BP Vit 3

Product NDC
42192-301
11-digit product format
421920301
Labeler code
42192
Product ID
42192-301_0c3ef3d6-cd24-4253-a3eb-4d06e3047bf7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
folic acid, pyridoxine hydrochloride, cyanocobalamin, omega-3 fatty acids, doconexent, icosapent and .beta.-sitosterol
Dosage form
CAPSULE, COATED
Route
ORAL
Labeler
Acella Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2009-04-17
Substance
.BETA.-SITOSTEROL; CYANOCOBALAMIN; DOCONEXENT; FOLIC ACID; ICOSAPENT; OMEGA-3 FATTY ACIDS; PYRIDOXINE HYDROCHLORIDE
Active strength
200; 500; 350; 1; 35; 500; 12.5 mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1
Pharmacologic classes
Analogs/Derivatives [Chemical/Ingredient], Fatty Acids, Omega-3 [CS], Omega-3 Fatty Acid [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
BP Vit 3
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
.BETA.-SITOSTEROL200 mg/1
CYANOCOBALAMIN500 ug/1
DOCONEXENT350 mg/1
FOLIC ACID1 mg/1
ICOSAPENT35 mg/1
OMEGA-3 FATTY ACIDS500 mg/1
PYRIDOXINE HYDROCHLORIDE12.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiS347WMO6M4, P6YC3EG204, ZAD9OKH9JC, 935E97BOY8, AAN7QOV9EA, 71M78END5S, 68Y4CF58BV

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f6766515-27b8-72de-2010-167151236aceProduct name720251021
ef9a935e-31b7-402c-a66c-716cdfe4f126Product name920241218
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
115c5bd2-98e1-4a98-8292-90803ca7e851Product name120220127
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42192-301-602025-02-13C16284748780-12cef2736-98fd-d83d-e063-dadaa90ab31fBP Vit 3 Capsules Rx Only
42192-301-602025-01-30C16284748780-12cef2736-98fd-d83d-e063-dadaa90ab31fBP Vit 3 Capsules Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42192-301-60BP Vit 360 in 1 BOTTLECAPSULE, COATED606

