Home NDC 42571-010-60 Simvastatin
Product NDC 42571-010
Requested package NDC 42571-010-60
11-digit product format 425710010
Labeler code 42571
Product ID 42571-010_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 10 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 42 .
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 · 210 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 2026-08-18 06:07:40 2026-07 A090383-001 SIMVASTATIN 5MG TABLET / ORAL AB 2011-09-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090383-002 SIMVASTATIN 10MG TABLET / ORAL AB 2011-09-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090383-003 SIMVASTATIN 20MG TABLET / ORAL AB 2011-09-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090383-004 SIMVASTATIN 40MG TABLET / ORAL AB 2011-09-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090383-005 SIMVASTATIN 80MG TABLET / ORAL AB 2011-09-16 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 6 · 210 observed states.
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 42571-010 SIMVASTATIN (SIMVASTATIN) TABLET [MICRO LABS LIMITED] 90400 Current NDC, Legacy NDC, 5 package rows 20230822_5c1c694c-4b08-469e-b538-08e69df06146.zip
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 42571-010-60 42571001060 60 TABLET in 1 BOTTLE (42571-010-60) 60 tablet 2013-06-13 0000-00-00 No No Current