FDA.reportPublic FDA data

Nitroglycerin

Product NDC
60429-840
11-digit product format
604290840
Labeler code
60429
Product ID
60429-840_4b32b515-a550-088f-e063-6394a90a3ed0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitroglycerin
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA208191
Marketing category
ANDA
Marketing start
2016-08-26
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
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
60429-840-01Nitroglycerin100 in 1 BOTTLETABLET1005
60429-840-04Nitroglycerin4 in 1 CARTONTABLET45
60429-840-04Nitroglycerin25 in 1 BOTTLETABLET255

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60429-840-01EA - Each60429-840819eb62c-d045-48c9-bfb4-95221a0cc3e312017-05-04
60429-840-04EA - Each60429-840e17c4f76-c1dd-4545-b31d-e44a3d6e458512017-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60429-840NITROGLYCERIN TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]4Current NDC, Legacy NDC, 3 package rows20240726_df52ab34-e44c-46f3-8c44-2c1bcb93f28e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198038nitroglycerin 0.3 MG Sublingual TabletPSNdf52ab34-e44c-46f3-8c44-2c1bcb93f28e5
198039nitroglycerin 0.4 MG Sublingual TabletPSNdf52ab34-e44c-46f3-8c44-2c1bcb93f28e5
198040nitroglycerin 0.6 MG Sublingual TabletPSNdf52ab34-e44c-46f3-8c44-2c1bcb93f28e5
198038nitroglycerin 0.3 MG Sublingual TabletSCDdf52ab34-e44c-46f3-8c44-2c1bcb93f28e5
198039nitroglycerin 0.4 MG Sublingual TabletSCDdf52ab34-e44c-46f3-8c44-2c1bcb93f28e5
198040nitroglycerin 0.6 MG Sublingual TabletSCDdf52ab34-e44c-46f3-8c44-2c1bcb93f28e5
198038nitroglycerin 300 MCG Sublingual TabletSYdf52ab34-e44c-46f3-8c44-2c1bcb93f28e5
198039nitroglycerin 400 MCG Sublingual TabletSYdf52ab34-e44c-46f3-8c44-2c1bcb93f28e5
198040nitroglycerin 600 MCG Sublingual TabletSYdf52ab34-e44c-46f3-8c44-2c1bcb93f28e5
198038NTG 0.3 MG Sublingual TabletSYdf52ab34-e44c-46f3-8c44-2c1bcb93f28e5
198039NTG 0.4 MG Sublingual TabletSYdf52ab34-e44c-46f3-8c44-2c1bcb93f28e5
198040NTG 0.6 MG Sublingual TabletSYdf52ab34-e44c-46f3-8c44-2c1bcb93f28e5
198038TNG 0.3 MG Sublingual TabletSYdf52ab34-e44c-46f3-8c44-2c1bcb93f28e5
198039TNG 0.4 MG Sublingual TabletSYdf52ab34-e44c-46f3-8c44-2c1bcb93f28e5
198040TNG 0.6 MG Sublingual TabletSYdf52ab34-e44c-46f3-8c44-2c1bcb93f28e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60429-840-0160429084001100 TABLET in 1 BOTTLE (60429-840-01) 100 tablet2016-09-120000-00-00NoNoCurrent
60429-840-04604290840044 BOTTLE in 1 CARTON (60429-840-04) / 25 TABLET in 1 BOTTLE4 bottle2016-09-120000-00-00NoNoCurrent