645046154 30 TABLET, FILM COATED in 1 BOTTLE (68645-461-54) 2011-11-30 2021-04-30 No No Current