FDA.reportPublic FDA data

NITROGLYCERIN

Product NDC
21922-054
11-digit product format
219220054
Labeler code
21922
Product ID
21922-054_4ebf07d0-9435-4756-b67d-23ed0fcd4279
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitroglycerin
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Encube Ethicals, Inc.
Application
ANDA218235
Marketing category
ANDA
Marketing start
2025-04-16
Substance
NITROGLYCERIN
Active strength
20 mg/g
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NITROGLYCERIN20 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG59M7S0WS3
Rxcui242946

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
21922-054-05NITROGLYCERIN1 in 1 CARTONOINTMENT14
21922-054-05NITROGLYCERIN30 g in 1 TUBEOINTMENT304
21922-054-47NITROGLYCERIN48 in 1 CARTONOINTMENT484
21922-054-59NITROGLYCERIN1 g in 1 POUCHOINTMENT14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21922-054-05GM - Gram21922-054f86d7394-1303-4a3b-94b4-0a41c76a294c12026-04-20
21922-054-47GM - Gram21922-0542661ee23-7859-4dd1-92f2-45c3d1a694d812026-04-20
21922-054-59GM - Gram21922-054532e72d4-1863-439a-a876-b069250376c512026-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21922-054NITROGLYCERIN OINTMENT [ENCUBE ETHICALS PRIVATE LIMITED]3Current NDC, 4 package rows20250419_c17c997b-0e90-4105-888b-2de22d2bf697.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
21922-054-05219220054051 TUBE in 1 CARTON (21922-054-05) / 30 g in 1 TUBE1 tube2025-04-16NoNoHistorical
21922-054-472192200544748 POUCH in 1 CARTON (21922-054-47) / 1 g in 1 POUCH (21922-054-59) 48 pouch2025-04-16NoNoHistorical
21922-054-59219220054591 g in 1 POUCH1 gHistorical