MedPath

BACMIN

BACMIN

Approved
Approval ID

34beae32-51e4-4bdc-8ca5-1d8d79f193b2

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 2, 2014

Manufacturers
FDA

Marnel Pharmaceuticals, Inc.

DUNS: 053781795

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

VITAMIN A ACETATE, .ALPHA.-TOCOPHEROL ACETATE, ASCORBIC ACID, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, BIOTIN, CALCIUM PANTOTHENATE, FOLIC ACID, CYANOCOBALAMIN, FLAVONE, FERROUS FUMARATE, CHROMIC CHLORIDE CR-51, MAGNESIUM OXIDE, MANGANESE GLUCONATE, CUPRIC OXIDE, SELENOMETHIONINE, and ZINC OXIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0682-3001
Product Classification
G
Generic Name
VITAMIN A ACETATE, .ALPHA.-TOCOPHEROL ACETATE, ASCORBIC ACID, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, BIOTIN, CALCIUM PANTOTHENATE, FOLIC ACID, CYANOCOBALAMIN, FLAVONE, FERROUS FUMARATE, CHROMIC CHLORIDE CR-51, MAGNESIUM OXIDE, MANGANESE GLUCONATE, CUPRIC OXIDE, SELENOMETHIONINE, and ZINC OXIDE
Product Specifications
Route of AdministrationORAL
Effective DateMay 2, 2014
FDA Product Classification

INGREDIENTS (33)

VITAMIN A ACETATEActive
Quantity: 2000 [iU] in 1 1
Code: 3LE3D9D6OY
Classification: ACTIM
THIAMINE MONONITRATEActive
Quantity: 20 mg in 1 1
Code: 8K0I04919X
Classification: ACTIR
RIBOFLAVINActive
Quantity: 20 mg in 1 1
Code: TLM2976OFR
Classification: ACTIB
BIOTINActive
Quantity: 150 ug in 1 1
Code: 6SO6U10H04
Classification: ACTIB
CALCIUM PANTOTHENATEActive
Quantity: 25 mg in 1 1
Code: 568ET80C3D
Classification: ACTIM
CHROMIC CHLORIDE CR-51Active
Quantity: 0.1 mg in 1 1
Code: U4M5Y13FGM
Classification: ACTIB
CYANOCOBALAMINActive
Quantity: 50 ug in 1 1
Code: P6YC3EG204
Classification: ACTIB
MANGANESE GLUCONATEActive
Quantity: 5 mg in 1 1
Code: 9YY2F980SV
Classification: ACTIB
FLAVONEActive
Quantity: 50 mg in 1 1
Code: S2V45N7G3B
Classification: ACTIB
MAGNESIUM OXIDEActive
Quantity: 50 mg in 1 1
Code: 3A3U0GI71G
Classification: ACTIB
CUPRIC OXIDEActive
Quantity: 3 mg in 1 1
Code: V1XJQ704R4
Classification: ACTIM
stearic acidInactive
Code: 4ELV7Z65AP
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
maltodextrinInactive
Code: 7CVR7L4A2D
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
FD&C red No. 40Inactive
Code: WZB9127XOA
Classification: IACT
hypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
aluminum oxideInactive
Code: LMI26O6933
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
triacetinInactive
Code: XHX3C3X673
Classification: IACT
polyethylene glycolsInactive
Code: 3WJQ0SDW1A
Classification: IACT
hydroxypropyl cellulose (type h)Inactive
Code: RFW2ET671P
Classification: IACT
ASCORBIC ACIDActive
Quantity: 500 mg in 1 1
Code: PQ6CK8PD0R
Classification: ACTIB
NIACINAMIDEActive
Quantity: 100 mg in 1 1
Code: 25X51I8RD4
Classification: ACTIB
PYRIDOXINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: 68Y4CF58BV
Classification: ACTIM
FOLIC ACIDActive
Quantity: 1 mg in 1 1
Code: 935E97BOY8
Classification: ACTIB
FERROUS FUMARATEActive
Quantity: 27 mg in 1 1
Code: R5L488RY0Q
Classification: ACTIM
SELENOMETHIONINEActive
Quantity: 50 ug in 1 1
Code: 964MRK2PEL
Classification: ACTIB
ZINC OXIDEActive
Quantity: 22.5 mg in 1 1
Code: SOI2LOH54Z
Classification: ACTIB
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C blue No. 1Inactive
Code: H3R47K3TBD
Classification: IACT
.ALPHA.-TOCOPHEROL ACETATEActive
Quantity: 30 [iU] in 1 1
Code: 9E8X80D2L0
Classification: ACTIB

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BACMIN - FDA Drug Approval Details