NDC 68084-512-11 - 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: 68084-512
Requested NDC: 68084-512-11
Package NDCs from labels: 68084-512-11, 68084-512-01
Manufacturer: Cardinal Health 107, LLC
Effective date: 2026-08-25
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Simvastatin - Cardinal Health 107, LLC	Cardinal Health 107, LLC	2026-08-25	HUMAN PRESCRIPTION DRUG LABEL
Simvastatin - American Health Packaging	American Health Packaging	2025-08-25	HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unit	National Council for Prescription Drug Programs	2012-07-24	Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68084-512-01	Simvastatin	100 in 1 BOX, UNIT-DOSE	TABLET, FILM COATED	100		13
68084-512-11	Simvastatin	1 in 1 BLISTER PACK	TABLET, FILM COATED	1		13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68084-512	SIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	12	Current NDC, Legacy NDC, 2 package rows	20241010_4bec3923-6221-4b8b-9a72-872a63680de1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68084-512-01	EA - Each	68084-512	8842de97-824e-43ff-8fd2-0f01507047d4	1	2012-07-24
68084-512-11	EA - Each	68084-512	0c80d024-7508-4287-ad49-aab17a212155	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SIMVASTATIN	ACTIVE INGREDIENT	AGG2FN16EV	SIMVASTATIN TABLET [CARDINAL HEALTH]	5
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET [CARDINAL HEALTH]	5
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET [CARDINAL HEALTH]	5
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET [CARDINAL HEALTH]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMVASTATIN TABLET [CARDINAL HEALTH]	5
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SIMVASTATIN TABLET [CARDINAL HEALTH]	5
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	SIMVASTATIN TABLET [CARDINAL HEALTH]	5
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	SIMVASTATIN TABLET [CARDINAL HEALTH]	5
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SIMVASTATIN TABLET [CARDINAL HEALTH]	5
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SIMVASTATIN TABLET [CARDINAL HEALTH]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SIMVASTATIN TABLET [CARDINAL HEALTH]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SIMVASTATIN TABLET [CARDINAL HEALTH]	5
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SIMVASTATIN TABLET [CARDINAL HEALTH]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SIMVASTATIN TABLET [CARDINAL HEALTH]	5
SIMVASTATIN	ACTIVE INGREDIENT	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	4
SIMVASTATIN	ACTIVE MOIETY	AGG2FN16EV	SIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	4
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	SIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	4
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	4
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	SIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	4
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	SIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	4
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	SIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	4

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 122 · 2,426 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Stay Ageless Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	W Aesthetics	5b0f2c8f-d6fa-5e25-e063-6394a90a084d	2026-09-09	Warnings	Exact identifier unii: 15FIX9V2JP
ezetimibe and simvastatin	EZETIMIBE AND SIMVASTATIN	NORTHSTAR RX LLC	52a46269-2262-4052-a3ff-5455523f591f	2026-09-01	Warnings, Adverse reactions	Exact identifier unii: AGG2FN16EV
SIMVASTATIN	SIMVASTATIN	Preferred Pharmaceuticals, Inc.	68f6c856-ea98-4872-b4df-a6e9e70444fc	2026-08-31	Warnings, Adverse reactions	Exact identifier application number: ANDA078103 rxcui: 200345 unii: AGG2FN16EV
