NDC 48433-311-01 - 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: 48433-311
Requested NDC: 48433-311-01
Package NDCs from labels: 48433-311-01, 48433-311-10
Manufacturer: Safecor Health, LLC
Effective date: 2014-04-03
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Simvastatin - Safecor Health, LLC	Safecor Health, LLC	2014-04-03	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SIMVASTATIN	ACTIVE INGREDIENT	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [SAFECOR HEALTH, LLC]	1
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [SAFECOR HEALTH, LLC]	1
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [SAFECOR HEALTH, LLC]	1
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET, FILM COATED [SAFECOR HEALTH, LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMVASTATIN TABLET, FILM COATED [SAFECOR HEALTH, LLC]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SIMVASTATIN TABLET, FILM COATED [SAFECOR HEALTH, LLC]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SIMVASTATIN TABLET, FILM COATED [SAFECOR HEALTH, LLC]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	SIMVASTATIN TABLET, FILM COATED [SAFECOR HEALTH, LLC]	1
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	SIMVASTATIN TABLET, FILM COATED [SAFECOR HEALTH, LLC]	1
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	SIMVASTATIN TABLET, FILM COATED [SAFECOR HEALTH, LLC]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	SIMVASTATIN TABLET, FILM COATED [SAFECOR HEALTH, LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SIMVASTATIN TABLET, FILM COATED [SAFECOR HEALTH, LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SIMVASTATIN TABLET, FILM COATED [SAFECOR HEALTH, LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SIMVASTATIN TABLET, FILM COATED [SAFECOR HEALTH, LLC]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SIMVASTATIN TABLET, FILM COATED [SAFECOR HEALTH, LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SIMVASTATIN TABLET, FILM COATED [SAFECOR HEALTH, LLC]	1

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 44 of 152 · 3,039 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ALMOST powder MAKEUP BROAD SPECTRUM SPF 18	OCTINOXATE AND TITANIUM DIOXIDE	CLINIQUE LABORATORIES LLC	402add6d-a81e-4c9e-aee1-4abeb480894f	2025-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
HEB 70 Isopropyl Alcohol Wipes	ISOPROPYL ALCOHOL	HEB Grocery Company	e8dd7f84-3690-4ab3-a21f-43bf66984f4b	2025-12-30	Warnings	Exact identifier unii: ND2M416302
Perfect Glow BB Cream Sunscreen SPF 30 - Fair	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	472f4f34-99bc-2ff6-e063-6294a90a33c9	2025-12-30	Warnings	Exact identifier unii: 15FIX9V2JP
Perfect Glow BB Cream Sunscreen SPF 30 - Light Medium	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	47313277-8884-70b5-e063-6394a90a5fca	2025-12-30	Warnings	Exact identifier unii: 15FIX9V2JP
Perfect Glow BB Cream Sunscreen SPF 30 - Medium	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	47320858-0aea-6ee9-e063-6294a90a9fa9	2025-12-30	Warnings	Exact identifier unii: 15FIX9V2JP
Perfect Glow BB Cream Sunscreen SPF 30 - Light Warm	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	47325530-b097-db9a-e063-6294a90a335d	2025-12-30	Warnings	Exact identifier unii: 15FIX9V2JP
Perfect Glow BB Cream Sunscreen SPF 30 - Tan	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	47328eb4-8ad7-28b5-e063-6294a90a20b1	2025-12-30	Warnings	Exact identifier unii: 15FIX9V2JP
Perfect Glow BB Cream Sunscreen SPF 30 - Tan Deep	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	4732bbec-d9f9-1639-e063-6394a90aff82	2025-12-30	Warnings	Exact identifier unii: 15FIX9V2JP
Perfect Glow BB Cream Sunscreen SPF 30 - Deep	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	4732ecd0-5261-7f11-e063-6394a90a26f3	2025-12-30	Warnings	Exact identifier unii: 15FIX9V2JP
Ageless Glow Serum BB Cream Sunscreen SPF 40 - Fair	HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	473738b4-7c36-8edf-e063-6394a90ad24b	2025-12-30	Warnings	Exact identifier unii: 15FIX9V2JP
Ageless Glow Serum BB Cream Sunscreen SPF 40 - Medium Tan	HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	47387d5f-e77b-5633-e063-6294a90a5584	2025-12-30	Warnings	Exact identifier unii: 15FIX9V2JP
Ageless Glow Serum BB Cream Sunscreen SPF 40 - Tan	HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	4738be66-0fe8-148e-e063-6394a90a1b02	2025-12-30	Warnings	Exact identifier unii: 15FIX9V2JP
Ageless Glow Serum BB Cream Sunscreen SPF 40 - Tan Deep	HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	4738eed1-9f72-5fd8-e063-6394a90a26bd	2025-12-30	Warnings	Exact identifier unii: 15FIX9V2JP
Ageless Glow Serum BB Cream Sunscreen SPF 40 - Deep	HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	4739179e-88b3-8820-e063-6394a90aa211	2025-12-30	Warnings	Exact identifier unii: 15FIX9V2JP
Gestyra	ASCORBIC ACID, CHOLECALCIFEROL, THIAMINE, PYRIDOXAL PHOSPHATE, FOLIC ACID, METHYLCOBALAMIN, CALCIUM CARBONATE, FERROUS GLUCONATE, POTASSIUM IODIDE	Oncora Pharma LLC	f10bf225-c125-4711-893a-78e15be815bb	2025-12-30	Warnings	Exact identifier unii: PQ6CK8PD0R
TRICON	TRICON	Nnodum Pharmaceuticals	d891ab47-4a05-4b5b-b372-7ddf91699c29	2025-12-29	Adverse reactions	Exact identifier unii: PQ6CK8PD0R
SPF 30 Sunscreen	ZINC OXIDE, TITANIUM DIOXIDE	CLEURE	f5512f34-08ee-b0f6-e053-2a95a90ab5bd	2025-12-29	Warnings	Exact identifier unii: 15FIX9V2JP
RE-NUTRIV ULTRA RADIANCE MAKEUP BROAD SPECTRUM SPF 20	OCTINOXATE AND TITANIUM DIOXIDE	ESTEE LAUDER INC	897b8edb-f089-4a49-baca-e05806b0a068	2025-12-29	Warnings	Exact identifier unii: 15FIX9V2JP
OI LIN SUNMILK SUNSCREEN SPF 30	SUNSCREEN, TITANIUM DIOXIDE	Sunrider Manufacturing L.P.	26b57314-1616-4ca4-b65f-a363c525b432	2025-12-29	Warnings	Exact identifier unii: 15FIX9V2JP
Medicated Cornstarch Baby Powder	ACTIVE CORN STARCH	Davion, Inc.	e39032d1-c8cd-4a41-af10-126970b8ad38	2025-12-29	Warnings	Exact identifier unii: O8232NY3SJ

Reported adverse events (FAERS/openFDA)#

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