FDA.reportPublic FDA data

Nitroglycerin

Product NDC
72888-140
11-digit product format
728880140
Labeler code
72888
Product ID
72888-140_47c90f3e-a3c2-7435-e063-6294a90a31a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nitroglycerin
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
Advagen Pharma Ltd
Application
ANDA209779
Marketing category
ANDA
Marketing start
2021-05-03
Substance
NITROGLYCERIN
Active strength
.6 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.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
72888-140-01Nitroglycerin100 in 1 BOTTLETABLET1003
72888-140-01Nitroglycerin1 in 1 CARTONTABLET13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72888-140-01EA - Each72888-140ca222983-ea85-478a-b3bc-b1a3fc04f28312023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72888-140NITROGLYCERIN TABLET [ADVAGEN PHARMA LTD]2Current NDC, 2 package rows20230928_5a36dac2-7d35-4cbf-be3d-705b7135754d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198038nitroglycerin 0.3 MG Sublingual TabletPSN5a36dac2-7d35-4cbf-be3d-705b7135754d3
198039nitroglycerin 0.4 MG Sublingual TabletPSN5a36dac2-7d35-4cbf-be3d-705b7135754d3
198040nitroglycerin 0.6 MG Sublingual TabletPSN5a36dac2-7d35-4cbf-be3d-705b7135754d3
198038nitroglycerin 0.3 MG Sublingual TabletSCD5a36dac2-7d35-4cbf-be3d-705b7135754d3
198039nitroglycerin 0.4 MG Sublingual TabletSCD5a36dac2-7d35-4cbf-be3d-705b7135754d3
198040nitroglycerin 0.6 MG Sublingual TabletSCD5a36dac2-7d35-4cbf-be3d-705b7135754d3
198038nitroglycerin 300 MCG Sublingual TabletSY5a36dac2-7d35-4cbf-be3d-705b7135754d3
198039nitroglycerin 400 MCG Sublingual TabletSY5a36dac2-7d35-4cbf-be3d-705b7135754d3
198040nitroglycerin 600 MCG Sublingual TabletSY5a36dac2-7d35-4cbf-be3d-705b7135754d3
198038NTG 0.3 MG Sublingual TabletSY5a36dac2-7d35-4cbf-be3d-705b7135754d3
198039NTG 0.4 MG Sublingual TabletSY5a36dac2-7d35-4cbf-be3d-705b7135754d3
198040NTG 0.6 MG Sublingual TabletSY5a36dac2-7d35-4cbf-be3d-705b7135754d3
198038TNG 0.3 MG Sublingual TabletSY5a36dac2-7d35-4cbf-be3d-705b7135754d3
198039TNG 0.4 MG Sublingual TabletSY5a36dac2-7d35-4cbf-be3d-705b7135754d3
198040TNG 0.6 MG Sublingual TabletSY5a36dac2-7d35-4cbf-be3d-705b7135754d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72888-140-01728880140011 BOTTLE in 1 CARTON (72888-140-01) / 100 TABLET in 1 BOTTLE1 bottle2023-05-20NoNoHistorical