FDA.reportPublic FDA data

nitroglycerin

Product NDC
70756-013
11-digit product format
707560013
Labeler code
70756
Product ID
70756-013_4efbd8db-727d-48a9-8c21-76fa0814dc9b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nitroglycerin
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
Lifestar Pharma LLC
Application
ANDA217970
Marketing category
ANDA
Marketing start
2023-12-05
Substance
NITROGLYCERIN
Active strength
.3 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.3 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
70756-013-11nitroglycerin100 in 1 BOTTLETABLET1004
70756-013-11nitroglycerin1 in 1 CARTONTABLET14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70756-013-11EA - Each70756-013bc8f8e35-3cf9-439b-8542-ad2b95b3bd1812024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70756-013NITROGLYCERIN TABLET [LIFESTAR PHARMA LLC]3Current NDC, 2 package rows20231214_38059df3-be1b-4226-9f12-c3c37cb44fea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198038nitroglycerin 0.3 MG Sublingual TabletPSN38059df3-be1b-4226-9f12-c3c37cb44fea4
198039nitroglycerin 0.4 MG Sublingual TabletPSN38059df3-be1b-4226-9f12-c3c37cb44fea4
198040nitroglycerin 0.6 MG Sublingual TabletPSN38059df3-be1b-4226-9f12-c3c37cb44fea4
198038nitroglycerin 0.3 MG Sublingual TabletSCD38059df3-be1b-4226-9f12-c3c37cb44fea4
198039nitroglycerin 0.4 MG Sublingual TabletSCD38059df3-be1b-4226-9f12-c3c37cb44fea4
198040nitroglycerin 0.6 MG Sublingual TabletSCD38059df3-be1b-4226-9f12-c3c37cb44fea4
198038nitroglycerin 300 MCG Sublingual TabletSY38059df3-be1b-4226-9f12-c3c37cb44fea4
198039nitroglycerin 400 MCG Sublingual TabletSY38059df3-be1b-4226-9f12-c3c37cb44fea4
198040nitroglycerin 600 MCG Sublingual TabletSY38059df3-be1b-4226-9f12-c3c37cb44fea4
198038NTG 0.3 MG Sublingual TabletSY38059df3-be1b-4226-9f12-c3c37cb44fea4
198039NTG 0.4 MG Sublingual TabletSY38059df3-be1b-4226-9f12-c3c37cb44fea4
198040NTG 0.6 MG Sublingual TabletSY38059df3-be1b-4226-9f12-c3c37cb44fea4
198038TNG 0.3 MG Sublingual TabletSY38059df3-be1b-4226-9f12-c3c37cb44fea4
198039TNG 0.4 MG Sublingual TabletSY38059df3-be1b-4226-9f12-c3c37cb44fea4
198040TNG 0.6 MG Sublingual TabletSY38059df3-be1b-4226-9f12-c3c37cb44fea4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70756-013-11707560013111 BOTTLE in 1 CARTON (70756-013-11) / 100 TABLET in 1 BOTTLE1 bottle2023-12-05NoNoHistorical