SIMVASTATIN	SIMVASTATIN	Preferred Pharmaceuticals, Inc.	3f6fad0b-0278-433f-86db-761b673a5803	2026-08-31	Warnings, Adverse reactions	Exact identifier application number: ANDA078103 rxcui: 312961 unii: AGG2FN16EV
SIMVASTATIN	SIMVASTATIN	Preferred Pharmaceuticals, Inc.	e73ec981-e477-4412-befd-7b807aceb32e	2026-08-31	Warnings, Adverse reactions	Exact identifier application number: ANDA078103 rxcui: 314231 unii: AGG2FN16EV
Simvastatin	SIMVASTATIN	REMEDYREPACK INC.	593f0007-9690-4de5-b1e9-59299e587643	2026-08-27	Warnings, Adverse reactions	Exact identifier rxcui: 312962 unii: AGG2FN16EV
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50	SUNSCREEN SPF50	Guangzhou Meixi Biotechnology Co., Ltd.	5a0b4bd2-f6ad-35dc-e063-6294a90a8a66	2026-08-27	Warnings	Exact identifier unii: 15FIX9V2JP
MELAO Hydrating Lightweight Sunscreen	AVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDE	Guangdong Aimu Biological Technology Co., Ltd	59eeaea1-d726-99f3-e063-6394a90aeea3	2026-08-26	Warnings	Exact identifier unii: 15FIX9V2JP
Q Skin Science	SUNSCREEN	International Cosmeceuticals, Inc	59e4c3d0-ee4c-2350-e063-6394a90ac9d2	2026-08-25	Warnings	Exact identifier unii: 15FIX9V2JP
Electrolyte Plus	KALI MURIATICUM, L-ARGININE, L-CARNITINE, L-LEUCINE, L-ORNITHINE, L-VALINE, MAGNESIA MURIATICA, ASCORBICUM ACIDUM, BORAX, CHROMIUM OXYDATUM, FERRUM MURIATICUM, KALI CARBONICUM, MAGNESIUM GLUCONICUM DIHYDRICUM, NATRUM MURIATICUM, ZINCUM GLUCONICUM, CUPRUM METALLICUM, KALI PHOSPHORICUM, NICCOLUM METALLICUM, SELENIUM METALLICUM, VANADIUM METALLICUM, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, MANGANUM CARBONICUM	Deseret Biologicals, Inc.	e3564733-8b88-4753-9077-9d74004d8ec9	2026-08-25	Warnings	Exact identifier unii: PQ6CK8PD0R
Mirexa Mini	MIREXA MINI	Oncora Pharma, LLC	ea48f64a-9a70-40df-ba25-098353273089	2026-08-25	Warnings, Adverse reactions	Exact identifier unii: PQ6CK8PD0R
Simvastatin	SIMVASTATIN	Cardinal Health 107, LLC	b2d6c7ac-304b-4cba-974c-d9a23a069925	2026-08-25	Warnings, Adverse reactions	Exact identifier application number: ANDA078103 ndc (package): 55154-4782-0 ndc (product): 55154-4782 rxcui: 312961 spl id: 858506b9-1a8e-49a1-9d2b-d6d81e241676 spl set id: b2d6c7ac-304b-4cba-974c-d9a23a069925 unii: AGG2FN16EV
MELAO zinc stick(GREEN)	TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENE	Guangzhou Haishi Biological Technology Co., Ltd.	59c70c82-f7ff-9a04-e063-6294a90a7b3d	2026-08-24	Warnings	Exact identifier unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01	ZINC OXIDE, TITANIUM DIOXIDE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	59d74e3f-e3fa-a7a9-e063-6294a90a76e5	2026-08-24	Warnings	Exact identifier unii: 15FIX9V2JP
Rohto All-In-One	HYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATE	The Mentholatum Company	43e690e4-b381-46e3-838c-33aef5bdadde	2026-08-20	Warnings	Exact identifier unii: 3NXW29V3WO
Sweat Resistant Sunscreen Body Original	TITANIUM DIOXIDE, ZINC OXIDE	Clutch, Inc.	4bbde755-e312-123e-e063-6294a90a467f	2026-08-20	Warnings	Exact identifier unii: 15FIX9V2JP
Ascorbic Acid	ASCORBIC ACID	Renova Pharmaceuticals LLC	a6481bae-2397-44c7-a51d-4f47ad91bd2c	2026-08-19	Warnings, Adverse reactions	Exact identifier unii: PQ6CK8PD0R
Simvastatin	SIMVASTATIN	REMEDYREPACK INC.	d053fee4-b797-4a82-8865-0b4d08b14990	2026-08-19	Warnings, Adverse reactions	Exact identifier rxcui: 312961 unii: AGG2FN16EV
HEADHUNTER SURF SCREEN SPF 50 SUNSCREEN	ZINC OXIDE,TITANIUM DIOXIDE	Guangzhou Tata Biotechnology Co., Ltd.	4339df13-77d3-31a1-e063-6394a90a5208	2026-08-17	Warnings	Exact identifier unii: 15FIX9V2JP
Stay Ageless Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	HAMBLIN DERMATOLOGY	5942e64c-416e-7525-e063-6394a90a2839	2026-08-17	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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