Home NDC 82009-012 Simvastatin
Product NDC 82009-012
11-digit product format 820090012
Labeler code 82009
Product ID 82009-012_1de47781-9000-0fc1-e063-6294a90a8139
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Simvastatin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Quallent Pharmaceuticals Health LLC
Application ANDA200895
Marketing category ANDA
Marketing start 2022-05-26
Substance SIMVASTATIN
Active strength 5 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 A200895-001 SIMVASTATIN SIMVASTATIN 5MG TABLET / ORAL AB 2014-11-25 A200895-002 SIMVASTATIN SIMVASTATIN 10MG TABLET / ORAL AB 2014-11-25 A200895-003 SIMVASTATIN SIMVASTATIN 20MG TABLET / ORAL AB 2014-11-25 A200895-004 SIMVASTATIN SIMVASTATIN 40MG TABLET / ORAL AB 2014-11-25 A200895-005 SIMVASTATIN SIMVASTATIN 80MG TABLET / ORAL AB 2014-11-25
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 A200895-001 SIMVASTATIN 5MG TABLET / ORAL AB 2014-11-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200895-002 SIMVASTATIN 10MG TABLET / ORAL AB 2014-11-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200895-003 SIMVASTATIN 20MG TABLET / ORAL AB 2014-11-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200895-004 SIMVASTATIN 40MG TABLET / ORAL AB 2014-11-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200895-005 SIMVASTATIN 80MG TABLET / ORAL AB 2014-11-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200895-001 SIMVASTATIN 5MG TABLET / ORAL AB 2014-11-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200895-002 SIMVASTATIN 10MG TABLET / ORAL AB 2014-11-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200895-003 SIMVASTATIN 20MG TABLET / ORAL AB 2014-11-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200895-004 SIMVASTATIN 40MG TABLET / ORAL AB 2014-11-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200895-005 SIMVASTATIN 80MG TABLET / ORAL AB 2014-11-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200895-001 SIMVASTATIN 5MG TABLET / ORAL AB 2014-11-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200895-002 SIMVASTATIN 10MG TABLET / ORAL AB 2014-11-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200895-003 SIMVASTATIN 20MG TABLET / ORAL AB 2014-11-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200895-004 SIMVASTATIN 40MG TABLET / ORAL AB 2014-11-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200895-005 SIMVASTATIN 80MG TABLET / ORAL AB 2014-11-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200895-001 SIMVASTATIN 5MG TABLET / ORAL AB 2014-11-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200895-002 SIMVASTATIN 10MG TABLET / ORAL AB 2014-11-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200895-003 SIMVASTATIN 20MG TABLET / ORAL AB 2014-11-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200895-004 SIMVASTATIN 40MG TABLET / ORAL AB 2014-11-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200895-005 SIMVASTATIN 80MG TABLET / ORAL AB 2014-11-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200895-001 SIMVASTATIN 5MG TABLET / ORAL AB 2014-11-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200895-002 SIMVASTATIN 10MG TABLET / ORAL AB 2014-11-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200895-003 SIMVASTATIN 20MG TABLET / ORAL AB 2014-11-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200895-004 SIMVASTATIN 40MG TABLET / ORAL AB 2014-11-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200895-005 SIMVASTATIN 80MG TABLET / ORAL AB 2014-11-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200895-001 SIMVASTATIN 5MG TABLET / ORAL AB 2014-11-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200895-002 SIMVASTATIN 10MG TABLET / ORAL AB 2014-11-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200895-003 SIMVASTATIN 20MG TABLET / ORAL AB 2014-11-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200895-004 SIMVASTATIN 40MG TABLET / ORAL AB 2014-11-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200895-005 SIMVASTATIN 80MG TABLET / ORAL AB 2014-11-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200895-001 SIMVASTATIN 5MG TABLET / ORAL AB 2014-11-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200895-002 SIMVASTATIN 10MG TABLET / ORAL AB 2014-11-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200895-003 SIMVASTATIN 20MG TABLET / ORAL AB 2014-11-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200895-004 SIMVASTATIN 40MG TABLET / ORAL AB 2014-11-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200895-005 SIMVASTATIN 80MG TABLET / ORAL AB 2014-11-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200895-001 SIMVASTATIN 5MG TABLET / ORAL AB 2014-11-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200895-002 SIMVASTATIN 10MG TABLET / ORAL AB 2014-11-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200895-003 SIMVASTATIN 20MG TABLET / ORAL AB 2014-11-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200895-004 SIMVASTATIN 40MG TABLET / ORAL AB 2014-11-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200895-005 SIMVASTATIN 80MG TABLET / ORAL AB 2014-11-25 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 5 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# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 82009-012-10 Simvastatin 1000 in 1 BOTTLE TABLET, FILM COATED 1000 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82009-012 SIMVASTATIN (SIMVASTATIN) TABLET, FILM COATED [QUALLENT PHARMACEUTICALS HEALTH LLC] 6 Current NDC, Legacy NDC, 1 package rows 20240724_2b4255a7-f9f5-4235-8dbb-b0f03acbd624.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 82009-012-10 82009001210 1000 TABLET, FILM COATED in 1 BOTTLE (82009-012-10) 2022-05-26 0000-00-00 No No Current 82009-012-90 82009001290 90 TABLET, FILM COATED in 1 BOTTLE (82009-012-90) 2022-05-26 0000-00-00 No No Current