FDA.reportPublic FDA data

NITROGLYCERIN

Product NDC
85766-116
11-digit product format
857660116
Labeler code
85766
Product ID
85766-116_50321bf1-3be4-6a2b-e063-6394a90aa218
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NITROGLYCERIN
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
Sportpharm LLC
Application
ANDA211604
Marketing category
ANDA
Marketing start
2022-10-03
Substance
NITROGLYCERIN
Active strength
.4 mg/1
Pharmacologic classes
Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
NITROGLYCERIN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NITROGLYCERIN.4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG59M7S0WS3
Rxcui198039

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
85766-116-00NITROGLYCERIN25 in 1 BOTTLETABLET252
85766-116-00NITROGLYCERIN4 in 1 CARTONTABLET42
85766-116-01NITROGLYCERIN1 in 1 CARTONTABLET12
85766-116-01NITROGLYCERIN100 in 1 BOTTLETABLET1002
85766-116-10NITROGLYCERIN10 in 1 BOTTLETABLET102
85766-116-20NITROGLYCERIN20 in 1 BOTTLETABLET202
85766-116-25NITROGLYCERIN25 in 1 BOTTLETABLET252
85766-116-30NITROGLYCERIN30 in 1 BOTTLETABLET302
85766-116-60NITROGLYCERIN60 in 1 BOTTLETABLET602
85766-116-90NITROGLYCERIN90 in 1 BOTTLETABLET902

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198039nitroglycerin 0.4 MG Sublingual TabletPSN84739085-81df-4a43-8456-c9edfbf971e92
198039nitroglycerin 0.4 MG Sublingual TabletSCD84739085-81df-4a43-8456-c9edfbf971e92
198039nitroglycerin 400 MCG Sublingual TabletSY84739085-81df-4a43-8456-c9edfbf971e92
198039NTG 0.4 MG Sublingual TabletSY84739085-81df-4a43-8456-c9edfbf971e92
198039TNG 0.4 MG Sublingual TabletSY84739085-81df-4a43-8456-c9edfbf971e92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85766-116-00857660116004 BOTTLE in 1 CARTON (85766-116-00) / 25 TABLET in 1 BOTTLE4 bottle2025-10-31NoNoHistorical
85766-116-01857660116011 BOTTLE in 1 CARTON (85766-116-01) / 100 TABLET in 1 BOTTLE1 bottle2025-10-31NoNoHistorical
85766-116-108576601161010 TABLET in 1 BOTTLE (85766-116-10) 10 tablet2025-10-31NoNoHistorical
85766-116-208576601162020 TABLET in 1 BOTTLE (85766-116-20) 20 tablet2025-10-31NoNoHistorical
85766-116-258576601162525 TABLET in 1 BOTTLE (85766-116-25) 25 tablet2025-10-31NoNoHistorical
85766-116-308576601163030 TABLET in 1 BOTTLE (85766-116-30) 30 tablet2025-10-31NoNoHistorical
85766-116-608576601166060 TABLET in 1 BOTTLE (85766-116-60) 60 tablet2025-10-31NoNoHistorical
85766-116-908576601169090 TABLET in 1 BOTTLE (85766-116-90) 90 tablet2025-10-31NoNoHistorical