Home NDC 0093-7154 Simvastatin
Product NDC 0093-7154
11-digit product format 000937154
Labeler code 0093
Product ID 0093-7154_68c57a69-a821-44fb-a778-a91e2c1c5f5c
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 2006-06-27
Marketing end 2020-05-31
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 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 · 48 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 · 210 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 2026-08-18 06:07:40 2026-07 A076052-001 SIMVASTATIN 5MG TABLET / ORAL 2006-06-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076052-002 SIMVASTATIN 10MG TABLET / ORAL 2006-06-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076052-003 SIMVASTATIN 20MG TABLET / ORAL 2006-06-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076052-004 SIMVASTATIN 40MG TABLET / ORAL 2006-06-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076052-005 SIMVASTATIN 80MG TABLET / ORAL 2006-12-20 caaa826d4ba7…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…
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SIMVASTATIN ACTIVE INGREDIENT AGG2FN16EV SIMVASTATIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 9 SIMVASTATIN ACTIVE MOIETY AGG2FN16EV SIMVASTATIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 9 ASCORBIC ACID INACTIVE INGREDIENT PQ6CK8PD0R SIMVASTATIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 9 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U SIMVASTATIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 9 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SIMVASTATIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 9 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP SIMVASTATIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 9 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 SIMVASTATIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 9 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT SIMVASTATIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 9 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO SIMVASTATIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 9 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X SIMVASTATIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 9 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SIMVASTATIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 9 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A SIMVASTATIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 9 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ SIMVASTATIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 9 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP SIMVASTATIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 9 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 SIMVASTATIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 9 SIMVASTATIN ACTIVE INGREDIENT AGG2FN16EV SIMVASTATIN TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 2 SIMVASTATIN ACTIVE MOIETY AGG2FN16EV SIMVASTATIN TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 2 ASCORBIC ACID INACTIVE INGREDIENT PQ6CK8PD0R SIMVASTATIN TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 2 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U SIMVASTATIN TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SIMVASTATIN TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 2 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP SIMVASTATIN TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 2 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 SIMVASTATIN TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 2 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT SIMVASTATIN TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 2 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 SIMVASTATIN TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X SIMVASTATIN TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SIMVASTATIN TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 2 POLYETHYLENE GLYCOL 3350 INACTIVE INGREDIENT G2M7P15E5P SIMVASTATIN TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 2 POLYETHYLENE GLYCOL 4000 INACTIVE INGREDIENT 4R4HFI6D95 SIMVASTATIN TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ SIMVASTATIN TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP SIMVASTATIN TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 2 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 SIMVASTATIN TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 2 SIMVASTATIN ACTIVE INGREDIENT AGG2FN16EV SIMVASTATIN TABLET, FILM COATED [MEDVANTX, INC.] 1 SIMVASTATIN ACTIVE MOIETY AGG2FN16EV SIMVASTATIN TABLET, FILM COATED [MEDVANTX, INC.] 1 ASCORBIC ACID INACTIVE INGREDIENT PQ6CK8PD0R SIMVASTATIN TABLET, FILM COATED [MEDVANTX, INC.] 1 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U SIMVASTATIN TABLET, FILM COATED [MEDVANTX, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SIMVASTATIN TABLET, FILM COATED [MEDVANTX, INC.] 1 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP SIMVASTATIN TABLET, FILM COATED [MEDVANTX, INC.] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 SIMVASTATIN TABLET, FILM COATED [MEDVANTX, INC.] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT SIMVASTATIN TABLET, FILM COATED [MEDVANTX, INC.] 1 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 SIMVASTATIN TABLET, FILM COATED [MEDVANTX, INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X SIMVASTATIN TABLET, FILM COATED [MEDVANTX, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SIMVASTATIN TABLET, FILM COATED [MEDVANTX, INC.] 1 POLYETHYLENE GLYCOL 3350 INACTIVE INGREDIENT G2M7P15E5P SIMVASTATIN TABLET, FILM COATED [MEDVANTX, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ SIMVASTATIN TABLET, FILM COATED [MEDVANTX, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP SIMVASTATIN TABLET, FILM COATED [MEDVANTX, INC.] 1 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 SIMVASTATIN TABLET, FILM COATED [MEDVANTX, INC.] 1
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