FDA.reportPublic FDA data

Nitroglycerin

Product NDC
71205-225
11-digit product format
712050225
Labeler code
71205
Product ID
71205-225_8c1a4a70-9849-4cb2-9425-5cf5747d4fbc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitroglycerin
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
Proficient Rx LP
Application
ANDA208191
Marketing category
ANDA
Marketing start
2016-08-29
Substance
NITROGLYCERIN
Active strength
.4 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.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
71205-225-25Nitroglycerin25 in 1 BOTTLETABLET254
71205-225-30Nitroglycerin30 in 1 BOTTLETABLET304
71205-225-60Nitroglycerin60 in 1 BOTTLETABLET604
71205-225-90Nitroglycerin90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-225-25EA - Each71205-225342a2956-e9cb-4f82-889a-5dffe2320cbd12019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-225NITROGLYCERIN TABLET [PROFICIENT RX LP]4Current NDC, Legacy NDC, 4 package rows20220726_67a15ee9-a6ae-4a60-8333-e06c608cfd71.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198039nitroglycerin 0.4 MG Sublingual TabletPSN67a15ee9-a6ae-4a60-8333-e06c608cfd714
198039nitroglycerin 0.4 MG Sublingual TabletSCD67a15ee9-a6ae-4a60-8333-e06c608cfd714
198039nitroglycerin 400 MCG Sublingual TabletSY67a15ee9-a6ae-4a60-8333-e06c608cfd714
198039NTG 0.4 MG Sublingual TabletSY67a15ee9-a6ae-4a60-8333-e06c608cfd714
198039TNG 0.4 MG Sublingual TabletSY67a15ee9-a6ae-4a60-8333-e06c608cfd714

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-225-257120502252525 TABLET in 1 BOTTLE (71205-225-25) 25 tablet2019-02-010000-00-00NoNoCurrent
71205-225-307120502253030 TABLET in 1 BOTTLE (71205-225-30) 30 tablet2019-02-010000-00-00NoNoCurrent
71205-225-607120502256060 TABLET in 1 BOTTLE (71205-225-60) 60 tablet2019-02-010000-00-00NoNoCurrent
71205-225-907120502259090 TABLET in 1 BOTTLE (71205-225-90) 90 tablet2019-02-010000-00-00NoNoCurrent