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42192-301-60EA - Each42192-301ef12a497-883d-42de-82b2-cb4448445dfb12014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
.BETA.-SITOSTEROLACTIVE INGREDIENTS347WMO6M4BP VIT 3 ( FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, OMEGA-3 FATTY ACIDS, DOCONEXENT, ICOSAPENT AND .BETA.-SITOSTEROL) CAPSULE, COATED [ACELLA PHARMACEUTICALS, LLC]1
CYANOCOBALAMINACTIVE INGREDIENTP6YC3EG204BP VIT 3 ( FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, OMEGA-3 FATTY ACIDS, DOCONEXENT, ICOSAPENT AND .BETA.-SITOSTEROL) CAPSULE, COATED [ACELLA PHARMACEUTICALS, LLC]1
DOCONEXENTACTIVE INGREDIENTZAD9OKH9JCBP VIT 3 ( FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, OMEGA-3 FATTY ACIDS, DOCONEXENT, ICOSAPENT AND .BETA.-SITOSTEROL) CAPSULE, COATED [ACELLA PHARMACEUTICALS, LLC]1
FOLIC ACIDACTIVE INGREDIENT935E97BOY8BP VIT 3 ( FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, OMEGA-3 FATTY ACIDS, DOCONEXENT, ICOSAPENT AND .BETA.-SITOSTEROL) CAPSULE, COATED [ACELLA PHARMACEUTICALS, LLC]1
ICOSAPENTACTIVE INGREDIENTAAN7QOV9EABP VIT 3 ( FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, OMEGA-3 FATTY ACIDS, DOCONEXENT, ICOSAPENT AND .BETA.-SITOSTEROL) CAPSULE, COATED [ACELLA PHARMACEUTICALS, LLC]1
OMEGA-3 FATTY ACIDSACTIVE INGREDIENT71M78END5SBP VIT 3 ( FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, OMEGA-3 FATTY ACIDS, DOCONEXENT, ICOSAPENT AND .BETA.-SITOSTEROL) CAPSULE, COATED [ACELLA PHARMACEUTICALS, LLC]1
PYRIDOXINE HYDROCHLORIDEACTIVE INGREDIENT68Y4CF58BVBP VIT 3 ( FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, OMEGA-3 FATTY ACIDS, DOCONEXENT, ICOSAPENT AND .BETA.-SITOSTEROL) CAPSULE, COATED [ACELLA PHARMACEUTICALS, LLC]1
.BETA.-SITOSTEROLACTIVE MOIETYS347WMO6M4BP VIT 3 ( FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, OMEGA-3 FATTY ACIDS, DOCONEXENT, ICOSAPENT AND .BETA.-SITOSTEROL) CAPSULE, COATED [ACELLA PHARMACEUTICALS, LLC]1
CYANOCOBALAMINACTIVE MOIETYP6YC3EG204BP VIT 3 ( FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, OMEGA-3 FATTY ACIDS, DOCONEXENT, ICOSAPENT AND .BETA.-SITOSTEROL) CAPSULE, COATED [ACELLA PHARMACEUTICALS, LLC]1
DOCONEXENTACTIVE MOIETYZAD9OKH9JCBP VIT 3 ( FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, OMEGA-3 FATTY ACIDS, DOCONEXENT, ICOSAPENT AND .BETA.-SITOSTEROL) CAPSULE, COATED [ACELLA PHARMACEUTICALS, LLC]1
FOLIC ACIDACTIVE MOIETY935E97BOY8BP VIT 3 ( FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, OMEGA-3 FATTY ACIDS, DOCONEXENT, ICOSAPENT AND .BETA.-SITOSTEROL) CAPSULE, COATED [ACELLA PHARMACEUTICALS, LLC]1
ICOSAPENTACTIVE MOIETYAAN7QOV9EABP VIT 3 ( FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, OMEGA-3 FATTY ACIDS, DOCONEXENT, ICOSAPENT AND .BETA.-SITOSTEROL) CAPSULE, COATED [ACELLA PHARMACEUTICALS, LLC]1
OMEGA-3 FATTY ACIDSACTIVE MOIETY71M78END5SBP VIT 3 ( FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, OMEGA-3 FATTY ACIDS, DOCONEXENT, ICOSAPENT AND .BETA.-SITOSTEROL) CAPSULE, COATED [ACELLA PHARMACEUTICALS, LLC]1
PYRIDOXINEACTIVE MOIETYKV2JZ1BI6ZBP VIT 3 ( FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, OMEGA-3 FATTY ACIDS, DOCONEXENT, ICOSAPENT AND .BETA.-SITOSTEROL) CAPSULE, COATED [ACELLA PHARMACEUTICALS, LLC]1
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RBP VIT 3 ( FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, OMEGA-3 FATTY ACIDS, DOCONEXENT, ICOSAPENT AND .BETA.-SITOSTEROL) CAPSULE, COATED [ACELLA PHARMACEUTICALS, LLC]1
ASCORBYL PALMITATEINACTIVE INGREDIENTQN83US2B0NBP VIT 3 ( FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, OMEGA-3 FATTY ACIDS, DOCONEXENT, ICOSAPENT AND .BETA.-SITOSTEROL) CAPSULE, COATED [ACELLA PHARMACEUTICALS, LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOABP VIT 3 ( FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, OMEGA-3 FATTY ACIDS, DOCONEXENT, ICOSAPENT AND .BETA.-SITOSTEROL) CAPSULE, COATED [ACELLA PHARMACEUTICALS, LLC]1
GELATININACTIVE INGREDIENT2G86QN327LBP VIT 3 ( FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, OMEGA-3 FATTY ACIDS, DOCONEXENT, ICOSAPENT AND .BETA.-SITOSTEROL) CAPSULE, COATED [ACELLA PHARMACEUTICALS, LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBP VIT 3 ( FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, OMEGA-3 FATTY ACIDS, DOCONEXENT, ICOSAPENT AND .BETA.-SITOSTEROL) CAPSULE, COATED [ACELLA PHARMACEUTICALS, LLC]1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62BP VIT 3 ( FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, OMEGA-3 FATTY ACIDS, DOCONEXENT, ICOSAPENT AND .BETA.-SITOSTEROL) CAPSULE, COATED [ACELLA PHARMACEUTICALS, LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBP VIT 3 ( FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, OMEGA-3 FATTY ACIDS, DOCONEXENT, ICOSAPENT AND .BETA.-SITOSTEROL) CAPSULE, COATED [ACELLA PHARMACEUTICALS, LLC]1
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P8BP VIT 3 ( FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, OMEGA-3 FATTY ACIDS, DOCONEXENT, ICOSAPENT AND .BETA.-SITOSTEROL) CAPSULE, COATED [ACELLA PHARMACEUTICALS, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RBP VIT 3 ( FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, OMEGA-3 FATTY ACIDS, DOCONEXENT, ICOSAPENT AND .BETA.-SITOSTEROL) CAPSULE, COATED [ACELLA PHARMACEUTICALS, LLC]1
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FBP VIT 3 ( FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, OMEGA-3 FATTY ACIDS, DOCONEXENT, ICOSAPENT AND .BETA.-SITOSTEROL) CAPSULE, COATED [ACELLA PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42192-301BP VIT 3 ( FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, OMEGA-3 FATTY ACIDS, DOCONEXENT, ICOSAPENT AND .BETA.-SITOSTEROL) CAPSULE, COATED [ACELLA PHARMACEUTICALS, LLC]6Current NDC, 1 package rows20250215_8bf7a233-1813-4989-8886-fe7257a16054.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
42192-301-604219203016060 CAPSULE, COATED in 1 BOTTLE (42192-301-60) 2009-04-17NoNoCurrent