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FDA Approval

BACMIN

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Marnel Pharmaceuticals, Inc.
DUNS: 053781795
Effective Date
May 2, 2014
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Vitamin A acetate(2000 [iU] in 1 1)
Thiamine(20 mg in 1 1)
Riboflavin(20 mg in 1 1)
Biotin(150 ug in 1 1)
Pantothenic acid(25 mg in 1 1)
Chromic citrate(0.1 mg in 1 1)
Vitamin B12(50 ug in 1 1)
Manganese gluconate(5 mg in 1 1)
Flavone(50 mg in 1 1)
Magnesium oxide(50 mg in 1 1)
Cupric oxide(3 mg in 1 1)
Vitamin C(500 mg in 1 1)
Nicotinamide(100 mg in 1 1)
Pyridoxine(25 mg in 1 1)
Folic acid(1 mg in 1 1)
Ferrous fumarate(27 mg in 1 1)
Selenomethionine(50 ug in 1 1)
Zinc oxide(22.5 mg in 1 1)
alpha-Tocopherol acetate(30 [iU] in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Nexgen Pharma, Inc.

Marnel Pharmaceuticals, Inc.

160356114

Products1

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

BACMIN

Product Details

NDC Product Code
0682-3001
Route of Administration
ORAL
Effective Date
May 2, 2014
Code: 3LE3D9D6OYClass: ACTIMQuantity: 2000 [iU] in 1 1
ThiamineActive
Code: 8K0I04919XClass: ACTIRQuantity: 20 mg in 1 1
Code: TLM2976OFRClass: ACTIBQuantity: 20 mg in 1 1
BiotinActive
Code: 6SO6U10H04Class: ACTIBQuantity: 150 ug in 1 1
Code: 568ET80C3DClass: ACTIMQuantity: 25 mg in 1 1
Code: U4M5Y13FGMClass: ACTIBQuantity: 0.1 mg in 1 1
Code: P6YC3EG204Class: ACTIBQuantity: 50 ug in 1 1
Code: 9YY2F980SVClass: ACTIBQuantity: 5 mg in 1 1
FlavoneActive
Code: S2V45N7G3BClass: ACTIBQuantity: 50 mg in 1 1
Code: 3A3U0GI71GClass: ACTIBQuantity: 50 mg in 1 1
Code: V1XJQ704R4Class: ACTIMQuantity: 3 mg in 1 1
stearic acidInactive
Code: 4ELV7Z65APClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
maltodextrinInactive
Code: 7CVR7L4A2DClass: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48Class: IACT
FD&C red No. 40Inactive
Code: WZB9127XOAClass: IACT
hypromellosesInactive
Code: 3NXW29V3WOClass: IACT
aluminum oxideInactive
Code: LMI26O6933Class: IACT
titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
triacetinInactive
Code: XHX3C3X673Class: IACT
polyethylene glycolsInactive
Code: 3WJQ0SDW1AClass: IACT
hydroxypropyl cellulose (type h)Inactive
Code: RFW2ET671PClass: IACT
Vitamin CActive
Code: PQ6CK8PD0RClass: ACTIBQuantity: 500 mg in 1 1
Code: 25X51I8RD4Class: ACTIBQuantity: 100 mg in 1 1
Code: 68Y4CF58BVClass: ACTIMQuantity: 25 mg in 1 1
Code: 935E97BOY8Class: ACTIBQuantity: 1 mg in 1 1
Code: R5L488RY0QClass: ACTIMQuantity: 27 mg in 1 1
Code: 964MRK2PELClass: ACTIBQuantity: 50 ug in 1 1
Code: SOI2LOH54ZClass: ACTIBQuantity: 22.5 mg in 1 1
cellulose, microcrystallineInactive
Code: OP1R32D61UClass: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4Class: IACT
FD&C blue No. 1Inactive
Code: H3R47K3TBDClass: IACT
Code: 9E8X80D2L0Class: ACTIBQuantity: 30 [iU] in 1 1
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