FDA.reportPublic FDA data

Nitroglycerin

Product NDC
43547-986
11-digit product format
435470986
Labeler code
43547
Product ID
43547-986_6624eac6-c803-45d1-ad99-8ffa6c5a5ac9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitroglycerin
Dosage form
TABLET
Route
SUBLINGUAL
Labeler
Solco Healthcare U.S., LLC
Application
ANDA218583
Marketing category
ANDA
Marketing start
2025-06-01
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
43547-986-04Nitroglycerin25 in 1 BOTTLETABLET253
43547-986-04Nitroglycerin4 in 1 CARTONTABLET43
43547-986-10Nitroglycerin1 in 1 CARTONTABLET13
43547-986-10Nitroglycerin100 in 1 BOTTLETABLET1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43547-986-04EA - Each43547-9864fb1b961-eae0-4819-a956-b8e707b8bdcd12025-11-13
43547-986-10EA - Each43547-9862cdd5a45-c4d6-4472-b453-d0948544f6fb12025-11-13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198038nitroglycerin 0.3 MG Sublingual TabletPSN61759752-dd07-4bed-8079-b578e39305193
198039nitroglycerin 0.4 MG Sublingual TabletPSN61759752-dd07-4bed-8079-b578e39305193
198040nitroglycerin 0.6 MG Sublingual TabletPSN61759752-dd07-4bed-8079-b578e39305193
198038nitroglycerin 0.3 MG Sublingual TabletSCD61759752-dd07-4bed-8079-b578e39305193
198039nitroglycerin 0.4 MG Sublingual TabletSCD61759752-dd07-4bed-8079-b578e39305193
198040nitroglycerin 0.6 MG Sublingual TabletSCD61759752-dd07-4bed-8079-b578e39305193
198038nitroglycerin 300 MCG Sublingual TabletSY61759752-dd07-4bed-8079-b578e39305193
198039nitroglycerin 400 MCG Sublingual TabletSY61759752-dd07-4bed-8079-b578e39305193
198040nitroglycerin 600 MCG Sublingual TabletSY61759752-dd07-4bed-8079-b578e39305193
198038NTG 0.3 MG Sublingual TabletSY61759752-dd07-4bed-8079-b578e39305193
198039NTG 0.4 MG Sublingual TabletSY61759752-dd07-4bed-8079-b578e39305193
198040NTG 0.6 MG Sublingual TabletSY61759752-dd07-4bed-8079-b578e39305193
198038TNG 0.3 MG Sublingual TabletSY61759752-dd07-4bed-8079-b578e39305193
198039TNG 0.4 MG Sublingual TabletSY61759752-dd07-4bed-8079-b578e39305193
198040TNG 0.6 MG Sublingual TabletSY61759752-dd07-4bed-8079-b578e39305193

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43547-986-04435470986044 BOTTLE in 1 CARTON (43547-986-04) / 25 TABLET in 1 BOTTLE4 bottle2025-06-01NoNoCurrent
43547-986-10435470986101 BOTTLE in 1 CARTON (43547-986-10) / 100 TABLET in 1 BOTTLE1 bottle2025-06-01NoNoCurrent