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 17 of 154 · 3,079 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-DEEP	YOUR NAME MINERAL SHEER TINT	PML NYC, LLC	0e246e64-2eab-1219-e063-6294a90a79a8	2026-04-17	Warnings	Exact identifier unii: 15FIX9V2JP
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-FAIR GLOW	YOUR NAME MINERAL SHEER TINT	PML NYC, LLC	316cd8a3-3d62-83ac-e063-6394a90a4afa	2026-04-17	Warnings	Exact identifier unii: 15FIX9V2JP
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20- HONEY GLOW	YOUR NAME MINERAL SHEER TINT	PML NYC, LLC	0e2424f4-0011-42b0-e063-6394a90a780d	2026-04-17	Warnings	Exact identifier unii: 15FIX9V2JP
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-LIGHT	YOUR NAME MINERAL SHEER TINT	PML NYC, LLC	316cfaea-b71f-2956-e063-6294a90a4f20	2026-04-17	Warnings	Exact identifier unii: 15FIX9V2JP
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-MEDIUM	YOUR NAME MINERAL SHEER TINT	PML NYC, LLC	316d1515-6092-a7d6-e063-6394a90ab8b2	2026-04-17	Warnings	Exact identifier unii: 15FIX9V2JP
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20- MEDIUM DEEP	YOUR NAME MINERAL SHEER TINT	PML NYC, LLC	0e246e70-6ec3-5711-e063-6394a90a3879	2026-04-17	Warnings	Exact identifier unii: 15FIX9V2JP
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20	YOUR NAME MINERAL SHEER TINT	PML NYC, LLC	0e241343-db63-3f1c-e063-6394a90ab538	2026-04-17	Warnings	Exact identifier unii: 15FIX9V2JP
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20	YOUR NAME MINERAL SHEER TINT	PML NYC, LLC	316df5fe-0574-d59f-e063-6294a90af8b9	2026-04-17	Warnings	Exact identifier unii: 15FIX9V2JP
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20- SUN GLOW	YOUR NAME MINERAL SHEER TINT	PML NYC, LLC	316c5d69-46f4-7677-e063-6294a90a610f	2026-04-17	Warnings	Exact identifier unii: 15FIX9V2JP
Sei Bella Tinted BB Moisturizing Cream	230 N	PML NYC, LLC	316ea01b-4bff-55be-e063-6394a90add94	2026-04-17	Warnings	Exact identifier unii: 15FIX9V2JP
Sei Bella Tinted BB Moisturizing Cream	410 N	PML NYC, LLC	316e97bc-4b96-ba6e-e063-6294a90a7648	2026-04-17	Warnings	Exact identifier unii: 15FIX9V2JP
EltaMD UV Restore Tinted	TITANIUM DIOXIDE AND ZINC OXIDE SUNSCREEN	CP Skin Health Group, Inc.	6a48ad0d-20e4-44b1-90d6-30bfbc68a152	2026-04-17	Warnings	Exact identifier unii: 15FIX9V2JP
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Medium)	TITANIUM DIOXIDE, ZINC OXIDE	ZO Skin Health Inc.	4f95cd0a-f996-648b-e063-6294a90adc28	2026-04-16	Warnings	Exact identifier unii: 15FIX9V2JP
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Tan)	TITANIUM DIOXIDE, ZINC OXIDE	ZO Skin Health Inc.	4f968058-e851-86d0-e063-6294a90aa786	2026-04-16	Warnings	Exact identifier unii: 15FIX9V2JP
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Deep)	TITANIUM DIOXIDE, ZINC OXIDE	ZO Skin Health Inc.	4f970778-97d6-40a9-e063-6394a90a6c89	2026-04-16	Warnings	Exact identifier unii: 15FIX9V2JP
SIMVASTATIN	SIMVASTATIN	Bryant Ranch Prepack	5c760852-800b-463e-8059-06a9a82c2225	2026-04-15	Warnings, Adverse reactions	Exact identifier rxcui: 312961 unii: AGG2FN16EV
MELAO Hydrating Mineral Sunscreen	TITANIUM DIOXIDE,ZINC OXIDE	Guangdong Aimu Biological Technology Co., Ltd	4f778eb0-55f7-38d0-e063-6394a90a69a0	2026-04-15	Warnings	Exact identifier unii: 15FIX9V2JP
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45	TITANIUM DIOXIDE, ZINC OXIDE	ZO Skin Health Inc.	4f81e482-8111-451c-e063-6294a90ad148	2026-04-15	Warnings	Exact identifier unii: 15FIX9V2JP
Mineral Lip Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	UNDRBUDR, LLC	4f8353b3-4ac1-9703-e063-6294a90abdad	2026-04-15	Warnings	Exact identifier unii: 15FIX9V2JP
Mineral Sunscreen Stick Non-Tinted	TITANIUM DIOXIDE, ZINC OXIDE	UNDRBUDR, LLC	4f83dd76-a8d8-916e-e063-6294a90ab6ed	2026-04-15	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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