Home NDC 43353-995 Lovastatin
Product NDC 43353-995
11-digit product format 433530995
Labeler code 43353
Product ID 43353-995_ca06eda8-31b3-4f42-a57a-630656336e73
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lovastatin
Dosage form TABLET
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA075828
Marketing category ANDA
Marketing start 2014-06-24
Marketing end 0000-00-00
Substance LOVASTATIN
Active strength 40 mg/1
Pharmacologic classes HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2020-12-31
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 · 4 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 43353-995-45 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 43353-995-45 f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075828-001 LOVASTATIN LOVASTATIN 10MG TABLET / ORAL AB 2001-12-17 A075828-002 LOVASTATIN LOVASTATIN 20MG TABLET / ORAL AB 2001-12-17 A075828-003 LOVASTATIN LOVASTATIN 40MG TABLET / ORAL AB 2001-12-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 4 · 126 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 A075828-001 LOVASTATIN 10MG TABLET / ORAL AB 2001-12-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075828-002 LOVASTATIN 20MG TABLET / ORAL AB 2001-12-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075828-003 LOVASTATIN 40MG TABLET / ORAL AB 2001-12-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075828-001 LOVASTATIN 10MG TABLET / ORAL AB 2001-12-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075828-002 LOVASTATIN 20MG TABLET / ORAL AB 2001-12-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075828-003 LOVASTATIN 40MG TABLET / ORAL AB 2001-12-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075828-001 LOVASTATIN 10MG TABLET / ORAL AB 2001-12-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075828-002 LOVASTATIN 20MG TABLET / ORAL AB 2001-12-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075828-003 LOVASTATIN 40MG TABLET / ORAL AB 2001-12-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075828-001 LOVASTATIN 10MG TABLET / ORAL AB 2001-12-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075828-002 LOVASTATIN 20MG TABLET / ORAL AB 2001-12-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075828-003 LOVASTATIN 40MG TABLET / ORAL AB 2001-12-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075828-001 LOVASTATIN 10MG TABLET / ORAL AB 2001-12-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075828-002 LOVASTATIN 20MG TABLET / ORAL AB 2001-12-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075828-003 LOVASTATIN 40MG TABLET / ORAL AB 2001-12-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075828-001 LOVASTATIN 10MG TABLET / ORAL AB 2001-12-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075828-002 LOVASTATIN 20MG TABLET / ORAL AB 2001-12-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075828-003 LOVASTATIN 40MG TABLET / ORAL AB 2001-12-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075828-001 LOVASTATIN 10MG TABLET / ORAL AB 2001-12-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075828-002 LOVASTATIN 20MG TABLET / ORAL AB 2001-12-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075828-003 LOVASTATIN 40MG TABLET / ORAL AB 2001-12-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075828-001 LOVASTATIN 10MG TABLET / ORAL AB 2001-12-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075828-002 LOVASTATIN 20MG TABLET / ORAL AB 2001-12-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075828-003 LOVASTATIN 40MG TABLET / ORAL AB 2001-12-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075828-001 LOVASTATIN 10MG TABLET / ORAL AB 2001-12-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075828-002 LOVASTATIN 20MG TABLET / ORAL AB 2001-12-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075828-003 LOVASTATIN 40MG TABLET / ORAL AB 2001-12-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075828-001 LOVASTATIN 10MG TABLET / ORAL AB 2001-12-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075828-002 LOVASTATIN 20MG TABLET / ORAL AB 2001-12-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075828-003 LOVASTATIN 40MG TABLET / ORAL AB 2001-12-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075828-001 LOVASTATIN 10MG TABLET / ORAL AB 2001-12-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075828-002 LOVASTATIN 20MG TABLET / ORAL AB 2001-12-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075828-003 LOVASTATIN 40MG TABLET / ORAL AB 2001-12-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075828-001 LOVASTATIN 10MG TABLET / ORAL AB 2001-12-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075828-002 LOVASTATIN 20MG TABLET / ORAL AB 2001-12-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075828-003 LOVASTATIN 40MG TABLET / ORAL AB 2001-12-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075828-001 LOVASTATIN 10MG TABLET / ORAL AB 2001-12-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075828-002 LOVASTATIN 20MG TABLET / ORAL AB 2001-12-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075828-003 LOVASTATIN 40MG TABLET / ORAL AB 2001-12-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075828-001 LOVASTATIN 10MG TABLET / ORAL AB 2001-12-17 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43353-995 LOVASTATIN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 Legacy NDC 20160708_0e700413-6ee6-454b-927a-ff5daa97477c.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 43353-995-45 43353099545 45 TABLET in 1 BOTTLE (43353-995-45) 45 tablet 2015-02-13 0000-00-00 No No Current