Home NDC 55111-197-01 Simvastatin
Product NDC 55111-197
Requested package NDC 55111-197-01
11-digit product format 551110197
Labeler code 55111
Product ID 55111-197_84334c5d-1663-972c-5d96-03eb1be16f64
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Simvastatin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Dr. Reddy's Laboratories Limited
Application ANDA078425
Marketing category ANDA
Marketing start 2007-08-16
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 2020-12-31
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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 55111-197 55111-197-01 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 55111-197 55111-197-01 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog .
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 [DR. REDDY'S LABORATORIES LIMITED] 9 Simvastatin ACTIVE MOIETY AGG2FN16EV SIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 9 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL SIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 9 ascorbic acid INACTIVE INGREDIENT PQ6CK8PD0R SIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 9 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U SIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 9 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 9 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 SIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 9 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT SIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 9 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 SIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 9 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P SIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 9 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO SIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 9 isopropyl alcohol INACTIVE INGREDIENT ND2M416302 SIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 9 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X SIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 9 magnesium stearate INACTIVE INGREDIENT 70097M6I30 SIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 9 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ SIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 9 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP SIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 9 SIMVASTATIN ACTIVE INGREDIENT AGG2FN16EV SIMVASTATIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 SIMVASTATIN ACTIVE MOIETY AGG2FN16EV SIMVASTATIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL SIMVASTATIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 ASCORBIC ACID INACTIVE INGREDIENT PQ6CK8PD0R SIMVASTATIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U SIMVASTATIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SIMVASTATIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 SIMVASTATIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT SIMVASTATIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 SIMVASTATIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P SIMVASTATIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO SIMVASTATIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 SIMVASTATIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X SIMVASTATIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SIMVASTATIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ SIMVASTATIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP SIMVASTATIN TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 Simvastatin ACTIVE INGREDIENT AGG2FN16EV SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 1 Simvastatin ACTIVE MOIETY AGG2FN16EV SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 1 ascorbic acid INACTIVE INGREDIENT PQ6CK8PD0R SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 1 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 1 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 1 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 1 isopropyl alcohol INACTIVE INGREDIENT ND2M416302 SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 1 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 1 magnesium stearate INACTIVE INGREDIENT 70097M6I30 SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 1 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP SIMVASTATIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55111-197 SIMVASTATIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 14 Legacy NDC 20190312_d9a1a7c5-d806-4dbd-a201-5e73790d078b.zip
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 55111-197-01 55111019701 100 TABLET, FILM COATED in 1 BOTTLE (55111-197-01) 2007-08-16 0000-00-00 No No Current