Home NDC 16714-682 Simvastatin
Product NDC 16714-682
11-digit product format 167140682
Labeler code 16714
Product ID 16714-682_6c353eba-27f3-43cc-b954-ec659881872f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Simvastatin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler NorthStar Rx LLC
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 2027-12-31
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 · 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.
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 · 5 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198211 Internal RxNorm lookup 200345 Internal RxNorm lookup 312961 Internal RxNorm lookup 312962 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 16714-682-01 Simvastatin 30 in 1 BOTTLE TABLET, FILM COATED 30 24 16714-682-02 Simvastatin 90 in 1 BOTTLE TABLET, FILM COATED 90 24 16714-682-03 Simvastatin 1000 in 1 BOTTLE TABLET, FILM COATED 1000 24
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SIMVASTATIN ACTIVE INGREDIENT AGG2FN16EV SIMVASTATIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 10 SIMVASTATIN ACTIVE MOIETY AGG2FN16EV SIMVASTATIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 10 ASCORBIC ACID INACTIVE INGREDIENT PQ6CK8PD0R SIMVASTATIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 10 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U SIMVASTATIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 10 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SIMVASTATIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 10 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP SIMVASTATIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 10 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 SIMVASTATIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 10 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT SIMVASTATIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 10 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P SIMVASTATIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 10 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 SIMVASTATIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 10 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 SIMVASTATIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 10 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X SIMVASTATIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 10 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SIMVASTATIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 10 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ SIMVASTATIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 10 TALC INACTIVE INGREDIENT 7SEV7J4R1U SIMVASTATIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 10 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP SIMVASTATIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 10 SIMVASTATIN ACTIVE INGREDIENT AGG2FN16EV SIMVASTATIN TABLET, FILM COATED [NORTHSTAR RX LLC] 9 SIMVASTATIN ACTIVE MOIETY AGG2FN16EV SIMVASTATIN TABLET, FILM COATED [NORTHSTAR RX LLC] 9 ASCORBIC ACID INACTIVE INGREDIENT PQ6CK8PD0R SIMVASTATIN TABLET, FILM COATED [NORTHSTAR RX LLC] 9 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U SIMVASTATIN TABLET, FILM COATED [NORTHSTAR RX LLC] 9 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SIMVASTATIN TABLET, FILM COATED [NORTHSTAR RX LLC] 9 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP SIMVASTATIN TABLET, FILM COATED [NORTHSTAR RX LLC] 9 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 SIMVASTATIN TABLET, FILM COATED [NORTHSTAR RX LLC] 9 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT SIMVASTATIN TABLET, FILM COATED [NORTHSTAR RX LLC] 9 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P SIMVASTATIN TABLET, FILM COATED [NORTHSTAR RX LLC] 9 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 SIMVASTATIN TABLET, FILM COATED [NORTHSTAR RX LLC] 9 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 SIMVASTATIN TABLET, FILM COATED [NORTHSTAR RX LLC] 9 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X SIMVASTATIN TABLET, FILM COATED [NORTHSTAR RX LLC] 9 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SIMVASTATIN TABLET, FILM COATED [NORTHSTAR RX LLC] 9 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ SIMVASTATIN TABLET, FILM COATED [NORTHSTAR RX LLC] 9 TALC INACTIVE INGREDIENT 7SEV7J4R1U SIMVASTATIN TABLET, FILM COATED [NORTHSTAR RX LLC] 9 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP SIMVASTATIN TABLET, FILM COATED [NORTHSTAR RX LLC] 9 SIMVASTATIN ACTIVE INGREDIENT AGG2FN16EV SIMVASTATIN TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 3 SIMVASTATIN ACTIVE MOIETY AGG2FN16EV SIMVASTATIN TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 3 ASCORBIC ACID INACTIVE INGREDIENT PQ6CK8PD0R SIMVASTATIN TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 3 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U SIMVASTATIN TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SIMVASTATIN TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 3 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP SIMVASTATIN TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 3 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 SIMVASTATIN TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 3 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT SIMVASTATIN TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 3 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P SIMVASTATIN TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 3 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 SIMVASTATIN TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 3 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 SIMVASTATIN TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 3 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X SIMVASTATIN TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SIMVASTATIN TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ SIMVASTATIN TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 3 TALC INACTIVE INGREDIENT 7SEV7J4R1U SIMVASTATIN TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP SIMVASTATIN TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16714-682 SIMVASTATIN TABLET, FILM COATED [NORTHSTAR RX LLC] 24 Current NDC, Legacy NDC, 3 package rows 20240425_0376351b-f1a0-43e5-a0b4-533072c49f39.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 Marketing start Marketing end Sample Exclude flag Status 16714-682-01 16714068201 30 TABLET, FILM COATED in 1 BOTTLE (16714-682-01) 2006-12-20 0000-00-00 No No Current 16714-682-02 16714068202 90 TABLET, FILM COATED in 1 BOTTLE (16714-682-02) 2006-12-20 0000-00-00 No No Current 16714-682-03 16714068203 1000 TABLET, FILM COATED in 1 BOTTLE (16714-682-03) 2006-12-20 0000-00-00 No No Current