FDA.reportPublic FDA data

NITROGLYCERIN

Product NDC
69339-174
11-digit product format
693390174
Labeler code
69339
Product ID
69339-174_aeb4c868-1d42-4183-b86f-4ae1dc0aa6d3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NITROGLYCERIN
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
Natco Pharma USA LLC
Application
ANDA211604
Marketing category
ANDA
Marketing start
2022-10-03
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
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
69339-174-01NITROGLYCERIN100 in 1 BOTTLETABLET1004
69339-174-01NITROGLYCERIN1 in 1 CARTONTABLET14
69339-174-02NITROGLYCERIN25 in 1 BOTTLETABLET254
69339-174-41NITROGLYCERIN4 in 1 CARTONTABLET44

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69339-174-01EA - Each69339-17406fd9316-dfdc-439c-86d1-22581dcdb40212022-10-06
69339-174-02EA - Each69339-174561a0d15-973f-4d85-905b-5e6630a4f26212022-10-06
69339-174-41EA - Each69339-1745f645163-a1bf-446c-8272-81d7cbd31b1412022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69339-174NITROGLYCERIN TABLET [NATCO PHARMA USA LLC]4Current NDC, Legacy NDC, 4 package rows20230922_941ac242-120e-47c1-ac03-50026ff93dd6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198039nitroglycerin 0.4 MG Sublingual TabletPSNf9b52553-5a26-d374-e053-6294a90a40c76
198039nitroglycerin 0.4 MG Sublingual TabletSCDf9b52553-5a26-d374-e053-6294a90a40c76
198039nitroglycerin 400 MCG Sublingual TabletSYf9b52553-5a26-d374-e053-6294a90a40c76
198039NTG 0.4 MG Sublingual TabletSYf9b52553-5a26-d374-e053-6294a90a40c76
198039TNG 0.4 MG Sublingual TabletSYf9b52553-5a26-d374-e053-6294a90a40c76
198038nitroglycerin 0.3 MG Sublingual TabletPSN941ac242-120e-47c1-ac03-50026ff93dd64
198039nitroglycerin 0.4 MG Sublingual TabletPSN941ac242-120e-47c1-ac03-50026ff93dd64
198040nitroglycerin 0.6 MG Sublingual TabletPSN941ac242-120e-47c1-ac03-50026ff93dd64
198038nitroglycerin 0.3 MG Sublingual TabletSCD941ac242-120e-47c1-ac03-50026ff93dd64
198039nitroglycerin 0.4 MG Sublingual TabletSCD941ac242-120e-47c1-ac03-50026ff93dd64
198040nitroglycerin 0.6 MG Sublingual TabletSCD941ac242-120e-47c1-ac03-50026ff93dd64
198038nitroglycerin 300 MCG Sublingual TabletSY941ac242-120e-47c1-ac03-50026ff93dd64
198039nitroglycerin 400 MCG Sublingual TabletSY941ac242-120e-47c1-ac03-50026ff93dd64
198040nitroglycerin 600 MCG Sublingual TabletSY941ac242-120e-47c1-ac03-50026ff93dd64
198038NTG 0.3 MG Sublingual TabletSY941ac242-120e-47c1-ac03-50026ff93dd64
198039NTG 0.4 MG Sublingual TabletSY941ac242-120e-47c1-ac03-50026ff93dd64
198040NTG 0.6 MG Sublingual TabletSY941ac242-120e-47c1-ac03-50026ff93dd64
198038TNG 0.3 MG Sublingual TabletSY941ac242-120e-47c1-ac03-50026ff93dd64
198039TNG 0.4 MG Sublingual TabletSY941ac242-120e-47c1-ac03-50026ff93dd64
198040TNG 0.6 MG Sublingual TabletSY941ac242-120e-47c1-ac03-50026ff93dd64
198039nitroglycerin 0.4 MG Sublingual TabletPSNf4ea9ad1-a71f-7cea-e053-2a95a90a106d2
198039nitroglycerin 0.4 MG Sublingual TabletPSN84739085-81df-4a43-8456-c9edfbf971e92
198039nitroglycerin 0.4 MG Sublingual TabletSCD84739085-81df-4a43-8456-c9edfbf971e92
198039nitroglycerin 0.4 MG Sublingual TabletSCDf4ea9ad1-a71f-7cea-e053-2a95a90a106d2
198039nitroglycerin 400 MCG Sublingual TabletSY84739085-81df-4a43-8456-c9edfbf971e92
198039nitroglycerin 400 MCG Sublingual TabletSYf4ea9ad1-a71f-7cea-e053-2a95a90a106d2
198039NTG 0.4 MG Sublingual TabletSYf4ea9ad1-a71f-7cea-e053-2a95a90a106d2
198039NTG 0.4 MG Sublingual TabletSY84739085-81df-4a43-8456-c9edfbf971e92
198039TNG 0.4 MG Sublingual TabletSYf4ea9ad1-a71f-7cea-e053-2a95a90a106d2
198039TNG 0.4 MG Sublingual TabletSY84739085-81df-4a43-8456-c9edfbf971e92
198039nitroglycerin 0.4 MG Sublingual TabletPSN3dd022d8-c224-d19f-e063-6394a90adca41
198039nitroglycerin 0.4 MG Sublingual TabletPSN160b85ac-d964-463b-9f1e-1429f14ed3181
198039nitroglycerin 0.4 MG Sublingual TabletSCD160b85ac-d964-463b-9f1e-1429f14ed3181
198039nitroglycerin 0.4 MG Sublingual TabletSCD3dd022d8-c224-d19f-e063-6394a90adca41
198039nitroglycerin 400 MCG Sublingual TabletSY3dd022d8-c224-d19f-e063-6394a90adca41
198039nitroglycerin 400 MCG Sublingual TabletSY160b85ac-d964-463b-9f1e-1429f14ed3181
198039NTG 0.4 MG Sublingual TabletSY160b85ac-d964-463b-9f1e-1429f14ed3181
198039NTG 0.4 MG Sublingual TabletSY3dd022d8-c224-d19f-e063-6394a90adca41
198039TNG 0.4 MG Sublingual TabletSY3dd022d8-c224-d19f-e063-6394a90adca41
198039TNG 0.4 MG Sublingual TabletSY160b85ac-d964-463b-9f1e-1429f14ed3181

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69339-174-01693390174011 BOTTLE in 1 CARTON (69339-174-01) / 100 TABLET in 1 BOTTLE1 bottle2022-10-030000-00-00NoNoCurrent
69339-174-026933901740225 in 1 BOTTLEHistorical
69339-174-41693390174414 BOTTLE in 1 CARTON (69339-174-41) / 25 TABLET in 1 BOTTLE (69339-174-02) 4 bottle2022-10-030000-00-00NoNoCurrent