Home NDC 43353-875 Simvastatin
Product NDC 43353-875
11-digit product format 433530875
Labeler code 43353
Product ID 43353-875_68513fbe-c3f6-42f4-8358-589aad365109
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Simvastatin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA077691
Marketing category ANDA
Marketing start 2006-12-20
Marketing end 0000-00-00
Substance SIMVASTATIN
Active strength 5 mg/1
Pharmacologic classes HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2019-12-31
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 43 .
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 · 215 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 2026-09-14 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…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077691-001 SIMVASTATIN 5MG TABLET / ORAL AB 2006-12-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077691-002 SIMVASTATIN 10MG TABLET / ORAL AB 2006-12-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077691-003 SIMVASTATIN 20MG TABLET / ORAL AB 2006-12-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077691-004 SIMVASTATIN 40MG TABLET / ORAL AB 2006-12-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077691-005 SIMVASTATIN 80MG TABLET / ORAL AB 2006-12-20 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 6 · 215 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43353-875-30 Simvastatin 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 2 43353-875-60 Simvastatin 90 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 90 2 43353-875-88 Simvastatin 900 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 900 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SIMVASTATIN ACTIVE INGREDIENT AGG2FN16EV SIMVASTATIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 SIMVASTATIN ACTIVE MOIETY AGG2FN16EV SIMVASTATIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 ASCORBIC ACID INACTIVE INGREDIENT PQ6CK8PD0R SIMVASTATIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U SIMVASTATIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SIMVASTATIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP SIMVASTATIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 SIMVASTATIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT SIMVASTATIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P SIMVASTATIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 SIMVASTATIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 SIMVASTATIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X SIMVASTATIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SIMVASTATIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ SIMVASTATIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U SIMVASTATIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP SIMVASTATIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43353-875 SIMVASTATIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 Legacy NDC, 3 package rows 20191224_1d7c107b-64f3-41b0-88c5-4f38dc58ceaf.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 2 of 2 · 23 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 43353-875-30 43353087530 30 in 1 BOTTLE, PLASTIC Historical 43353-875-60 43353087560 90 in 1 BOTTLE, PLASTIC Historical 43353-875-88 43353087588 900 in 1 BOTTLE, PLASTIC Historical