Home NDC 69367-377-10 Simvastatin
Product NDC 69367-377
Requested package NDC 69367-377-10
11-digit product format 693670377
Labeler code 69367
Product ID 69367-377_5bcccfd7-0ae8-4fad-a535-5efa7b327550
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Simvastatin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Westminster Pharmaceuticals, LLC
Application ANDA211394
Marketing category ANDA
Marketing start 2025-04-14
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 43 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211394-001 SIMVASTATIN SIMVASTATIN 10MG TABLET / ORAL AB 2024-11-27 A211394-002 SIMVASTATIN SIMVASTATIN 20MG TABLET / ORAL AB 2024-11-27 A211394-003 SIMVASTATIN SIMVASTATIN 40MG TABLET / ORAL AB 2024-11-27 A211394-004 SIMVASTATIN SIMVASTATIN 80MG TABLET / ORAL AB 2024-11-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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.
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 2026-09-14 22:38:34 2026-08 A211394-001 SIMVASTATIN 10MG TABLET / ORAL AB 2024-11-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211394-002 SIMVASTATIN 20MG TABLET / ORAL AB 2024-11-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211394-003 SIMVASTATIN 40MG TABLET / ORAL AB 2024-11-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211394-004 SIMVASTATIN 80MG TABLET / ORAL AB 2024-11-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 A211394-001 SIMVASTATIN 10MG TABLET / ORAL AB 2024-11-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211394-002 SIMVASTATIN 20MG TABLET / ORAL AB 2024-11-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211394-003 SIMVASTATIN 40MG TABLET / ORAL AB 2024-11-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211394-004 SIMVASTATIN 80MG TABLET / ORAL AB 2024-11-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211394-001 SIMVASTATIN 10MG TABLET / ORAL AB 2024-11-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211394-002 SIMVASTATIN 20MG TABLET / ORAL AB 2024-11-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211394-003 SIMVASTATIN 40MG TABLET / ORAL AB 2024-11-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211394-004 SIMVASTATIN 80MG TABLET / ORAL AB 2024-11-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211394-001 SIMVASTATIN 10MG TABLET / ORAL AB 2024-11-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211394-002 SIMVASTATIN 20MG TABLET / ORAL AB 2024-11-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211394-003 SIMVASTATIN 40MG TABLET / ORAL AB 2024-11-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211394-004 SIMVASTATIN 80MG TABLET / ORAL AB 2024-11-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211394-001 SIMVASTATIN 10MG TABLET / ORAL AB 2024-11-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211394-002 SIMVASTATIN 20MG TABLET / ORAL AB 2024-11-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211394-003 SIMVASTATIN 40MG TABLET / ORAL AB 2024-11-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211394-004 SIMVASTATIN 80MG TABLET / ORAL AB 2024-11-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211394-001 SIMVASTATIN 10MG TABLET / ORAL AB 2024-11-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211394-002 SIMVASTATIN 20MG TABLET / ORAL AB 2024-11-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211394-003 SIMVASTATIN 40MG TABLET / ORAL AB 2024-11-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211394-004 SIMVASTATIN 80MG TABLET / ORAL AB 2024-11-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211394-001 SIMVASTATIN 10MG TABLET / ORAL AB 2024-11-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211394-002 SIMVASTATIN 20MG TABLET / ORAL AB 2024-11-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211394-003 SIMVASTATIN 40MG TABLET / ORAL AB 2024-11-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211394-004 SIMVASTATIN 80MG TABLET / ORAL AB 2024-11-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211394-001 SIMVASTATIN 10MG TABLET / ORAL AB 2024-11-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211394-002 SIMVASTATIN 20MG TABLET / ORAL AB 2024-11-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211394-003 SIMVASTATIN 40MG TABLET / ORAL AB 2024-11-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211394-004 SIMVASTATIN 80MG TABLET / ORAL AB 2024-11-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211394-001 SIMVASTATIN 10MG TABLET / ORAL AB 2024-11-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211394-002 SIMVASTATIN 20MG TABLET / ORAL AB 2024-11-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211394-003 SIMVASTATIN 40MG TABLET / ORAL AB 2024-11-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211394-004 SIMVASTATIN 80MG TABLET / ORAL AB 2024-11-27 2680178bc6a6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211394-001 SIMVASTATIN 10MG TABLET / ORAL AB 2024-11-27 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211394-002 SIMVASTATIN 20MG TABLET / ORAL AB 2024-11-27 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211394-003 SIMVASTATIN 40MG TABLET / ORAL AB 2024-11-27 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211394-004 SIMVASTATIN 80MG TABLET / ORAL AB 2024-11-27 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198211 Internal RxNorm lookup 200345 Internal RxNorm lookup 312961 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 69367-377-09 Simvastatin 90 in 1 BOTTLE TABLET, FILM COATED 90 2 69367-377-10 Simvastatin 1000 in 1 BOTTLE TABLET, FILM COATED 1000 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69367-377 SIMVASTATIN TABLET, FILM COATED [WESTMINSTER PHARMACEUTICALS, LLC] 1 Current NDC, 2 package rows 20250423_acaaab63-c9ff-44c9-8fde-9a4ea6454dd7.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 Marketing start Sample Exclude flag Status 69367-377-10 69367037710 1000 TABLET, FILM COATED in 1 BOTTLE (69367-377-10) 2025-04-14 No No Current