Home NDC 72189-421 Simvastatin
Product NDC 72189-421
11-digit product format 721890421
Labeler code 72189
Product ID 72189-421_2c4cfec2-fee2-e007-e063-6294a90a3cf9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Simvastatin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Direct_Rx
Application ANDA078103
Marketing category ANDA
Marketing start 2023-02-07
Substance SIMVASTATIN
Active strength 20 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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 72189-421-90 ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 72189-421-30 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 72189-421-90 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 72189-421-30 0efc9e666f02…f202fb6c5f17…
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 A078103-001 SIMVASTATIN SIMVASTATIN 10MG TABLET / ORAL AB 2007-05-11 A078103-002 SIMVASTATIN SIMVASTATIN 20MG TABLET / ORAL AB 2007-05-11 A078103-003 SIMVASTATIN SIMVASTATIN 40MG TABLET / ORAL AB 2007-05-11 A078103-004 SIMVASTATIN SIMVASTATIN 80MG TABLET / ORAL AB RS 2007-05-11 A078103-005 SIMVASTATIN SIMVASTATIN 5MG TABLET / ORAL AB 2009-04-14
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 A078103-001 SIMVASTATIN 10MG TABLET / ORAL AB 2007-05-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078103-002 SIMVASTATIN 20MG TABLET / ORAL AB 2007-05-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078103-003 SIMVASTATIN 40MG TABLET / ORAL AB 2007-05-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078103-004 SIMVASTATIN 80MG TABLET / ORAL AB RS 2007-05-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078103-005 SIMVASTATIN 5MG TABLET / ORAL AB 2009-04-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078103-001 SIMVASTATIN 10MG TABLET / ORAL AB 2007-05-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078103-002 SIMVASTATIN 20MG TABLET / ORAL AB 2007-05-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078103-003 SIMVASTATIN 40MG TABLET / ORAL AB 2007-05-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078103-004 SIMVASTATIN 80MG TABLET / ORAL AB RS 2007-05-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078103-005 SIMVASTATIN 5MG TABLET / ORAL AB 2009-04-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078103-001 SIMVASTATIN 10MG TABLET / ORAL AB 2007-05-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078103-002 SIMVASTATIN 20MG TABLET / ORAL AB 2007-05-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078103-003 SIMVASTATIN 40MG TABLET / ORAL AB 2007-05-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078103-004 SIMVASTATIN 80MG TABLET / ORAL AB RS 2007-05-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078103-005 SIMVASTATIN 5MG TABLET / ORAL AB 2009-04-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078103-001 SIMVASTATIN 10MG TABLET / ORAL AB 2007-05-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078103-002 SIMVASTATIN 20MG TABLET / ORAL AB 2007-05-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078103-003 SIMVASTATIN 40MG TABLET / ORAL AB 2007-05-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078103-004 SIMVASTATIN 80MG TABLET / ORAL AB RS 2007-05-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078103-005 SIMVASTATIN 5MG TABLET / ORAL AB 2009-04-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078103-001 SIMVASTATIN 10MG TABLET / ORAL AB 2007-05-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078103-002 SIMVASTATIN 20MG TABLET / ORAL AB 2007-05-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078103-003 SIMVASTATIN 40MG TABLET / ORAL AB 2007-05-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078103-004 SIMVASTATIN 80MG TABLET / ORAL AB RS 2007-05-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078103-005 SIMVASTATIN 5MG TABLET / ORAL AB 2009-04-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078103-001 SIMVASTATIN 10MG TABLET / ORAL AB 2007-05-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078103-002 SIMVASTATIN 20MG TABLET / ORAL AB 2007-05-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078103-003 SIMVASTATIN 40MG TABLET / ORAL AB 2007-05-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078103-004 SIMVASTATIN 80MG TABLET / ORAL AB RS 2007-05-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078103-005 SIMVASTATIN 5MG TABLET / ORAL AB 2009-04-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078103-001 SIMVASTATIN 10MG TABLET / ORAL AB 2007-05-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078103-002 SIMVASTATIN 20MG TABLET / ORAL AB 2007-05-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078103-003 SIMVASTATIN 40MG TABLET / ORAL AB 2007-05-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078103-004 SIMVASTATIN 80MG TABLET / ORAL AB RS 2007-05-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078103-005 SIMVASTATIN 5MG TABLET / ORAL AB 2009-04-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078103-001 SIMVASTATIN 10MG TABLET / ORAL AB 2007-05-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078103-002 SIMVASTATIN 20MG TABLET / ORAL AB 2007-05-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078103-003 SIMVASTATIN 40MG TABLET / ORAL AB 2007-05-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078103-004 SIMVASTATIN 80MG TABLET / ORAL AB RS 2007-05-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078103-005 SIMVASTATIN 5MG TABLET / ORAL AB 2009-04-14 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 20 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 312961 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 72189-421-30 Simvastatin 30 in 1 BOTTLE TABLET, FILM COATED 30 4 72189-421-90 Simvastatin 90 in 1 BOTTLE TABLET, FILM COATED 90 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72189-421 SIMVASTATIN TABLET, FILM COATED [DIRECT_RX] 4 Current NDC, 2 package rows 20250123_f42246de-62d2-212f-e053-2a95a90ac88a.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 3 of 3 · 45 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 72189-421-30 72189042130 30 TABLET, FILM COATED in 1 BOTTLE (72189-421-30) 2023-02-07 No No Current 72189-421-90 72189042190 90 TABLET, FILM COATED in 1 BOTTLE (72189-421-90) 2023-02-07 No No Current