Home NDC 55289-881 Lovastatin
Product NDC 55289-881
11-digit product format 552890881
Labeler code 55289
Product ID 55289-881_dac13313-ecb9-5d37-e053-2995a90a7dac
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name lovastatin
Dosage form TABLET
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA078296
Marketing category ANDA
Marketing start 2007-11-01
Marketing end 0000-00-00
Substance LOVASTATIN
Active strength 20 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 · 3 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product 55289-881 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 55289-881 55289-881-30 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 55289-881 55289-881-90 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A078296-001 LOVASTATIN LOVASTATIN 10MG TABLET / ORAL AB 2008-03-14 A078296-002 LOVASTATIN LOVASTATIN 20MG TABLET / ORAL AB 2007-11-01 A078296-003 LOVASTATIN LOVASTATIN 40MG TABLET / ORAL AB 2007-11-01
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 · 132 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 2026-10-15 13:18:30 2026-09 A078296-001 LOVASTATIN 10MG TABLET / ORAL AB 2008-03-14 c2088c7a36db…2026-10-15 13:18:30 2026-09 A078296-002 LOVASTATIN 20MG TABLET / ORAL AB 2007-11-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 A078296-003 LOVASTATIN 40MG TABLET / ORAL AB 2007-11-01 c2088c7a36db…2026-09-14 22:38:34 2026-08 A078296-001 LOVASTATIN 10MG TABLET / ORAL AB 2008-03-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078296-002 LOVASTATIN 20MG TABLET / ORAL AB 2007-11-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078296-003 LOVASTATIN 40MG TABLET / ORAL AB 2007-11-01 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078296-001 LOVASTATIN 10MG TABLET / ORAL AB 2008-03-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078296-002 LOVASTATIN 20MG TABLET / ORAL AB 2007-11-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078296-003 LOVASTATIN 40MG TABLET / ORAL AB 2007-11-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078296-001 LOVASTATIN 10MG TABLET / ORAL AB 2008-03-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078296-002 LOVASTATIN 20MG TABLET / ORAL AB 2007-11-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078296-003 LOVASTATIN 40MG TABLET / ORAL AB 2007-11-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078296-001 LOVASTATIN 10MG TABLET / ORAL AB 2008-03-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078296-002 LOVASTATIN 20MG TABLET / ORAL AB 2007-11-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078296-003 LOVASTATIN 40MG TABLET / ORAL AB 2007-11-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078296-001 LOVASTATIN 10MG TABLET / ORAL AB 2008-03-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078296-002 LOVASTATIN 20MG TABLET / ORAL AB 2007-11-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078296-003 LOVASTATIN 40MG TABLET / ORAL AB 2007-11-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078296-001 LOVASTATIN 10MG TABLET / ORAL AB 2008-03-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078296-002 LOVASTATIN 20MG TABLET / ORAL AB 2007-11-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078296-003 LOVASTATIN 40MG TABLET / ORAL AB 2007-11-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078296-001 LOVASTATIN 10MG TABLET / ORAL AB 2008-03-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078296-002 LOVASTATIN 20MG TABLET / ORAL AB 2007-11-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078296-003 LOVASTATIN 40MG TABLET / ORAL AB 2007-11-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078296-001 LOVASTATIN 10MG TABLET / ORAL AB 2008-03-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078296-002 LOVASTATIN 20MG TABLET / ORAL AB 2007-11-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078296-003 LOVASTATIN 40MG TABLET / ORAL AB 2007-11-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078296-001 LOVASTATIN 10MG TABLET / ORAL AB 2008-03-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078296-002 LOVASTATIN 20MG TABLET / ORAL AB 2007-11-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078296-003 LOVASTATIN 40MG TABLET / ORAL AB 2007-11-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078296-001 LOVASTATIN 10MG TABLET / ORAL AB 2008-03-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078296-002 LOVASTATIN 20MG TABLET / ORAL AB 2007-11-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078296-003 LOVASTATIN 40MG TABLET / ORAL AB 2007-11-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078296-001 LOVASTATIN 10MG TABLET / ORAL AB 2008-03-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078296-002 LOVASTATIN 20MG TABLET / ORAL AB 2007-11-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078296-003 LOVASTATIN 40MG TABLET / ORAL AB 2007-11-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078296-001 LOVASTATIN 10MG TABLET / ORAL AB 2008-03-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078296-002 LOVASTATIN 20MG TABLET / ORAL AB 2007-11-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078296-003 LOVASTATIN 40MG TABLET / ORAL AB 2007-11-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078296-001 LOVASTATIN 10MG TABLET / ORAL AB 2008-03-14 79d66fd596c7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 132 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LOVASTATIN ACTIVE INGREDIENT 9LHU78OQFD LOVASTATIN (LOVASTATIN) TABLET [PD-RX PHARMACEUTICALS, INC.] 3 LOVASTATIN ACTIVE MOIETY 9LHU78OQFD LOVASTATIN (LOVASTATIN) TABLET [PD-RX PHARMACEUTICALS, INC.] 3 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK LOVASTATIN (LOVASTATIN) TABLET [PD-RX PHARMACEUTICALS, INC.] 3 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U LOVASTATIN (LOVASTATIN) TABLET [PD-RX PHARMACEUTICALS, INC.] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LOVASTATIN (LOVASTATIN) TABLET [PD-RX PHARMACEUTICALS, INC.] 3 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G LOVASTATIN (LOVASTATIN) TABLET [PD-RX PHARMACEUTICALS, INC.] 3 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK LOVASTATIN (LOVASTATIN) TABLET [PD-RX PHARMACEUTICALS, INC.] 3 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X LOVASTATIN (LOVASTATIN) TABLET [PD-RX PHARMACEUTICALS, INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LOVASTATIN (LOVASTATIN) TABLET [PD-RX PHARMACEUTICALS, INC.] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ LOVASTATIN (LOVASTATIN) TABLET [PD-RX PHARMACEUTICALS, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55289-881 LOVASTATIN TABLET [PD-RX PHARMACEUTICALS, INC.] 15 Legacy NDC 20240315_15ca7e87-e640-4788-b3d5-a15a0e3aa034.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 2 of 2 · 21 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55289-881-30 55289088130 30 TABLET in 1 BOTTLE, PLASTIC (55289-881-30) 30 tablet 2015-11-05 0000-00-00 No No Current 55289-881-90 55289088190 90 TABLET in 1 BOTTLE, PLASTIC (55289-881-90) 90 tablet 2015-11-05 0000-00-00 No No Current