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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A218235-001NITROGLYCERINNITROGLYCERIN2%OINTMENT / TRANSDERMALAB2025-04-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A218235-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A218235-001NITROGLYCERIN2%OINTMENT / TRANSDERMALAB2025-04-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218235-001NITROGLYCERIN2%OINTMENT / TRANSDERMALAB2025-04-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A218235-001NITROGLYCERIN2%OINTMENT / TRANSDERMALAB2025-04-156a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218235-001NITROGLYCERIN2%OINTMENT / TRANSDERMALAB2025-04-15a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A218235-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218235-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A218235-001AB16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218235-001AB1a50c72e98297…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G59M7S0WS3Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
242946Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c17c997b-0e90-4105-888b-2de22d2bf697Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NITROGLYCERINNITROGLYCERINEncube Ethicals, Inc.c17c997b-0e90-4105-888b-2de22d2bf6972026-05-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218235
application number: ANDA218235
ndc (product): 21922-054

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 tube2025-04-16NoNoCurrent
21922-054-472192200544748 POUCH in 1 CARTON (21922-054-47) / 1 g in 1 POUCH (21922-054-59) 48 pouch2025-04-16NoNoCurrent
21922-054-59219220054591 g in 1 POUCH1 gHistorical