Home NDC 70518-2727-2 Lovastatin
Product NDC 70518-2727
Requested package NDC 70518-2727-2
11-digit product format 705182727
Labeler code 70518
Product ID 70518-2727_d4263f4f-b47c-b1df-e053-2a95a90a2896
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name lovastatin
Dosage form TABLET
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA078296
Marketing category ANDA
Marketing start 2020-05-05
Marketing end 0000-00-00
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 2022-12-31
Current FDA listing Historical FDA.report record
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# FDA-Initiated Inactive NDC Indexing# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70518-2727 LOVASTATIN TABLET [REMEDYREPACK INC.] 11 Legacy NDC 20250331_fb1b0b49-749d-41b2-b04f-198de4a5e02f.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 70518-2727-2 70518272702 90 TABLET in 1 BOTTLE, PLASTIC (70518-2727-2) 90 tablet 2021-12-23 0000-00-00 No No Current