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 87 of 152 · 3,023 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dolce and Gabbana Everlast Foundation SPF 20 08W Light	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	498bf941-67f2-41d5-a039-9f827b68297e	2025-08-05	Warnings	Exact identifier unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 10N Light Medium	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	54e390bd-b84a-4c43-986e-74923e34689d	2025-08-05	Warnings	Exact identifier unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 09C Light Medium	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	897024cd-576e-4a8e-8daa-92dc3bb4b3a5	2025-08-05	Warnings	Exact identifier unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 11W Light Medium	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	303967d1-9df8-4a8e-a264-6b0d8fdbf2a8	2025-08-05	Warnings	Exact identifier unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 12N Light Medium	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	26062cd7-3817-46c7-b65f-92cd57eca5dd	2025-08-05	Warnings	Exact identifier unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 13C Light Medium	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	448a24a3-91ef-4530-828c-e77d8aae7f0b	2025-08-05	Warnings	Exact identifier unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 02C Light	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	09f9e59b-6f71-4d42-9b5d-275f756d985b	2025-08-04	Warnings	Exact identifier unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 03W Light	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	3b1e4480-8409-425e-b98d-eb4dcf2471e8	2025-08-04	Warnings	Exact identifier unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 06W Light	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	3090422e-fc18-45b8-88f2-6a9b282a7205	2025-08-04	Warnings	Exact identifier unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 05N Light	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	f93aa5d2-90ab-4e11-874e-2ede4b25c4b6	2025-08-04	Warnings	Exact identifier unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 04C Light	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	f055cd51-7b1d-43df-8990-8f60ba1eb91c	2025-08-04	Warnings	Exact identifier unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 07N Light	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	d4c76bc5-205b-45fd-8a02-4f4b17458503	2025-08-04	Warnings	Exact identifier unii: 15FIX9V2JP
Caring Mill Alcohol Prep Pads	ISOPROPYL ALCOHOL	FSA Store Inc.	3b394791-0783-79e1-e063-6294a90ae8e7	2025-07-31	Warnings	Exact identifier unii: ND2M416302
Neutrogena Mineral Invisible Daily Defense Face Sunscreen Broad Spectrum SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Kenvue Brands LLC	003123d2-9675-fdd2-e063-6294a90a0130	2025-07-28	Warnings	Exact identifier unii: 15FIX9V2JP
Neutrogena Mineral Ultra Sheer Face SPF 70	TITANIUM DIOXIDE, ZINC OXIDE	Kenvue Brands LLC	20e0badf-fe25-1d27-e063-6294a90a7cfe	2025-07-28	Warnings	Exact identifier unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 01N Light	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	2ccf4e45-4cec-417d-9f4c-28f376025f1d	2025-07-25	Warnings	Exact identifier unii: 15FIX9V2JP
Sunscreen	TITANIUM DIOXIDE 6.8%	Baxter of California, LLC	146030bc-2bf4-25ea-e063-6294a90a4613	2025-07-24	Warnings	Exact identifier unii: 15FIX9V2JP
La Defense Broad Spectrum SPF 30 Mineral Sunscreen	ZINC OXIDE, TITANIUM DIOXIDE	Luzern Laboratories, Inc	3f00befa-415d-415d-89e1-6ba8770ba51e	2025-07-21	Warnings	Exact identifier unii: 15FIX9V2JP
Ezetimibe and Simvastatin	EZETIMIBE AND SIMVASTATIN	Dr.Reddys Laboratories Inc	023ca87a-1b04-8c17-dc4f-e2758b0771e2	2025-07-18	Warnings, Adverse reactions	Exact identifier unii: AGG2FN16EV
WISH 91% ISOPROPYL RUBBING ALCOHOL	ISOPROPYL ALCOHOL	LJ Pharma	449df7ac-97ac-41f3-a3c8-cf0d7c597e05	2025-07-17	Warnings	Exact identifier unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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