Home NDC 71335-0169 Atorvastatin Calcium
Product NDC 71335-0169
11-digit product format 713350169
Labeler code 71335
Product ID 71335-0169_59ac6203-1603-49ee-b45f-f3008fd9ff12
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Atorvastatin Calcium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA091624
Marketing category ANDA
Marketing start 2013-04-05
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 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 3 · 177 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 product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 71335-0169-1 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 71335-0169-3 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 71335-0169-5 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 71335-0169-1 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 71335-0169-3 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 71335-0169-4 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 71335-0169-2 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 71335-0169-2 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 71335-0169-5 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 71335-0169-6 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 71335-0169-4 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 product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 71335-0169-1 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 71335-0169-3 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 71335-0169-5 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 71335-0169-1 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 71335-0169-3 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 71335-0169-4 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 71335-0169-2 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 71335-0169-2 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 71335-0169-5 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 71335-0169-6 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 71335-0169-4 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 product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 71335-0169-1 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 71335-0169-3 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 71335-0169-5 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 71335-0169-1 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 71335-0169-3 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 71335-0169-4 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 71335-0169-2 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 71335-0169-2 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 71335-0169-5 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 71335-0169-6 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 71335-0169-4 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 product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 71335-0169-1 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 71335-0169-3 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 71335-0169-5 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 71335-0169-1 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 71335-0169-3 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 71335-0169-4 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 71335-0169-2 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 71335-0169-2 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 71335-0169-5 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 71335-0169-6 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 71335-0169-4 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 product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 71335-0169-1 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 71335-0169-3 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 71335-0169-5 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 71335-0169-1 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 71335-0169-3 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 71335-0169-4 D Discontinued by firm cfe11265f3b6…090c488252e2…
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 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 · 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 A091624-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2013-04-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A091624-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2013-04-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A091624-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2013-04-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A091624-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2013-04-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 A091624-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2013-04-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091624-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2013-04-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091624-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2013-04-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091624-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2013-04-05 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 172 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 71335-0169-1 Atorvastatin Calcium 30 in 1 BOTTLE TABLET, FILM COATED 30 100 71335-0169-2 Atorvastatin Calcium 90 in 1 BOTTLE TABLET, FILM COATED 90 100 71335-0169-3 Atorvastatin Calcium 60 in 1 BOTTLE TABLET, FILM COATED 60 100 71335-0169-4 Atorvastatin Calcium 120 in 1 BOTTLE TABLET, FILM COATED 120 100 71335-0169-5 Atorvastatin Calcium 100 in 1 BOTTLE TABLET, FILM COATED 100 100 71335-0169-6 Atorvastatin Calcium 180 in 1 BOTTLE TABLET, FILM COATED 180 100
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-0169 ATORVASTATIN CALCIUM TABLET, FILM COATED [BRYANT RANCH PREPACK] 100 Legacy NDC, 6 package rows 20220224_48ee52ca-7602-4d55-a111-94813cf761ba.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 71335-0169-1 71335016901 30 TABLET, FILM COATED in 1 BOTTLE (71335-0169-1) 2022-02-23 0000-00-00 No No Current 71335-0169-2 71335016902 90 TABLET, FILM COATED in 1 BOTTLE (71335-0169-2) 2022-02-23 0000-00-00 No No Current 71335-0169-3 71335016903 60 TABLET, FILM COATED in 1 BOTTLE (71335-0169-3) 2022-02-23 0000-00-00 No No Current 71335-0169-4 71335016904 120 TABLET, FILM COATED in 1 BOTTLE (71335-0169-4) 2022-02-23 0000-00-00 No No Current 71335-0169-5 71335016905 100 TABLET, FILM COATED in 1 BOTTLE (71335-0169-5) 2022-02-23 0000-00-00 No No Current 71335-0169-6 71335016906 180 TABLET, FILM COATED in 1 BOTTLE (71335-0169-6) 2022-02-23 0000-00-00 No No Current