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 25 of 119 · 2,380 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Intellishade Matte SPF 45	OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	Revision, LLC	e213ae87-4db2-3070-e053-2995a90a083b	2026-01-13	Warnings	Exact identifier unii: 15FIX9V2JP
SIMVASTATIN	SIMVASTATIN	Lupin Pharmaceuticals, Inc.	3e48217f-8175-4e9b-9fd0-909be4bbba95	2026-01-13	Warnings, Adverse reactions	Exact identifier application number: ANDA078103 ndc (product): 68180-478 ndc (product): 68180-479 rxcui: 312962 rxcui: 312961 rxcui: 314231 rxcui: 198211 rxcui: 200345 spl id: b78d4e8a-2261-43c6-9321-ac2539bdfd2f spl set id: 3e48217f-8175-4e9b-9fd0-909be4bbba95 unii: AGG2FN16EV
Blue Lizard Sensitive SPF 50 Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	Crown Laboratories	9d20b230-2cce-4d90-e053-2995a90a4c03	2026-01-12	Warnings	Exact identifier unii: 15FIX9V2JP
Blue Lizard Sheer SPF 50 Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Crown Laboratories	c20fce25-8120-fe5d-e053-2a95a90a53a0	2026-01-12	Warnings	Exact identifier unii: 15FIX9V2JP
Blue Lizard Sheer Face SPF 50 Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	Crown Laboratories	baed8202-21fd-3a43-e053-2a95a90ada32	2026-01-12	Warnings	Exact identifier unii: 15FIX9V2JP
Blue Lizard Sensitive Face Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Crown Laboratories	88dbd396-8955-271e-e053-2995a90a0a7a	2026-01-12	Warnings	Exact identifier unii: 15FIX9V2JP
Blue Lizard Baby SPF 50 Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	Crown Laboratories	9d237fb7-4f5f-521d-e053-2a95a90a9734	2026-01-12	Warnings	Exact identifier unii: 15FIX9V2JP
Blue Lizard Sensitive Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	Crown Laboratories	1e4d49f4-9e77-48b5-bce5-ff04ed885a0f	2026-01-12	Warnings	Exact identifier unii: 15FIX9V2JP
Blue Lizard Baby SPF 50 Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	Crown Laboratories	32d6e04a-fa30-ba48-e063-6394a90a1bbf	2026-01-12	Warnings	Exact identifier unii: 15FIX9V2JP
Blue Lizard Kids SPF 50 Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	Crown Laboratories	2f780daa-4c91-5a68-e063-6394a90afd41	2026-01-12	Warnings	Exact identifier unii: 15FIX9V2JP
Blue Lizard Sport SPF 50 Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	Crown Laboratories	2f3844d8-0367-aad9-e063-6294a90a1fce	2026-01-12	Warnings	Exact identifier unii: 15FIX9V2JP
Blue Lizard Sheer Face SPF 50 Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	Crown Laboratories	30cd79da-2f25-a42a-e063-6394a90a8332	2026-01-12	Warnings	Exact identifier unii: 15FIX9V2JP
ACCOJE PROTECTIVE AIR-FIT MINERAL SUNSCREEN	TITAMIUN DIOXIDE, ZINC OXIDE	UCL Co., Ltd.	4837b4f6-ada9-801a-e063-6294a90a8547	2026-01-12	Warnings	Exact identifier unii: 15FIX9V2JP
Intellishade Original SPF 45	OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	Revision, LLC	e213a681-eb22-69c0-e053-2995a90a899e	2026-01-12	Warnings	Exact identifier unii: 15FIX9V2JP
ODLUMIVIE Tinted Mineral Sunscreen	ZINC OXIDE,TITANIUM DIOXIDE	Guangzhou Meijiao Medical Biotechnology Co., Ltd.	480d6e65-f6dc-d2a5-e063-6294a90a24a1	2026-01-10	Warnings	Exact identifier unii: 15FIX9V2JP
Sunscreen Lotion118mL	ZINC OXIDE 15%, TITANIUM DIOXIDE 6%, HOMOSALATE 5%, OCTISALATE 4%	Foshan Sugar Max Cosmetics CO.,Ltd	46355437-4068-9d03-e063-6394a90ae52c	2026-01-09	Warnings	Exact identifier unii: 15FIX9V2JP
ST MORIZ SUNCARE FACE SUNSCREEN SPF30	SUNCARE FACE SUNSCREEN SPF30	Aopline Biotechnology (Guangzhou) Co., Ltd.	47f26af6-4d02-3506-e063-6294a90a0fe6	2026-01-09	Warnings	Exact identifier unii: 15FIX9V2JP
Play Mineral Broad Spectrum SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	Supergoop, LLC	89088ac5-f1ee-1996-e053-2a95a90a8fdc	2026-01-09	Warnings	Exact identifier unii: 15FIX9V2JP
Sugargirl Set Screen SPF 30 Setting Powder Sunscreen Light	ZINC OXIDE, TITANIUM DIOXIDE	I World LLC	1fabd546-55e5-4ab2-8a1b-7b161bfbb866	2026-01-09	Warnings	Exact identifier unii: 15FIX9V2JP
Sugargirl Set Screen SPF 30 Setting Sunscreen Medium	ZINC OXIDE, TITANIUM DIOXIDE	I World LLC	876a6f88-8dac-4303-8acb-525999c93528	2026-01-09	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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