GALZIN
GALZIN (Zinc Acetate) Capsules
Approved
Approval ID
a0c72bff-20f3-4241-b966-34a95178d1a3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 31, 2020
Manufacturers
FDA
Teva Pharmaceuticals USA, Inc.
DUNS: 001627975
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Zinc Acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code57844-215
Application NumberNDA020458
Product Classification
M
Marketing Category
C73594
G
Generic Name
Zinc Acetate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 16, 2023
FDA Product Classification
INGREDIENTS (12)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ZINC ACETATEActive
Quantity: 25 mg in 1 1
Code: FM5526K07A
Classification: ACTIM
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
Zinc Acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code57844-208
Application NumberNDA020458
Product Classification
M
Marketing Category
C73594
G
Generic Name
Zinc Acetate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 16, 2023
FDA Product Classification
INGREDIENTS (15)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
ZINC ACETATEActive
Quantity: 50 mg in 1 1
Code: FM5526K07A
Classification: ACTIM
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT