Home NDC 68001-314 Lovastatin
Product NDC 68001-314
11-digit product format 680010314
Labeler code 68001
Product ID 68001-314_5d3e28ef-e4cb-4fe0-e063-6294a90af647
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name lovastatin
Dosage form TABLET
Route ORAL
Labeler BluePoint Laboratories
Application ANDA078296
Marketing category ANDA
Marketing start 2007-11-01
Substance LOVASTATIN
Active strength 10 mg/1
Pharmacologic classes HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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.
Additional Listing Data#
Finished product Yes
Brand name base Lovastatin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LOVASTATIN 10 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68001-314-00 Lovastatin 100 in 1 BOTTLE TABLET 100 8 68001-314-08 Lovastatin 1000 in 1 BOTTLE TABLET 1000 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68001-314 LOVASTATIN TABLET [BLUEPOINT LABORATORIES] 7 Current NDC, Legacy NDC, 2 package rows 20241116_7b86160d-74a9-4774-b5b3-5641e686991f.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68001-314-00 68001031400 100 TABLET in 1 BOTTLE (68001-314-00) 100 tablet 2017-02-07 0000-00-00 No No Current 68001-314-08 68001031408 1000 TABLET in 1 BOTTLE (68001-314-08) 1000 tablet 2017-02-07 0000-00-00 No No Current