GONITRO

Product NDC
28595-705
11-digit product format
285950705
Labeler code
28595
Product ID
28595-705_7e58f2e8-89a3-4e86-b436-3999740cba16
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nitroglycerin
Dosage form
POWDER
Route
SUBLINGUAL
Labeler
Allegis Pharmaceuticals, Inc.
Application
NDA208424
Marketing category
NDA
Marketing start
2019-07-01
Marketing end
2023-06-30
Substance
NITROGLYCERIN
Active strength
400 ug/1
Pharmacologic classes
Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
28595-705-01EA - Each28595-705ad094426-ebc9-4c39-b31a-31675718b9ef12020-06-05
28595-705-36EA - Each28595-7056c56382c-8701-400e-a26c-03838b812ada12020-06-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
28595-705-122859507051212 PACKET in 1 BOX (28595-705-12) > 1 POWDER in 1 PACKET (28595-705-01) 12 packet2019-07-012023-06-30NoNoCurrent
28595-705-362859507053636 PACKET in 1 BOX (28595-705-36) > 1 POWDER in 1 PACKET36 packet2019-07-012023-06-30NoNoCurrent
28595-705-962859507059696 PACKET in 1 BOX (28595-705-96) > 1 POWDER in 1 PACKET96 packet2019-07-012023-06-30NoNoCurrent
28595-705-99285950705993 PACKET in 1 BOX (28595-705-99) > 1 POWDER in 1 PACKET3 packet2019-07-012023-06-30NoNoCurrent