FDA.reportPublic FDA data

NDC 0093-7155-56 - Simvastatin

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0093-7155
Requested NDC
0093-7155-56
Package NDCs from labels
0093-7155-98, 0093-7155-10, 0093-7155-31, 0093-7155-56
Manufacturer
Mylan Institutional Inc.
Effective date
2019-12-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Simvastatin - Mylan Institutional Inc.Mylan Institutional Inc.2019-12-30HUMAN PRESCRIPTION DRUG LABEL
Simvastatin - Teva Pharmaceuticals USA, Inc.Teva Pharmaceuticals USA, Inc.2019-04-30HUMAN PRESCRIPTION DRUG LABEL
Simvastatin - Preferred Pharmaceuticals, Inc.Preferred Pharmaceuticals, Inc.2019-04-30HUMAN PRESCRIPTION DRUG LABEL
Simvastatin - QPharma Inc | Teva Pharmaceuticals USA, Inc. | Denton Pharma, Inc.QPharma Inc | Teva Pharmaceuticals USA, Inc. | Denton Pharma, Inc.2019-01-09HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-7155-10EA - Each0093-7155cb88c5d5-3dff-4739-a791-3444c5c3fd7312012-07-24
0093-7155-19EA - Each0093-7155cef03fb2-0b7b-4122-a31f-4dad3ec956a712012-07-24
0093-7155-31EA - Each0093-7155a22e4778-beac-470b-81ed-63826b84815812017-07-07
0093-7155-56EA - Each0093-7155534e8129-ff4e-489a-b2db-e5af6762964112012-07-24
0093-7155-93EA - Each0093-715525f9b8f5-4779-4e9c-9592-49a685f2c08812012-07-24
0093-7155-98EA - Each0093-7155b5dbd687-146a-49e2-9d25-34a0188aaf9012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SIMVASTATINACTIVE INGREDIENTAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]2
SIMVASTATINACTIVE MOIETYAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]2
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RSIMVASTATIN TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]2
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2USIMVASTATIN TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USIMVASTATIN TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSIMVASTATIN TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SIMVASTATIN TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSIMVASTATIN TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]2
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6SIMVASTATIN TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSIMVASTATIN TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SIMVASTATIN TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]2
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PSIMVASTATIN TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]2
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95SIMVASTATIN TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSIMVASTATIN TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSIMVASTATIN TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]2
TRIACETININACTIVE INGREDIENTXHX3C3X673SIMVASTATIN TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]2

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 1 of 129 · 2,569 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
leader clearlaxPOLYETHYLENE GLYCOL 3350Cardinal Health 110, LLC. dba Leader812c59b0-e7ce-4c7a-91ed-e74b7b1b84be2026-09-22WarningsExact identifier
unii: G2M7P15E5P
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350L.N.K. International, Inc.bbc11078-73f7-4d27-b0d3-4d4ae5dae2402026-09-10WarningsExact identifier
unii: G2M7P15E5P
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
CLEARLAXPOLYETHYLENE GLYCOL 3350Amazon.com Services LLC7ed915ec-7e99-4e0e-aca0-20718987a88c2026-09-08WarningsExact identifier
unii: G2M7P15E5P
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
purelaxPOLYETHYLENE GLYCOL 3350CVS Pharmacyfc3b6006-a75a-41b3-9f0b-a3152df1363f2026-09-04WarningsExact identifier
unii: G2M7P15E5P
basic care clearlaxPOLYETHYLENE GLYCOL 3350Amazon.com Services LLC1ccb8604-34f6-4e1e-beed-eb81d6aa7aef2026-09-03WarningsExact identifier
unii: G2M7P15E5P
purelaxPOLYETHYLENE GLYCOL 3350CVS Pharmacy006a9eca-400f-47f5-bee5-facf7034043e2026-09-02WarningsExact identifier
unii: G2M7P15E5P
KrogerPOLYETHYLENE GLYCOL 3350KROGER COMPANYc56271ff-703a-40c4-840f-1962798c9e422026-09-02WarningsExact identifier
unii: G2M7P15E5P
gentle laxPOLYETHYLENE GLYCOL 3350Kroger Company0d820dcc-440a-4036-86e9-fdb30cac95732026-09-01WarningsExact identifier
unii: G2M7P15E5P
ezetimibe and simvastatinEZETIMIBE AND SIMVASTATINNORTHSTAR RX LLC52a46269-2262-4052-a3ff-5455523f591f2026-09-01Warnings, Adverse reactionsExact identifier
unii: AGG2FN16EV
CLEARLAXPOLYETHYLENE GLYCOL 3350Amazon.com Services LLCbd33463b-eb1a-41ed-92d1-f50d0923eb3b2026-08-31WarningsExact identifier
unii: G2M7P15E5P
SIMVASTATINSIMVASTATINPreferred Pharmaceuticals, Inc.68f6c856-ea98-4872-b4df-a6e9e70444fc2026-08-31Warnings, Adverse reactionsExact identifier
unii: AGG2FN16EV
SIMVASTATINSIMVASTATINPreferred Pharmaceuticals, Inc.3f6fad0b-0278-433f-86db-761b673a58032026-08-31Warnings, Adverse reactionsExact identifier
unii: AGG2FN16EV
SIMVASTATINSIMVASTATINPreferred Pharmaceuticals, Inc.e73ec981-e477-4412-befd-7b807aceb32e2026-08-31Warnings, Adverse reactionsExact identifier
unii: AGG2FN16EV
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350Cardinal Health 107, LLC4d524ace-9de5-4f62-9263-7cd88a36b67c2026-08-28WarningsExact identifier
unii: G2M7P15E5P
PEG3350POLYETHYLENE GLYCOL 3350Major Pharmaceuticals161629f6-6193-4712-bba7-7d5b174a93382026-08-28WarningsExact identifier
unii: G2M7P15E5P
CalamineFERRIC OXIDE REDYour Military Exchangesaf95a66c-f063-4019-80c6-6f7dc4fee4d82026-08-28Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
SimvastatinSIMVASTATINREMEDYREPACK INC.593f0007-9690-4de5-b1e9-59299e5876432026-08-27Warnings, Adverse reactionsExact identifier
unii: AGG2FN16EV
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.