FDA.reportPublic FDA data

NDC 63629-3385-01 - 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
63629-3385
Requested NDC
63629-3385-01
Package NDCs from labels
63629-3385-1, 63629-3385-2, 63629-3385-3, 63629-3385-4, 63629-3385-5, 63629-3385-6, 63629-3385-7, 63629-3385-8, 63629-3385-01
Manufacturer
Bryant Ranch Prepack
Effective date
2024-08-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
simvastatin - Bryant Ranch PrepackBryant Ranch Prepack2024-08-08HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-3385-1simvastatin30 in 1 BOTTLETABLET, FILM COATED301019
63629-3385-2simvastatin60 in 1 BOTTLETABLET, FILM COATED601019
63629-3385-3simvastatin90 in 1 BOTTLETABLET, FILM COATED901019
63629-3385-4simvastatin180 in 1 BOTTLETABLET, FILM COATED1801019
63629-3385-5simvastatin100 in 1 BOTTLETABLET, FILM COATED1001019
63629-3385-6simvastatin120 in 1 BOTTLETABLET, FILM COATED1201019
63629-3385-7simvastatin28 in 1 BOTTLETABLET, FILM COATED281019
63629-3385-8simvastatin10 in 1 BOTTLETABLET, FILM COATED101019

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-3385SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1019Current NDC, Legacy NDC, 8 package rows20240820_356ed6a6-e467-4791-87ff-2ae7779fc1b0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-3385-1EA - Each63629-3385e474f10c-b670-4fed-9d25-4f877a4f23ef12013-02-13
63629-3385-2EA - Each63629-3385b161cbf5-6831-4c0d-8daf-c5220d8e093312013-02-13
63629-3385-3EA - Each63629-3385ed87111d-f800-4957-b064-47618869319212013-02-13
63629-3385-4EA - Each63629-33854228277e-4348-4fbb-9b33-e6695d8aafd512013-02-13
63629-3385-5EA - Each63629-33856310f555-ce42-42ea-af73-587c418d3f3f12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SIMVASTATINACTIVE INGREDIENTAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
SIMVASTATINACTIVE MOIETYAGG2FN16EVSIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RSIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2USIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PSIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
TALCINACTIVE INGREDIENT7SEV7J4R1USIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMSIMVASTATIN TABLET, FILM COATED [BRYANT RANCH PREPACK]1000

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 9 of 122 · 2,437 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 4W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior7a2bd17d-0ea7-4326-9939-a747869c01d22026-05-06WarningsExact identifier
unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 4N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diora396c0eb-f91f-4732-9c20-6b25aa0634b72026-05-06WarningsExact identifier
unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 6N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior18b21fba-f6ee-4ac5-a536-096716f51da02026-05-06WarningsExact identifier
unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 1N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior13c34bba-f939-4aa7-9457-9d6025902e062026-05-06WarningsExact identifier
unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 3CR Cool RosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Diord12905b6-97aa-429a-8800-23856fe31f062026-05-06WarningsExact identifier
unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 0N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior43599d17-81f4-4c6e-b6bd-d1e700b668ee2026-05-06WarningsExact identifier
unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 0.5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior116f09db-f859-40c5-8857-33503903ee762026-05-06WarningsExact identifier
unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 2N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior480e5bf9-8e24-4335-a434-93255ceb640e2026-05-06WarningsExact identifier
unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 1.5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior7057feab-20fe-4547-8223-0816904bcfd62026-05-06WarningsExact identifier
unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 1CR Cool RosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior672a804d-ba8e-4c03-91fc-3edc0b12c6272026-05-06WarningsExact identifier
unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 3.5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb656394d-a410-4f8c-a632-815a349fb17e2026-05-06WarningsExact identifier
unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 6.5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior4d47292f-35f2-4e9f-a9d8-2df57cbe92cf2026-05-06WarningsExact identifier
unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 7N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior96258152-5255-4f04-9a35-c5a76b9c05202026-05-06WarningsExact identifier
unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 3W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior5df158da-3280-4ce6-a04c-3709993434002026-05-06WarningsExact identifier
unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 2.5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorbe60feb0-8c16-4ef6-a36f-423ed18e098c2026-05-06WarningsExact identifier
unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 3N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior2d7678b4-b082-4911-80a2-c019eb5294142026-05-06WarningsExact identifier
unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 9N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior00c9da7c-d4c7-49da-afa9-1fde93a815402026-05-06WarningsExact identifier
unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 2W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior201acd8e-23c6-43fd-81dc-a814c3d8160b2026-05-06WarningsExact identifier
unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 8N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb24806b1-d9da-4373-b072-6d9a262ea3652026-05-06WarningsExact identifier
unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorc981ae5e-e7e8-484b-b682-fb96d501e03b2026-05-06WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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