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 42 of 152 · 3,039 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SIMVASTATIN	SIMVASTATIN	Northwind Health Company, LLC	f835af8f-7d84-1978-e053-6294a90a22ae	2026-01-01	Warnings, Adverse reactions	Exact identifier rxcui: 198211 unii: AGG2FN16EV
Simvastatin	SIMVASTATIN	Northwind Health Company, LLC	f68e9cf8-a63f-1d64-e053-2a95a90a4923	2026-01-01	Warnings, Adverse reactions	Exact identifier rxcui: 198211 unii: AGG2FN16EV
Simvastatin	SIMVASTATIN	Northwind Health Company, LLC	f2f5ee7a-4f4e-12e9-e053-2a95a90a7eae	2026-01-01	Warnings, Adverse reactions	Exact identifier rxcui: 312961 unii: AGG2FN16EV
SIMVASTATIN	SIMVASTATIN	Northwind Health Company, LLC	f86de805-e4ec-4bca-e053-6294a90a1fc3	2026-01-01	Warnings, Adverse reactions	Exact identifier rxcui: 312961 unii: AGG2FN16EV
SIMVASTATIN	SIMVASTATIN	Proficient Rx LP	8e686832-1caf-425c-9ca6-7eaade43b6fe	2026-01-01	Warnings, Adverse reactions	Exact identifier rxcui: 312961 unii: AGG2FN16EV
ALCOHOL PREP PADS MEDIUM STERILE	ISOPROPYL ALCOHOL CLOTH	JINHUA JINGDI MEDICAL SUPPLIES CO., LTD	46c30329-e8b8-a123-e063-6394a90a85be	2025-12-31	Warnings	Exact identifier unii: ND2M416302
Youth Glow Vitamin C CC Cream Sunscreen SPF 50 - Fair	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	47428cd4-fbad-ba7a-e063-6394a90a1c5c	2025-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
Youth Glow Vitamin C CC Cream Sunscreen SPF 50 - Medium	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	47433a62-91e0-b031-e063-6294a90a0d49	2025-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - Fair	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	4743b6a9-4d79-1b2b-e063-6394a90a9710	2025-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - Light Medium	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	4744e501-f12a-6d25-e063-6394a90a2574	2025-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - Medium	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	47456bf5-9f6c-e6a5-e063-6294a90a7054	2025-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - Tan	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	4745ab56-abaa-42de-e063-6394a90a6310	2025-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - Tan Deep	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	4745ebec-acb0-77c4-e063-6394a90aee07	2025-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - Deep	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	47461ad3-a11e-2a11-e063-6294a90a0f8f	2025-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
Dermagesic	PRAMOXINE HCL, ZINC OXIDE, CALAMINE	Llorens Pharmaceutical International Division	bbff6b53-29da-45c1-8ccd-3e9df7f250e0	2025-12-31	Warnings	Exact identifier unii: 1K09F3G675
Sei Bella CC Brightening Creme Light	OCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1%	Melaleuca Inc.	6894b9d9-a5b5-4c98-e053-2991aa0a9ca2	2025-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
Sei Bella CC Brightening Creme Fair	OCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1%	Melaleuca Inc.	6892952a-d032-30bf-e053-2a91aa0a3bba	2025-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
Sei Bella CC Brightening Creme Medium Tan	OCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1%	Melaleuca Inc.	68a4e8b4-36cb-6306-e053-2a91aa0a6d25	2025-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
Sei Bella CC Brightening Creme Medium	OCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1%	Melaleuca Inc.	68a4ed34-f492-67a6-e053-2a91aa0a0428	2025-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
Sei Bella Daily UV Defense Broad-Spectrum SPF 25 Sunscreen	SUNSCREEN	Melaleuca Inc.	1f1d1575-cf37-5d66-e063-6394a90ab2a3	2025-12-31	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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