FDA.reportPublic FDA data

Nitroglycerin

Product NDC
73473-500
11-digit product format
734730500
Labeler code
73473
Product ID
73473-500_fa800efb-4cb4-44bf-9ec9-f35a32476022
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitroglycerin
Dosage form
OINTMENT
Route
RECTAL
Labeler
Solaris Pharma Corporation
Application
ANDA218756
Marketing category
ANDA
Marketing start
2026-01-08
Substance
NITROGLYCERIN
Active strength
4 mg/g
Pharmacologic classes
Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
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
A218756-001NITROGLYCERINNITROGLYCERIN0.4%OINTMENT / INTRA-ANALAB2025-12-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A218756-001AB

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 UTC2026-02A218756-001NITROGLYCERIN0.4%OINTMENT / INTRA-ANALAB2025-12-18011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218756-001NITROGLYCERIN0.4%OINTMENT / INTRA-ANALAB2025-12-18a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A218756-001AB1011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218756-001AB1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Nitroglycerin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NITROGLYCERIN4 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
1114466Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f0a76edb-9e63-4aa4-9362-7375c799b2b5Available 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
73473-500-30Nitroglycerin30 g in 1 TUBEOINTMENT306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73473-500-30GM - Gram73473-500844c2293-5a7b-42e8-9dd5-626a9f7abbfc12026-02-05

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NitroglycerinNITROGLYCERINBryant Ranch Prepack7cf08521-aaf6-4129-9f8e-077d6282fbc62026-05-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218756
application number: ANDA218756
NitroglycerinNITROGLYCERINSolaris Pharma Corporationf0a76edb-9e63-4aa4-9362-7375c799b2b52025-12-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218756
application number: ANDA218756
ndc (product): 73473-500

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1114466nitroglycerin 0.4 % Rectal OintmentPSN7cf08521-aaf6-4129-9f8e-077d6282fbc6100
1114466nitroglycerin 0.004 MG/MG Rectal OintmentSCD7cf08521-aaf6-4129-9f8e-077d6282fbc6100
1114466nitroglycerin 0.4 % Rectal OintmentSY7cf08521-aaf6-4129-9f8e-077d6282fbc6100
1114466NTG 0.004 MG/MG Rectal OintmentSY7cf08521-aaf6-4129-9f8e-077d6282fbc6100
1114466TNG 0.004 MG/MG Rectal OintmentSY7cf08521-aaf6-4129-9f8e-077d6282fbc6100
1114466nitroglycerin 0.4 % Rectal OintmentPSNf0a76edb-9e63-4aa4-9362-7375c799b2b56
1114466nitroglycerin 0.004 MG/MG Rectal OintmentSCDf0a76edb-9e63-4aa4-9362-7375c799b2b56
1114466nitroglycerin 0.4 % Rectal OintmentSYf0a76edb-9e63-4aa4-9362-7375c799b2b56
1114466NTG 0.004 MG/MG Rectal OintmentSYf0a76edb-9e63-4aa4-9362-7375c799b2b56
1114466TNG 0.004 MG/MG Rectal OintmentSYf0a76edb-9e63-4aa4-9362-7375c799b2b56

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
73473-500-307347305003030 g in 1 TUBE (73473-500-30) 30 g2026-01-08NoNoCurrent