MedPath

Nitroglycerin Slocaps

Nitroglycerin Slocaps Nitroglycerin Sustained-release Capsules 2.5 mg, 6.5 mg, 9 mg

Approved
Approval ID

bd2f4e87-e595-4099-acb9-e36803170f72

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 3, 2011

Manufacturers
FDA

Rebel Distributors Corp

DUNS: 118802834

Products 2

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

Nitroglycerin Sustained-release capsules

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code21695-635
Product Classification
G
Generic Name
Nitroglycerin Sustained-release capsules
Product Specifications
Route of AdministrationORAL
Effective DateOctober 13, 2009
FDA Product Classification

INGREDIENTS (9)

GELATINInactive
Code: 2G86QN327L
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
NITROGLYCERINActive
Quantity: 2.5 mg in 1 1
Code: G59M7S0WS3
Classification: ACTIB

Nitroglycerin Sustained-release capsules

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code21695-636
Product Classification
G
Generic Name
Nitroglycerin Sustained-release capsules
Product Specifications
Route of AdministrationORAL
Effective DateOctober 13, 2009
FDA Product Classification

INGREDIENTS (10)

LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
D&C RED NO. 33Inactive
Code: 9DBA0SBB0L
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
NITROGLYCERINActive
Quantity: 6.5 mg in 1 1
Code: G59M7S0WS3
Classification: ACTIB
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Nitroglycerin Slocaps - FDA Drug Approval Details