Nitroglycerin

Product NDC
68462-638
11-digit product format
684620638
Labeler code
68462
Product ID
68462-638_76e69387-efc6-4816-972c-765cb260b34a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitroglycerin
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA206391
Marketing category
ANDA
Marketing start
2017-08-19
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
68462-638-01Nitroglycerin100 in 1 BOTTLETABLET10010
68462-638-01Nitroglycerin1 in 1 CARTONTABLET110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-638-01EA - Each68462-63891ed9a77-7b50-4665-acd9-e31256e672e912017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-638NITROGLYCERIN TABLET [GLENMARK PHARMACEUTICALS INC., USA]9Current NDC, Legacy NDC, 2 package rows20240104_fa789d65-9407-4965-bd06-4457444b42be.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198038nitroglycerin 0.3 MG Sublingual TabletPSNfa789d65-9407-4965-bd06-4457444b42be10
198039nitroglycerin 0.4 MG Sublingual TabletPSNfa789d65-9407-4965-bd06-4457444b42be10
198040nitroglycerin 0.6 MG Sublingual TabletPSNfa789d65-9407-4965-bd06-4457444b42be10
198038nitroglycerin 0.3 MG Sublingual TabletSCDfa789d65-9407-4965-bd06-4457444b42be10
198039nitroglycerin 0.4 MG Sublingual TabletSCDfa789d65-9407-4965-bd06-4457444b42be10
198040nitroglycerin 0.6 MG Sublingual TabletSCDfa789d65-9407-4965-bd06-4457444b42be10
198038nitroglycerin 300 MCG Sublingual TabletSYfa789d65-9407-4965-bd06-4457444b42be10
198039nitroglycerin 400 MCG Sublingual TabletSYfa789d65-9407-4965-bd06-4457444b42be10
198040nitroglycerin 600 MCG Sublingual TabletSYfa789d65-9407-4965-bd06-4457444b42be10
198038NTG 0.3 MG Sublingual TabletSYfa789d65-9407-4965-bd06-4457444b42be10
198039NTG 0.4 MG Sublingual TabletSYfa789d65-9407-4965-bd06-4457444b42be10
198040NTG 0.6 MG Sublingual TabletSYfa789d65-9407-4965-bd06-4457444b42be10
198038TNG 0.3 MG Sublingual TabletSYfa789d65-9407-4965-bd06-4457444b42be10
198039TNG 0.4 MG Sublingual TabletSYfa789d65-9407-4965-bd06-4457444b42be10
198040TNG 0.6 MG Sublingual TabletSYfa789d65-9407-4965-bd06-4457444b42be10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-638-01684620638011 BOTTLE in 1 CARTON (68462-638-01) / 100 TABLET in 1 BOTTLE1 bottle2017-08-190000-00-00NoNoCurrent