FDA.reportPublic FDA data

NITROGLYCERIN

Product NDC
69339-175
11-digit product format
693390175
Labeler code
69339
Product ID
69339-175_aeb4c868-1d42-4183-b86f-4ae1dc0aa6d3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NITROGLYCERIN
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
Natco Pharma USA LLC
Application
ANDA211604
Marketing category
ANDA
Marketing start
2022-10-03
Substance
NITROGLYCERIN
Active strength
.6 mg/1
Pharmacologic classes
Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
NITROGLYCERIN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NITROGLYCERIN.6 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG59M7S0WS3
Rxcui198038, 198039, 198040

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7480e90b-004b-ebe4-2243-4f2fefdd9e78Product name220260128
3f158398-73f2-4b90-47d1-5c60e8719a98Product name920250721
ca6149a6-ded3-9f17-6c41-3e88f2c0c9c0Product name220250117
00358076-c817-430b-b924-11d717dc307cProduct name120160718
669af5aa-14f3-3df7-f100-5f580ffd43c1Product name120140508
6ff3bab7-2dce-8bea-d7ce-54687f0c01fbProduct name120140508
8bb82a1c-d0d0-fc27-011f-172e545f0382Product name120140508
cb03406d-e223-80bb-67d8-be80f9b6a4f2Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69339-175-01NITROGLYCERIN1 in 1 CARTONTABLET14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69339-175NITROGLYCERIN TABLET [NATCO PHARMA USA LLC]4Current NDC, Legacy NDC, 1 package rows20230922_941ac242-120e-47c1-ac03-50026ff93dd6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198038nitroglycerin 0.3 MG Sublingual TabletPSN941ac242-120e-47c1-ac03-50026ff93dd64
198039nitroglycerin 0.4 MG Sublingual TabletPSN941ac242-120e-47c1-ac03-50026ff93dd64
198040nitroglycerin 0.6 MG Sublingual TabletPSN941ac242-120e-47c1-ac03-50026ff93dd64
198038nitroglycerin 0.3 MG Sublingual TabletSCD941ac242-120e-47c1-ac03-50026ff93dd64
198039nitroglycerin 0.4 MG Sublingual TabletSCD941ac242-120e-47c1-ac03-50026ff93dd64
198040nitroglycerin 0.6 MG Sublingual TabletSCD941ac242-120e-47c1-ac03-50026ff93dd64
198038nitroglycerin 300 MCG Sublingual TabletSY941ac242-120e-47c1-ac03-50026ff93dd64
198039nitroglycerin 400 MCG Sublingual TabletSY941ac242-120e-47c1-ac03-50026ff93dd64
198040nitroglycerin 600 MCG Sublingual TabletSY941ac242-120e-47c1-ac03-50026ff93dd64
198038NTG 0.3 MG Sublingual TabletSY941ac242-120e-47c1-ac03-50026ff93dd64
198039NTG 0.4 MG Sublingual TabletSY941ac242-120e-47c1-ac03-50026ff93dd64
198040NTG 0.6 MG Sublingual TabletSY941ac242-120e-47c1-ac03-50026ff93dd64
198038TNG 0.3 MG Sublingual TabletSY941ac242-120e-47c1-ac03-50026ff93dd64
198039TNG 0.4 MG Sublingual TabletSY941ac242-120e-47c1-ac03-50026ff93dd64
198040TNG 0.6 MG Sublingual TabletSY941ac242-120e-47c1-ac03-50026ff93dd64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69339-175-01693390175011 TABLET in 1 CARTON (69339-175-01) 1 tablet2022-10-030000-00-00NoNoCurrent