Home NDC 42571-080 Simvastatin
Product NDC 42571-080
11-digit product format 425710080
Labeler code 42571
Product ID 42571-080_0369d423-9ef2-0191-e063-6294a90a55e7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Simvastatin
Dosage form TABLET
Route ORAL
Labeler Micro Labs Limited
Application ANDA090383
Marketing category ANDA
Marketing start 2013-06-13
Substance SIMVASTATIN
Active strength 80 mg/1
Pharmacologic classes HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090383-001 SIMVASTATIN SIMVASTATIN 5MG TABLET / ORAL AB 2011-09-16 A090383-002 SIMVASTATIN SIMVASTATIN 10MG TABLET / ORAL AB 2011-09-16 A090383-003 SIMVASTATIN SIMVASTATIN 20MG TABLET / ORAL AB 2011-09-16 A090383-004 SIMVASTATIN SIMVASTATIN 40MG TABLET / ORAL AB 2011-09-16 A090383-005 SIMVASTATIN SIMVASTATIN 80MG TABLET / ORAL AB 2011-09-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 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 6 · 205 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 2026-02-19 14:30 UTC 2026-02 A090383-001 SIMVASTATIN 5MG TABLET / ORAL AB 2011-09-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090383-002 SIMVASTATIN 10MG TABLET / ORAL AB 2011-09-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090383-003 SIMVASTATIN 20MG TABLET / ORAL AB 2011-09-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090383-004 SIMVASTATIN 40MG TABLET / ORAL AB 2011-09-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090383-005 SIMVASTATIN 80MG TABLET / ORAL AB 2011-09-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090383-001 SIMVASTATIN 5MG TABLET / ORAL AB 2011-09-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090383-002 SIMVASTATIN 10MG TABLET / ORAL AB 2011-09-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090383-003 SIMVASTATIN 20MG TABLET / ORAL AB 2011-09-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090383-004 SIMVASTATIN 40MG TABLET / ORAL AB 2011-09-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090383-005 SIMVASTATIN 80MG TABLET / ORAL AB 2011-09-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090383-001 SIMVASTATIN 5MG TABLET / ORAL AB 2011-09-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090383-002 SIMVASTATIN 10MG TABLET / ORAL AB 2011-09-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090383-003 SIMVASTATIN 20MG TABLET / ORAL AB 2011-09-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090383-004 SIMVASTATIN 40MG TABLET / ORAL AB 2011-09-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090383-005 SIMVASTATIN 80MG TABLET / ORAL AB 2011-09-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090383-001 SIMVASTATIN 5MG TABLET / ORAL AB 2011-09-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090383-002 SIMVASTATIN 10MG TABLET / ORAL AB 2011-09-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090383-003 SIMVASTATIN 20MG TABLET / ORAL AB 2011-09-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090383-004 SIMVASTATIN 40MG TABLET / ORAL AB 2011-09-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090383-005 SIMVASTATIN 80MG TABLET / ORAL AB 2011-09-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090383-001 SIMVASTATIN 5MG TABLET / ORAL AB 2011-09-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090383-002 SIMVASTATIN 10MG TABLET / ORAL AB 2011-09-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090383-003 SIMVASTATIN 20MG TABLET / ORAL AB 2011-09-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090383-004 SIMVASTATIN 40MG TABLET / ORAL AB 2011-09-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090383-005 SIMVASTATIN 80MG TABLET / ORAL AB 2011-09-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090383-001 SIMVASTATIN 5MG TABLET / ORAL AB 2011-09-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090383-002 SIMVASTATIN 10MG TABLET / ORAL AB 2011-09-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090383-003 SIMVASTATIN 20MG TABLET / ORAL AB 2011-09-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090383-004 SIMVASTATIN 40MG TABLET / ORAL AB 2011-09-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090383-005 SIMVASTATIN 80MG TABLET / ORAL AB 2011-09-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090383-001 SIMVASTATIN 5MG TABLET / ORAL AB 2011-09-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090383-002 SIMVASTATIN 10MG TABLET / ORAL AB 2011-09-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090383-003 SIMVASTATIN 20MG TABLET / ORAL AB 2011-09-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090383-004 SIMVASTATIN 40MG TABLET / ORAL AB 2011-09-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090383-005 SIMVASTATIN 80MG TABLET / ORAL AB 2011-09-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090383-001 SIMVASTATIN 5MG TABLET / ORAL AB 2011-09-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090383-002 SIMVASTATIN 10MG TABLET / ORAL AB 2011-09-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090383-003 SIMVASTATIN 20MG TABLET / ORAL AB 2011-09-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090383-004 SIMVASTATIN 40MG TABLET / ORAL AB 2011-09-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090383-005 SIMVASTATIN 80MG TABLET / ORAL AB 2011-09-16 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 6 · 205 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Simvastatin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SIMVASTATIN 80 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination AGG2FN16EV Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 5 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198211 Internal RxNorm lookup 200345 Internal RxNorm lookup 312961 Internal RxNorm lookup 312962 Internal RxNorm lookup 314231 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42571-080 SIMVASTATIN (SIMVASTATIN) TABLET [MICRO LABS LIMITED] 90400 Current NDC, Legacy NDC, 5 package rows 20230822_5c1c694c-4b08-469e-b538-08e69df06146.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 1 of 1 · 1 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 42571-080-05 42571008005 500 TABLET in 1 BOTTLE (42571-080-05) 500 tablet 2013-06-13 0000-00-00 No No Current 42571-080-10 42571008010 1000 TABLET in 1 BOTTLE (42571-080-10) 1000 tablet 2013-06-13 0000-00-00 No No Current 42571-080-30 42571008030 30 TABLET in 1 BOTTLE (42571-080-30) 30 tablet 2013-06-13 0000-00-00 No No Current 42571-080-60 42571008060 60 TABLET in 1 BOTTLE (42571-080-60) 60 tablet 2013-06-13 0000-00-00 No No Current 42571-080-90 42571008090 90 TABLET in 1 BOTTLE (42571-080-90) 90 tablet 2013-06-13 0000-00-00 No No Current