Home NDC 53002-1439-9 Atorvastatin Calcium
Product NDC 53002-1439
Requested package NDC 53002-1439-9
11-digit product format 530021439
Labeler code 53002
Product ID 53002-1439_f7993792-af33-4431-bb8a-6ec679e5e805
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Atorvastatin Calcium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler RPK Pharmaceuticals, Inc.
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 2021-12-31
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, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2020-12-18 03:04 UTC · source 2020-12-17 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 · 164 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 2026-02-19 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…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091624-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2013-04-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091624-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2013-04-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091624-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2013-04-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091624-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2013-04-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091624-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2013-04-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091624-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2013-04-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091624-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2013-04-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091624-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2013-04-05 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 164 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 53002-1439-0 2025-01-30 These highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN CALCIUM tablets, for oral use Initial U.S. Approval: 1996 53002-1439-3 2025-01-30 These highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN CALCIUM tablets, for oral use Initial U.S. Approval: 1996 53002-1439-9 2025-01-30 These highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN CALCIUM tablets, for oral use Initial U.S. Approval: 1996 53002-1439-0 2023-06-07 These highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN CALCIUM tablets, for oral use Initial U.S. Approval: 1996 53002-1439-3 2023-06-07 These highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN CALCIUM tablets, for oral use Initial U.S. Approval: 1996 53002-1439-9 2023-06-07 These highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN CALCIUM tablets, for oral use Initial U.S. Approval: 1996 53002-1439-0 2023-01-30 These highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN CALCIUM tablets, for oral use Initial U.S. Approval: 1996 53002-1439-3 2023-01-30 These highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN CALCIUM tablets, for oral use Initial U.S. Approval: 1996 53002-1439-9 2023-01-30 These highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN CALCIUM tablets, for oral use Initial U.S. Approval: 1996 53002-1439-0 2020-12-16 These highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN CALCIUM tablets, for oral use Initial U.S. Approval: 1996 53002-1439-3 2020-12-16 These highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN CALCIUM tablets, for oral use Initial U.S. Approval: 1996 53002-1439-9 2020-12-16 These highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN CALCIUM tablets, for oral use Initial U.S. Approval: 1996 53002-1439-0 2020-01-31 These highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN CALCIUM tablets, for oral use Initial U.S. Approval: 1996 53002-1439-3 2020-01-31 These highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN CALCIUM tablets, for oral use Initial U.S. Approval: 1996 53002-1439-9 2020-01-31 These highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN CALCIUM tablets, for oral use Initial U.S. Approval: 1996
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53002-1439-0 Atorvastatin Calcium 100 in 1 BOTTLE TABLET, FILM COATED 100 8 53002-1439-3 Atorvastatin Calcium 30 in 1 BOTTLE TABLET, FILM COATED 30 8 53002-1439-9 Atorvastatin Calcium 90 in 1 BOTTLE TABLET, FILM COATED 90 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53002-1439 ATORVASTATIN CALCIUM TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.] 8 Legacy NDC, 3 package rows 20230609_e1d39d2f-7c65-4b68-acfa-0d345714ce6e.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 53002-1439-9 53002143909 90 TABLET, FILM COATED in 1 BOTTLE (53002-1439-9) 2017-09-01 0000-00-00 No No Current