Home NDC 50090-7780 Simvastatin
Product NDC 50090-7780
11-digit product format 500907780
Labeler code 50090
Product ID 50090-7780_aa7c94a1-096a-413d-bc54-6ff663e09ef7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Simvastatin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler A-S Medication Solutions
Application ANDA077691
Marketing category ANDA
Marketing start 2006-12-20
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 44 .
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 A077691-001 SIMVASTATIN SIMVASTATIN 5MG TABLET / ORAL AB 2006-12-20 A077691-002 SIMVASTATIN SIMVASTATIN 10MG TABLET / ORAL AB 2006-12-20 A077691-003 SIMVASTATIN SIMVASTATIN 20MG TABLET / ORAL AB 2006-12-20 A077691-004 SIMVASTATIN SIMVASTATIN 40MG TABLET / ORAL AB 2006-12-20 A077691-005 SIMVASTATIN SIMVASTATIN 80MG TABLET / ORAL AB 2006-12-20
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 · 220 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 2026-10-15 13:18:30 2026-09 A077691-001 SIMVASTATIN 5MG TABLET / ORAL AB 2006-12-20 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077691-002 SIMVASTATIN 10MG TABLET / ORAL AB 2006-12-20 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077691-003 SIMVASTATIN 20MG TABLET / ORAL AB 2006-12-20 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077691-004 SIMVASTATIN 40MG TABLET / ORAL AB 2006-12-20 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077691-005 SIMVASTATIN 80MG TABLET / ORAL AB 2006-12-20 c2088c7a36db…2026-09-14 22:38:34 2026-08 A077691-001 SIMVASTATIN 5MG TABLET / ORAL AB 2006-12-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077691-002 SIMVASTATIN 10MG TABLET / ORAL AB 2006-12-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077691-003 SIMVASTATIN 20MG TABLET / ORAL AB 2006-12-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077691-004 SIMVASTATIN 40MG TABLET / ORAL AB 2006-12-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077691-005 SIMVASTATIN 80MG TABLET / ORAL AB 2006-12-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077691-001 SIMVASTATIN 5MG TABLET / ORAL AB 2006-12-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077691-002 SIMVASTATIN 10MG TABLET / ORAL AB 2006-12-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077691-003 SIMVASTATIN 20MG TABLET / ORAL AB 2006-12-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077691-004 SIMVASTATIN 40MG TABLET / ORAL AB 2006-12-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077691-005 SIMVASTATIN 80MG TABLET / ORAL AB 2006-12-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077691-001 SIMVASTATIN 5MG TABLET / ORAL AB 2006-12-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077691-002 SIMVASTATIN 10MG TABLET / ORAL AB 2006-12-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077691-003 SIMVASTATIN 20MG TABLET / ORAL AB 2006-12-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077691-004 SIMVASTATIN 40MG TABLET / ORAL AB 2006-12-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077691-005 SIMVASTATIN 80MG TABLET / ORAL AB 2006-12-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077691-001 SIMVASTATIN 5MG TABLET / ORAL AB 2006-12-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077691-002 SIMVASTATIN 10MG TABLET / ORAL AB 2006-12-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077691-003 SIMVASTATIN 20MG TABLET / ORAL AB 2006-12-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077691-004 SIMVASTATIN 40MG TABLET / ORAL AB 2006-12-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077691-005 SIMVASTATIN 80MG TABLET / ORAL AB 2006-12-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077691-001 SIMVASTATIN 5MG TABLET / ORAL AB 2006-12-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077691-002 SIMVASTATIN 10MG TABLET / ORAL AB 2006-12-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077691-003 SIMVASTATIN 20MG TABLET / ORAL AB 2006-12-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077691-004 SIMVASTATIN 40MG TABLET / ORAL AB 2006-12-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077691-005 SIMVASTATIN 80MG TABLET / ORAL AB 2006-12-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077691-001 SIMVASTATIN 5MG TABLET / ORAL AB 2006-12-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077691-002 SIMVASTATIN 10MG TABLET / ORAL AB 2006-12-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077691-003 SIMVASTATIN 20MG TABLET / ORAL AB 2006-12-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077691-004 SIMVASTATIN 40MG TABLET / ORAL AB 2006-12-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077691-005 SIMVASTATIN 80MG TABLET / ORAL AB 2006-12-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077691-001 SIMVASTATIN 5MG TABLET / ORAL AB 2006-12-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077691-002 SIMVASTATIN 10MG TABLET / ORAL AB 2006-12-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077691-003 SIMVASTATIN 20MG TABLET / ORAL AB 2006-12-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077691-004 SIMVASTATIN 40MG TABLET / ORAL AB 2006-12-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077691-005 SIMVASTATIN 80MG TABLET / ORAL AB 2006-12-20 b8a1b40f171c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 6 · 220 observed states.
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 10 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 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 50090-7780-0 Simvastatin 90 in 1 BOTTLE TABLET, FILM COATED 90 1 50090-7780-1 Simvastatin 1000 in 1 BOTTLE TABLET, FILM COATED 1000 1
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 2 of 2 · 23 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 50090-7780-0 50090778000 90 TABLET, FILM COATED in 1 BOTTLE (50090-7780-0) 2025-11-20 No No Current 50090-7780-1 50090778001 1000 TABLET, FILM COATED in 1 BOTTLE (50090-7780-1) 2025-11-20 No No Current