FDA.reportPublic FDA data

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
LabelManufacturerEffective dateType
Simvastatin - American Health PackagingAmerican Health Packaging2025-08-25HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68084-511-01Simvastatin100 in 1 BOX, UNIT-DOSETABLET, FILM COATED10013
68084-511-11Simvastatin1 in 1 BLISTER PACKTABLET, FILM COATED113

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-511SIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]12Current NDC, Legacy NDC, 2 package rows20241010_4bec3923-6221-4b8b-9a72-872a63680de1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-511-01EA - Each68084-511edef15c4-69c3-4ff2-b915-52dfc99d2f3612012-07-24
68084-511-11EA - Each68084-511d975f866-e6b3-4324-9d0f-20b6287920b512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SIMVASTATINACTIVE INGREDIENTAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
SIMVASTATINACTIVE MOIETYAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RSIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2USIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357SIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PSIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
TALCINACTIVE INGREDIENT7SEV7J4R1USIMVASTATIN TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSIMVASTATIN 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 32 of 119 · 2,380 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TiZO3TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.468d6476-127a-e9f0-e063-6294a90a3df92025-12-22WarningsExact identifier
unii: 15FIX9V2JP
YOUR SKIN BUT BETTER FAIRTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLC3e65ec1a-0ed9-433d-8da9-a6cb618299112025-12-22WarningsExact identifier
unii: 15FIX9V2JP
THE MELT MIST Sheerest Mineral Mist Suncare for BodyTITANIUM DIOXIDE, ZINC OXIDEDune Suncare, Inc.465d3277-7798-512a-e063-6294a90a20652025-12-20WarningsExact identifier
unii: 15FIX9V2JP
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 9NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior7287078e-67ff-41fe-bc8d-59b2146f5dc92025-12-19WarningsExact identifier
unii: 15FIX9V2JP
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 2WOOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb6095639-e2ee-418e-b4f1-e59da1bd92162025-12-19WarningsExact identifier
unii: 15FIX9V2JP
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 2NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior8c6466a6-4f11-4210-bb02-eb31c15984cd2025-12-19WarningsExact identifier
unii: 15FIX9V2JP
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 2WOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior07f8282b-047b-4be1-8779-39ed5dd6fb5d2025-12-19WarningsExact identifier
unii: 15FIX9V2JP
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 2CROCTISALATE, TITANIUM DIOXIDEParfums Christian Dior5a8c67c1-aeba-490d-8347-a30916efcf3b2025-12-19WarningsExact identifier
unii: 15FIX9V2JP
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 1WOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior739450b0-8cd7-41de-8cd0-1827e02478c62025-12-19WarningsExact identifier
unii: 15FIX9V2JP
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 1.5NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior08b0e056-583a-474b-aaaa-ecea057030442025-12-19WarningsExact identifier
unii: 15FIX9V2JP
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 2.5WOCTISALATE, TITANIUM DIOXIDEParfums Christian Diora89af40e-cf45-4afc-aac7-5f71a05bcd3f2025-12-19WarningsExact identifier
unii: 15FIX9V2JP
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 2.5NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior6da72e20-f2d7-492e-9b65-b5ac73bc00292025-12-19WarningsExact identifier
unii: 15FIX9V2JP
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 1CROCTISALATE, TITANIUM DIOXIDEParfums Christian Diorde615c3e-669f-493c-9c75-73dfbe726c592025-12-19WarningsExact identifier
unii: 15FIX9V2JP
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 1NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior152790ba-aeda-4c2a-b725-7e040e8328832025-12-19WarningsExact identifier
unii: 15FIX9V2JP
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 1.5WOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior5f5cd18a-04fa-4b53-b7e9-6b1e97acc61a2025-12-19WarningsExact identifier
unii: 15FIX9V2JP
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 0WOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior54f7fe8d-aab4-4fab-b239-52c5e7ce7c0c2025-12-19WarningsExact identifier
unii: 15FIX9V2JP
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 0NOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorc87e5201-f7fd-4fd9-adeb-d6af9be00db62025-12-19WarningsExact identifier
unii: 15FIX9V2JP
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 0CROCTISALATE, TITANIUM DIOXIDEParfums Christian Dior84cdaad2-5b7d-4841-bef6-ffad4fe6907a2025-12-19WarningsExact identifier
unii: 15FIX9V2JP
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 00OCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb4caa2bc-8118-4137-8834-25800f8e5e012025-12-19WarningsExact identifier
unii: 15FIX9V2JP
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 0.5NOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorc0fa32fe-faa7-4a47-906c-14db01e55d472025-12-19WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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