Nitroglycerin
Nitroglycerin Sublingual Tablets USP
Approved
Approval ID
c555f8de-477f-0225-98a2-baf8945bbd63
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 10, 2017
Manufacturers
FDA
Dr. Reddys Laboratories Inc
DUNS: 802315887
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Nitroglycerin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43598-435
Application NumberANDA208191
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nitroglycerin
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateFebruary 10, 2017
FDA Product Classification
INGREDIENTS (6)
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
NITROGLYCERINActive
Quantity: 0.3 mg in 1 1
Code: G59M7S0WS3
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
Hydrogenated Cottonseed OilInactive
Code: Z82Y2C65EA
Classification: IACT
Nitroglycerin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43598-436
Application NumberANDA208191
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nitroglycerin
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateFebruary 10, 2017
FDA Product Classification
INGREDIENTS (6)
Hydrogenated Cottonseed OilInactive
Code: Z82Y2C65EA
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
NITROGLYCERINActive
Quantity: 0.4 mg in 1 1
Code: G59M7S0WS3
Classification: ACTIB
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
Nitroglycerin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43598-437
Application NumberANDA208191
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nitroglycerin
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateFebruary 10, 2017
FDA Product Classification
INGREDIENTS (6)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
NITROGLYCERINActive
Quantity: 0.6 mg in 1 1
Code: G59M7S0WS3
Classification: ACTIB
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
Hydrogenated Cottonseed OilInactive
Code: Z82Y2C65EA
Classification: IACT