NEONATAL19
NEONATAL 19
Approved
Approval ID
8c3737b7-7795-4eca-9684-8ec755a8b594
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 24, 2020
Manufacturers
FDA
SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS
DUNS: 081225162
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ascorbic acid, thiamine, riboflavin, niacinamide, pyridoxine, folic acid, cyanocobalamin, biotin, pantothenic acid
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code73317-8242
Product Classification
G
Generic Name
ascorbic acid, thiamine, riboflavin, niacinamide, pyridoxine, folic acid, cyanocobalamin, biotin, pantothenic acid
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 25, 2020
FDA Product Classification
INGREDIENTS (16)
THIAMINE MONONITRATEActive
Quantity: 1.5 mg in 1 1
Code: 8K0I04919X
Classification: ACTIR
RIBOFLAVINActive
Quantity: 1.7 mg in 1 1
Code: TLM2976OFR
Classification: ACTIB
CYANOCOBALAMINActive
Quantity: 6 ug in 1 1
Code: P6YC3EG204
Classification: ACTIB
BIOTINActive
Quantity: 150 ug in 1 1
Code: 6SO6U10H04
Classification: ACTIB
CALCIUM PANTOTHENATEActive
Quantity: 5 mg in 1 1
Code: 568ET80C3D
Classification: ACTIM
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: L11K75P92J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
ASCORBIC ACIDActive
Quantity: 100 mg in 1 1
Code: PQ6CK8PD0R
Classification: ACTIB
NIACINAMIDEActive
Quantity: 20 mg in 1 1
Code: 25X51I8RD4
Classification: ACTIB
PYRIDOXINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 68Y4CF58BV
Classification: ACTIB
FOLIC ACIDActive
Quantity: 1000 ug in 1 1
Code: 935E97BOY8
Classification: ACTIB
OPADRY YS-1-12726A YELLOWInactive
Code: PLG7GLN7QI
Classification: IACT