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NITROGLYCERIN

These highlights do not include all the information needed to use NITROGLYCERIN SUBLINGUAL TABLETS, USP safely and effectively. See full prescribing information for NITROGLYCERIN SUBLINGUAL TABLETS, USP NITROGLYCERIN sublingual tablets, USP, for oral use Initial U.S. Approval: 1981

Approved
Approval ID

15b04ca8-9338-4500-9cb2-7448833b4e49

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 15, 2018

Manufacturers
FDA

Sigmapharm Laboratories, LLC

DUNS: 556234636

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 Code42794-211
Application NumberANDA207745
Product Classification
M
Marketing Category
C73584
G
Generic Name
NITROGLYCERIN
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateMay 15, 2018
FDA Product Classification

INGREDIENTS (6)

LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
NITROGLYCERINActive
Quantity: 0.3 mg in 1 1
Code: G59M7S0WS3
Classification: ACTIB

NITROGLYCERIN

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code42794-212
Application NumberANDA207745
Product Classification
M
Marketing Category
C73584
G
Generic Name
NITROGLYCERIN
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateMay 15, 2018
FDA Product Classification

INGREDIENTS (6)

CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
NITROGLYCERINActive
Quantity: 0.4 mg in 1 1
Code: G59M7S0WS3
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT

NITROGLYCERIN

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code42794-213
Application NumberANDA207745
Product Classification
M
Marketing Category
C73584
G
Generic Name
NITROGLYCERIN
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateMay 15, 2018
FDA Product Classification

INGREDIENTS (6)

CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
NITROGLYCERINActive
Quantity: 0.6 mg in 1 1
Code: G59M7S0WS3
Classification: ACTIB

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NITROGLYCERIN - FDA Drug Approval Details