Home NDC 0071-0158-92 Lipitor
Product NDC 0071-0158
Requested package NDC 0071-0158-92
11-digit product format 000710158
Labeler code 0071
Product ID 0071-0158_6202c6a5-77e4-437a-859f-2ebe201f1c82
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name atorvastatin calcium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Parke-Davis Div of Pfizer Inc
Application NDA020702
Marketing category NDA
Marketing start 2000-04-07
Marketing end 0000-00-00
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 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 · 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 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# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ATORVASTATIN CALCIUM TRIHYDRATE ACTIVE INGREDIENT 48A5M73Z4Q LIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC] 15 ATORVASTATIN ACTIVE MOIETY A0JWA85V8F LIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC] 15 CALCIUM CARBONATE INACTIVE INGREDIENT H0G9379FGK LIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC] 15 CANDELILLA WAX INACTIVE INGREDIENT WL0328HX19 LIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC] 15 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC] 15 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 LIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC] 15 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P LIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC] 15 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO LIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC] 15 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X LIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC] 15 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC] 15 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A LIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC] 15 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H LIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC] 15 TALC INACTIVE INGREDIENT 7SEV7J4R1U LIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC] 15 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC] 15 ATORVASTATIN CALCIUM ACTIVE INGREDIENT 48A5M73Z4Q LIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC] 5 ATORVASTATIN ACTIVE MOIETY A0JWA85V8F LIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC] 5 CALCIUM CARBONATE INACTIVE INGREDIENT H0G9379FGK LIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC] 5 CANDELILLA WAX INACTIVE INGREDIENT WL0328HX19 LIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC] 5 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC] 5 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 LIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC] 5 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P LIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC] 5 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO LIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC] 5 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X LIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC] 5 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A LIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC] 5 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H LIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC] 5 TALC INACTIVE INGREDIENT 7SEV7J4R1U LIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC] 5 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC] 5 atorvastatin calcium ACTIVE INGREDIENT 48A5M73Z4Q LIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PHARMAKON, LLC] 1 atorvastatin ACTIVE MOIETY A0JWA85V8F LIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PHARMAKON, LLC] 1 calcium carbonate INACTIVE INGREDIENT H0G9379FGK LIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PHARMAKON, LLC] 1 candelilla wax INACTIVE INGREDIENT WL0328HX19 LIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PHARMAKON, LLC] 1 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U LIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PHARMAKON, LLC] 1 croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 LIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PHARMAKON, LLC] 1 hydroxypropyl cellulose INACTIVE INGREDIENT RFW2ET671P LIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PHARMAKON, LLC] 1 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO LIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PHARMAKON, LLC] 1 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X LIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PHARMAKON, LLC] 1 magnesium stearate INACTIVE INGREDIENT 70097M6I30 LIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PHARMAKON, LLC] 1 polyethylene glycol INACTIVE INGREDIENT 3WJQ0SDW1A LIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PHARMAKON, LLC] 1 polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H LIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PHARMAKON, LLC] 1 talc INACTIVE INGREDIENT 7SEV7J4R1U LIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PHARMAKON, LLC] 1 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP LIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PHARMAKON, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0071-0158 LIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [PARKE-DAVIS DIV OF PFIZER INC] 42 Legacy NDC 20240502_c6e131fe-e7df-4876-83f7-9156fc4e8228.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 Units Marketing start Marketing end Sample Exclude flag Status 0071-0158-92 00071015892 64 BLISTER PACK in 1 CARTON (0071-0158-92) > 1 TABLET, FILM COATED in 1 BLISTER PACK 64 blister pack 2000-04-07 2023-07-31 No No Current