Home NDC 0093-7156 Simvastatin
Product NDC 0093-7156
11-digit product format 000937156
Labeler code 0093
Product ID 0093-7156_33687dff-291c-43fe-8567-6a35927682eb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Simvastatin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Teva Pharmaceuticals USA, Inc.
Application ANDA076052
Marketing category ANDA
Marketing start 2006-12-20
Marketing end 2019-10-31
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 0000-00-00
Current FDA listing Historical FDA.report record 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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A076052-001 SIMVASTATIN SIMVASTATIN 5MG TABLET / ORAL 2006-06-23 A076052-002 SIMVASTATIN SIMVASTATIN 10MG TABLET / ORAL 2006-06-23 A076052-003 SIMVASTATIN SIMVASTATIN 20MG TABLET / ORAL 2006-06-23 A076052-004 SIMVASTATIN SIMVASTATIN 40MG TABLET / ORAL 2006-06-23 A076052-005 SIMVASTATIN SIMVASTATIN 80MG TABLET / ORAL 2006-12-20
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 A076052-001 SIMVASTATIN 5MG TABLET / ORAL 2006-06-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076052-002 SIMVASTATIN 10MG TABLET / ORAL 2006-06-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076052-003 SIMVASTATIN 20MG TABLET / ORAL 2006-06-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076052-004 SIMVASTATIN 40MG TABLET / ORAL 2006-06-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076052-005 SIMVASTATIN 80MG TABLET / ORAL 2006-12-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076052-001 SIMVASTATIN 5MG TABLET / ORAL 2006-06-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076052-002 SIMVASTATIN 10MG TABLET / ORAL 2006-06-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076052-003 SIMVASTATIN 20MG TABLET / ORAL 2006-06-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076052-004 SIMVASTATIN 40MG TABLET / ORAL 2006-06-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076052-005 SIMVASTATIN 80MG TABLET / ORAL 2006-12-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076052-001 SIMVASTATIN 5MG TABLET / ORAL 2006-06-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076052-002 SIMVASTATIN 10MG TABLET / ORAL 2006-06-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076052-003 SIMVASTATIN 20MG TABLET / ORAL 2006-06-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076052-004 SIMVASTATIN 40MG TABLET / ORAL 2006-06-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076052-005 SIMVASTATIN 80MG TABLET / ORAL 2006-12-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076052-001 SIMVASTATIN 5MG TABLET / ORAL 2006-06-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076052-002 SIMVASTATIN 10MG TABLET / ORAL 2006-06-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076052-003 SIMVASTATIN 20MG TABLET / ORAL 2006-06-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076052-004 SIMVASTATIN 40MG TABLET / ORAL 2006-06-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076052-005 SIMVASTATIN 80MG TABLET / ORAL 2006-12-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076052-001 SIMVASTATIN 5MG TABLET / ORAL 2006-06-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076052-002 SIMVASTATIN 10MG TABLET / ORAL 2006-06-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076052-003 SIMVASTATIN 20MG TABLET / ORAL 2006-06-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076052-004 SIMVASTATIN 40MG TABLET / ORAL 2006-06-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076052-005 SIMVASTATIN 80MG TABLET / ORAL 2006-12-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076052-001 SIMVASTATIN 5MG TABLET / ORAL 2006-06-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076052-002 SIMVASTATIN 10MG TABLET / ORAL 2006-06-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076052-003 SIMVASTATIN 20MG TABLET / ORAL 2006-06-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076052-004 SIMVASTATIN 40MG TABLET / ORAL 2006-06-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076052-005 SIMVASTATIN 80MG TABLET / ORAL 2006-12-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076052-001 SIMVASTATIN 5MG TABLET / ORAL 2006-06-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076052-002 SIMVASTATIN 10MG TABLET / ORAL 2006-06-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076052-003 SIMVASTATIN 20MG TABLET / ORAL 2006-06-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076052-004 SIMVASTATIN 40MG TABLET / ORAL 2006-06-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076052-005 SIMVASTATIN 80MG TABLET / ORAL 2006-12-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076052-001 SIMVASTATIN 5MG TABLET / ORAL 2006-06-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076052-002 SIMVASTATIN 10MG TABLET / ORAL 2006-06-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076052-003 SIMVASTATIN 20MG TABLET / ORAL 2006-06-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076052-004 SIMVASTATIN 40MG TABLET / ORAL 2006-06-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076052-005 SIMVASTATIN 80MG TABLET / ORAL 2006-12-20 5bbf6a4d5a75…