FDA.reportPublic FDA data

Nitroglycerin

Product NDC
50090-6818
11-digit product format
500906818
Labeler code
50090
Product ID
50090-6818_93bd2b9d-b78f-42b1-abc5-69f8eeb50741
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitroglycerin
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
A-S Medication Solutions
Application
ANDA206391
Marketing category
ANDA
Marketing start
2017-09-19
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
50090-6818-0Nitroglycerin4 in 1 CARTONTABLET44
50090-6818-0Nitroglycerin25 in 1 BOTTLETABLET254
50090-6818-1Nitroglycerin25 in 1 BOTTLETABLET254

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6818NITROGLYCERIN TABLET [A-S MEDICATION SOLUTIONS]2Current NDC, 3 package rows20231122_532e30c4-cbda-4450-b0a0-e08601c202fb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198039nitroglycerin 0.4 MG Sublingual TabletPSN532e30c4-cbda-4450-b0a0-e08601c202fb4
198039nitroglycerin 0.4 MG Sublingual TabletSCD532e30c4-cbda-4450-b0a0-e08601c202fb4
198039nitroglycerin 400 MCG Sublingual TabletSY532e30c4-cbda-4450-b0a0-e08601c202fb4
198039NTG 0.4 MG Sublingual TabletSY532e30c4-cbda-4450-b0a0-e08601c202fb4
198039TNG 0.4 MG Sublingual TabletSY532e30c4-cbda-4450-b0a0-e08601c202fb4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6818-0500906818004 BOTTLE in 1 CARTON (50090-6818-0) / 25 TABLET in 1 BOTTLE4 bottle2023-11-15NoNoCurrent
50090-6818-15009068180125 TABLET in 1 BOTTLE (50090-6818-1) 25 tablet2023-11-14NoNoCurrent