NDC 68084-511-11 - 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: 68084-511
Requested NDC: 68084-511-11
Package NDCs from labels: 68084-511-11, 68084-511-01
Manufacturer: American Health Packaging
Effective date: 2025-08-25
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Simvastatin - 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
68084-511-01	Simvastatin	100 in 1 BOX, UNIT-DOSE	TABLET, FILM COATED	100		13
68084-511-11	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
68084-511	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
68084-511-01	EA - Each	68084-511	edef15c4-69c3-4ff2-b915-52dfc99d2f36	1	2012-07-24
68084-511-11	EA - Each	68084-511	d975f866-e6b3-4324-9d0f-20b6287920b5	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
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 28 of 119 · 2,380 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 110 ALABASTER	OCTINOXATE AND TITANIUM DIOXIDE	SHISEIDO AMERICAS CORPORATION	0a214b6b-69a7-4cb9-9095-6fcf2b6945de	2026-01-05	Warnings	Exact identifier unii: 15FIX9V2JP
SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 430 CEDAR	OCTINOXATE AND TITANIUM DIOXIDE	SHISEIDO AMERICAS CORPORATION	fb6ac681-ff74-4420-a4f6-843d5f2b6d6b	2026-01-05	Warnings	Exact identifier unii: 15FIX9V2JP
Hawaiian Blend Essential Zinc SPF 50	ZINC OXIDE, TITANIUM DIOXIDE	The Islander Group	47aa8605-e536-b998-e063-6394a90ad9f0	2026-01-05	Warnings	Exact identifier unii: 15FIX9V2JP
SHISEIDO WHITE LUCENT ONMAKEUP SPOT CORRECTING SERUM NATURAL LIGHT	OCTINOXATE AND TITANIUM DIOXIDE	SHISEIDO AMERICAS CORPORATION	bf736c5b-fc33-4cd5-8d18-03929f739d76	2026-01-05	Warnings	Exact identifier unii: 15FIX9V2JP
CLE DE PEAU BEAUTE RADIANT CORRECTOR FOR EYES IVORY	OCTINOXATE AND TITANIUM DIOXIDE	SHISEIDO AMERICAS CORPORATION	c4028089-677f-4d51-9c8b-3892ff1649e0	2026-01-05	Warnings	Exact identifier unii: 15FIX9V2JP
SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 110	OCTINOXATE AND TITANIUM DIOXIDE	SHISEIDO AMERICAS CORPORATION	8a0da327-a805-4ef9-b69a-14bf7278a81a	2026-01-05	Warnings	Exact identifier unii: 15FIX9V2JP
CLE DE PEAU BEAUTE CORRECTING VEIL n	ENSULIZOLE, OCTINOXATE, AND TITANIUM DIOXIDE	SHISEIDO AMERICAS CORPORATION	fd9b42e4-6f9d-45a9-bee3-ac1bc4b35252	2026-01-05	Warnings	Exact identifier unii: 15FIX9V2JP
SHISEIDO THE MAKEUP FOUNDATION I20	TITANIUM DIOXIDE	SHISEIDO AMERICAS CORPORATION	3c024fe9-2983-4857-a55a-13406158e3a9	2026-01-05	Warnings	Exact identifier unii: 15FIX9V2JP
cle de peau BEAUTE RADIANT FLUID FOUNDATION BF10	TITANIUM DIOXIDE	SHISEIDO AMERICAS CORPORATION	b2b55a7a-1f68-429d-ba70-5bb6c7e0d8d3	2026-01-05	Warnings	Exact identifier unii: 15FIX9V2JP
TRICK AND TREAT CC2 - Active Moisturizing Color Correcting Broad-Spectrum SPF 46 Plus	TITANIUM DIOXIDE	HEY HONEY INC.	21187805-fae9-476c-81b0-27ffeb0b9911	2026-01-05	Warnings	Exact identifier unii: 15FIX9V2JP
Bellas Friends Roll-on Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	PANERGYTEK USA INC	478d46ce-14e8-2231-e063-6394a90a3e27	2026-01-04	Warnings	Exact identifier unii: 15FIX9V2JP
simvastatin	SIMVASTATIN	Northwind Health Company, LLC	db0f4c5a-e8e4-3ab1-e053-2995a90a1f9a	2026-01-01	Warnings, Adverse reactions	Exact identifier rxcui: 314231 unii: AGG2FN16EV
simvastatin	SIMVASTATIN	Northwind Health Company, LLC	f32d512f-86fa-b70f-e053-2a95a90afd01	2026-01-01	Warnings, Adverse reactions	Exact identifier rxcui: 198211 unii: AGG2FN16EV
Simvastatin	SIMVASTATIN	Northwind Health Company, LLC	f7567996-4e81-7c12-e053-6394a90aa087	2026-01-01	Warnings, Adverse reactions	Exact identifier rxcui: 198211 unii: AGG2FN16EV
SIMVASTATIN	SIMVASTATIN	Northwind Health Company, LLC	f835af8f-7d84-1978-e053-6294a90a22ae	2026-01-01	Warnings, Adverse reactions	Exact identifier application number: ANDA078103 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 application number: ANDA078103 rxcui: 312961 unii: AGG2FN16EV
SIMVASTATIN	SIMVASTATIN	Proficient Rx LP	8e686832-1caf-425c-9ca6-7eaade43b6fe	2026-01-01	Warnings, Adverse reactions	Exact identifier application number: ANDA078103 rxcui: 312961 unii: AGG2FN16EV
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

Reported adverse events (FAERS/openFDA)#

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