Home NDC 53489-609 lovastatin
Product NDC 53489-609
11-digit product format 534890609
Labeler code 53489
Product ID 53489-609_36f83432-6257-4cda-9902-510ec4b0975c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name lovastatin
Dosage form TABLET
Route ORAL
Labeler Mutual Pharmaceutical Company, Inc.
Application ANDA077520
Marketing category ANDA
Marketing start 2006-04-14
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 E
Listing certified through 2017-12-31
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 · 154 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A077520-001 LOVASTATIN LOVASTATIN 10MG TABLET / ORAL 2006-04-14 A077520-002 LOVASTATIN LOVASTATIN 20MG TABLET / ORAL 2006-04-14 A077520-003 LOVASTATIN LOVASTATIN 40MG TABLET / ORAL 2006-04-14
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 · 129 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 A077520-001 LOVASTATIN 10MG TABLET / ORAL 2006-04-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077520-002 LOVASTATIN 20MG TABLET / ORAL 2006-04-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077520-003 LOVASTATIN 40MG TABLET / ORAL 2006-04-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077520-001 LOVASTATIN 10MG TABLET / ORAL 2006-04-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077520-002 LOVASTATIN 20MG TABLET / ORAL 2006-04-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077520-003 LOVASTATIN 40MG TABLET / ORAL 2006-04-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077520-001 LOVASTATIN 10MG TABLET / ORAL 2006-04-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077520-002 LOVASTATIN 20MG TABLET / ORAL 2006-04-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077520-003 LOVASTATIN 40MG TABLET / ORAL 2006-04-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077520-001 LOVASTATIN 10MG TABLET / ORAL 2006-04-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077520-002 LOVASTATIN 20MG TABLET / ORAL 2006-04-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077520-003 LOVASTATIN 40MG TABLET / ORAL 2006-04-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077520-001 LOVASTATIN 10MG TABLET / ORAL 2006-04-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077520-002 LOVASTATIN 20MG TABLET / ORAL 2006-04-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077520-003 LOVASTATIN 40MG TABLET / ORAL 2006-04-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077520-001 LOVASTATIN 10MG TABLET / ORAL 2006-04-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077520-002 LOVASTATIN 20MG TABLET / ORAL 2006-04-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077520-003 LOVASTATIN 40MG TABLET / ORAL 2006-04-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077520-001 LOVASTATIN 10MG TABLET / ORAL 2006-04-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077520-002 LOVASTATIN 20MG TABLET / ORAL 2006-04-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077520-003 LOVASTATIN 40MG TABLET / ORAL 2006-04-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077520-001 LOVASTATIN 10MG TABLET / ORAL 2006-04-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077520-002 LOVASTATIN 20MG TABLET / ORAL 2006-04-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077520-003 LOVASTATIN 40MG TABLET / ORAL 2006-04-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077520-001 LOVASTATIN 10MG TABLET / ORAL 2006-04-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077520-002 LOVASTATIN 20MG TABLET / ORAL 2006-04-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077520-003 LOVASTATIN 40MG TABLET / ORAL 2006-04-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077520-001 LOVASTATIN 10MG TABLET / ORAL 2006-04-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077520-002 LOVASTATIN 20MG TABLET / ORAL 2006-04-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077520-003 LOVASTATIN 40MG TABLET / ORAL 2006-04-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077520-001 LOVASTATIN 10MG TABLET / ORAL 2006-04-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077520-002 LOVASTATIN 20MG TABLET / ORAL 2006-04-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077520-003 LOVASTATIN 40MG TABLET / ORAL 2006-04-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077520-001 LOVASTATIN 10MG TABLET / ORAL 2006-04-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077520-002 LOVASTATIN 20MG TABLET / ORAL 2006-04-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077520-003 LOVASTATIN 40MG TABLET / ORAL 2006-04-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077520-001 LOVASTATIN 10MG TABLET / ORAL 2006-04-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077520-002 LOVASTATIN 20MG TABLET / ORAL 2006-04-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077520-003 LOVASTATIN 40MG TABLET / ORAL 2006-04-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077520-001 LOVASTATIN 10MG TABLET / ORAL 2006-04-14 301d65b070ca…
Observed Orange Book normalized TE history# 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 53489-609-01 lovastatin 100 in 1 BOTTLE, PLASTIC TABLET 100 5 53489-609-03 lovastatin 250 in 1 BOTTLE, PLASTIC TABLET 250 5 53489-609-05 lovastatin 500 in 1 BOTTLE, PLASTIC TABLET 500 5 53489-609-06 lovastatin 60 in 1 BOTTLE, PLASTIC TABLET 60 5 53489-609-07 lovastatin 30 in 1 BOTTLE, PLASTIC TABLET 30 5 53489-609-10 lovastatin 1000 in 1 BOTTLE, PLASTIC TABLET 1000 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded lovastatin ACTIVE INGREDIENT 9LHU78OQFD LOVASTATIN TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] 5 lovastatin ACTIVE MOIETY 9LHU78OQFD LOVASTATIN TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] 5 aluminum oxide INACTIVE INGREDIENT LMI26O6933 LOVASTATIN TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] 5 butylated hydroxyanisole INACTIVE INGREDIENT REK4960K2U LOVASTATIN TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] 5 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U LOVASTATIN TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] 5 FD&C blue no. 2 INACTIVE INGREDIENT L06K8R7DQK LOVASTATIN TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] 5 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X LOVASTATIN TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] 5 magnesium stearate INACTIVE INGREDIENT 70097M6I30 LOVASTATIN TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] 5 starch, corn INACTIVE INGREDIENT O8232NY3SJ LOVASTATIN TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53489-609 LOVASTATIN TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] 5 Legacy NDC, 6 package rows 20130105_caf7c3af-8256-4557-af40-e8143e9af9f1.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 53489-609-01 53489060901 100 in 1 BOTTLE, PLASTIC Historical 53489-609-03 53489060903 250 in 1 BOTTLE, PLASTIC Historical 53489-609-05 53489060905 500 in 1 BOTTLE, PLASTIC Historical 53489-609-06 53489060906 60 in 1 BOTTLE, PLASTIC Historical 53489-609-07 53489060907 30 in 1 BOTTLE, PLASTIC Historical 53489-609-10 53489060910 1000 in 1 BOTTLE, PLASTIC Historical