Home NDC 65862-050-99 Simvastatin
Product NDC 65862-050
Requested package NDC 65862-050-99
11-digit product format 658620050
Labeler code 65862
Product ID 65862-050_854ac8f7-cca5-434c-a611-9c1752260d4a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Simvastatin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA077691
Marketing category ANDA
Marketing start 2006-12-20
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 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 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SIMVASTATIN 5 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 65862-050-00 Simvastatin 100 in 1 BOTTLE TABLET, FILM COATED 100 29 65862-050-01 Simvastatin 100 in 1 BOTTLE TABLET, FILM COATED 100 29 65862-050-26 Simvastatin 2500 in 1 BOTTLE TABLET, FILM COATED 2500 29 65862-050-30 Simvastatin 30 in 1 BOTTLE TABLET, FILM COATED 30 29 65862-050-45 Simvastatin 45 in 1 BOTTLE TABLET, FILM COATED 45 29 65862-050-90 Simvastatin 90 in 1 BOTTLE TABLET, FILM COATED 90 29 65862-050-99 Simvastatin 1000 in 1 BOTTLE TABLET, FILM COATED 1000 29
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SIMVASTATIN ACTIVE INGREDIENT AGG2FN16EV SIMVASTATIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 15 SIMVASTATIN ACTIVE MOIETY AGG2FN16EV SIMVASTATIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 15 ASCORBIC ACID INACTIVE INGREDIENT PQ6CK8PD0R SIMVASTATIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 15 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U SIMVASTATIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 15 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SIMVASTATIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 15 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP SIMVASTATIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 15 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 SIMVASTATIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 15 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT SIMVASTATIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 15 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P SIMVASTATIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 15 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 SIMVASTATIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 15 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 SIMVASTATIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 15 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X SIMVASTATIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 15 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SIMVASTATIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 15 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ SIMVASTATIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 15 TALC INACTIVE INGREDIENT 7SEV7J4R1U SIMVASTATIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 15 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP SIMVASTATIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 15 SIMVASTATIN ACTIVE INGREDIENT AGG2FN16EV SIMVASTATIN TABLET, FILM COATED [AVPAK] 1 SIMVASTATIN ACTIVE MOIETY AGG2FN16EV SIMVASTATIN TABLET, FILM COATED [AVPAK] 1 ASCORBIC ACID INACTIVE INGREDIENT PQ6CK8PD0R SIMVASTATIN TABLET, FILM COATED [AVPAK] 1 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U SIMVASTATIN TABLET, FILM COATED [AVPAK] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SIMVASTATIN TABLET, FILM COATED [AVPAK] 1 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP SIMVASTATIN TABLET, FILM COATED [AVPAK] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 SIMVASTATIN TABLET, FILM COATED [AVPAK] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT SIMVASTATIN TABLET, FILM COATED [AVPAK] 1 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P SIMVASTATIN TABLET, FILM COATED [AVPAK] 1 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 SIMVASTATIN TABLET, FILM COATED [AVPAK] 1 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 SIMVASTATIN TABLET, FILM COATED [AVPAK] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X SIMVASTATIN TABLET, FILM COATED [AVPAK] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SIMVASTATIN TABLET, FILM COATED [AVPAK] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ SIMVASTATIN TABLET, FILM COATED [AVPAK] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U SIMVASTATIN TABLET, FILM COATED [AVPAK] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP SIMVASTATIN TABLET, FILM COATED [AVPAK] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65862-050 SIMVASTATIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 28 Current NDC, Legacy NDC, 7 package rows 20240104_4724dbb4-3613-4e6a-948f-a43d34f97f06.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 65862-050-99 65862005099 1000 TABLET, FILM COATED in 1 BOTTLE (65862-050-99) 2006-12-20 0000-00-00 No No Current