FDA.reportPublic FDA data

nitroglycerin

Product NDC
70518-4277
11-digit product format
705184277
Labeler code
70518
Product ID
70518-4277_40198521-d59a-4641-e063-6294a90a7b48
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nitroglycerin
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
REMEDYREPACK INC.
Application
ANDA217970
Marketing category
ANDA
Marketing start
2025-02-05
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
70518-4277-0nitroglycerin1 in 1 CARTONTABLET14
70518-4277-0nitroglycerin100 in 1 BOTTLETABLET1004
70518-4277-1nitroglycerin25 in 1 BOTTLETABLET254
70518-4277-1nitroglycerin4 in 1 CARTONTABLET44

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4277NITROGLYCERIN TABLET [REMEDYREPACK INC.]3Current NDC, 4 package rows20250212_89da40c1-bab1-422e-b326-8ebcbdbc81f3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198039nitroglycerin 0.4 MG Sublingual TabletPSN89da40c1-bab1-422e-b326-8ebcbdbc81f34
198039nitroglycerin 0.4 MG Sublingual TabletSCD89da40c1-bab1-422e-b326-8ebcbdbc81f34
198039nitroglycerin 400 MCG Sublingual TabletSY89da40c1-bab1-422e-b326-8ebcbdbc81f34
198039NTG 0.4 MG Sublingual TabletSY89da40c1-bab1-422e-b326-8ebcbdbc81f34
198039TNG 0.4 MG Sublingual TabletSY89da40c1-bab1-422e-b326-8ebcbdbc81f34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4277-0705184277001 BOTTLE in 1 CARTON (70518-4277-0) / 100 TABLET in 1 BOTTLE1 bottle2025-02-05NoNoCurrent
70518-4277-1705184277014 BOTTLE in 1 CARTON (70518-4277-1) / 25 TABLET in 1 BOTTLE4 bottle2025-02-08NoNoCurrent