Nitroglycerin

Product NDC
43478-410
11-digit product format
434780410
Labeler code
43478
Product ID
43478-410_905b7ddc-f00a-4303-9a62-8e4933bffc82
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nitroglycerin
Dosage form
AEROSOL, METERED
Route
SUBLINGUAL
Labeler
Rouses Point Pharm
Application
NDA021780
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2012-10-16
Marketing end
0000-00-00
Substance
NITROGLYCERIN
Active strength
400 ug/1
Pharmacologic classes
Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct43478-410IInactivated by FDA2026-10-05
excluded packagepackage43478-41043478-410-03IInactivated by FDA2026-10-05
excluded packagepackage43478-41043478-410-07IInactivated by FDA2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 54 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43478-410-07d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43478-410-03d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43478-410-07f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43478-410-03f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43478-410-072ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43478-410-032ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43478-410-07a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43478-410-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43478-410-07cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43478-410-03cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43478-410-07cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43478-410-03cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage43478-410-07302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage43478-410-03302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage43478-410-07ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage43478-410-03ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage43478-410-070efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage43478-410-030efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage43478-410-07ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage43478-410-03ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage43478-410-07367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage43478-410-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage43478-410-07557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage43478-410-03557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage43478-410-078af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage43478-410-038af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage43478-410-07834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage43478-410-03834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage43478-410-071332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage43478-410-031332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage43478-410-07fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage43478-410-03fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage43478-410-0786f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage43478-410-0386f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage43478-410-07bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage43478-410-03bd6a592717d7…303034d00443…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N021780-001NITROMISTNITROGLYCERIN0.4MG/SPRAYAEROSOL, METERED / SUBLINGUALRLD, RS2006-11-02

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.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N021780-001NITROMIST0.4MG/SPRAYAEROSOL, METERED / SUBLINGUALRLD, RS2006-11-0284e616aacf4f…
2026-08-18 06:07:402026-07N021780-001NITROMIST0.4MG/SPRAYAEROSOL, METERED / SUBLINGUALRLD, RS2006-11-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021780-001NITROMIST0.4MG/SPRAYAEROSOL, METERED / SUBLINGUALRLD, RS2006-11-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021780-001NITROMIST0.4MG/SPRAYAEROSOL, METERED / SUBLINGUALRLD, RS2006-11-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08N021780-001NITROMIST0.4MG/SPRAYAEROSOL, METERED / SUBLINGUALRLD, RS2006-11-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021780-001NITROMIST0.4MG/SPRAYAEROSOL, METERED / SUBLINGUALRLD, RS2006-11-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021780-001NITROMIST0.4MG/SPRAYAEROSOL, METERED / SUBLINGUALRLD, RS2006-11-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021780-001NITROMIST0.4MG/SPRAYAEROSOL, METERED / SUBLINGUALRLD, RS2006-11-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021780-001NITROMIST0.4MG/SPRAYAEROSOL, METERED / SUBLINGUALRLD, RS2006-11-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021780-001NITROMIST0.4MG/SPRAYAEROSOL, METERED / SUBLINGUALRLD, RS2006-11-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021780-001NITROMIST0.4MG/SPRAYAEROSOL, METERED / SUBLINGUALRLD, RS2006-11-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021780-001NITROMIST0.4MG/SPRAYAEROSOL, METERED / SUBLINGUALRLD, RS2006-11-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021780-001NITROMIST0.4MG/SPRAYAEROSOL, METERED / SUBLINGUALRLD, RS2006-11-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021780-001NITROMIST0.4MG/SPRAYAEROSOL, METERED / SUBLINGUALRLD, RS2006-11-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021780-001NITROMIST0.4MG/SPRAYAEROSOL, METERED / SUBLINGUALRLD, RS2006-11-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021780-001NITROMIST0.4MG/SPRAYAEROSOL, METERED / SUBLINGUALRLD, RS2006-11-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021780-001NITROMIST0.4MG/SPRAYAEROSOL, METERED / SUBLINGUALRLD, RS2006-11-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021780-001NITROMIST0.4MG/SPRAYAEROSOL, METERED / SUBLINGUALRLD, RS2006-11-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021780-001NITROMIST0.4MG/SPRAYAEROSOL, METERED / SUBLINGUALRLD, RS2006-11-024b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021780-001NITROMIST0.4MG/SPRAYAEROSOL, METERED / SUBLINGUALRLD, RS2006-11-0274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021780-001NITROMIST0.4MG/SPRAYAEROSOL, METERED / SUBLINGUALRLD, RS2006-11-02bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021780-001NITROMIST0.4MG/SPRAYAEROSOL, METERED / SUBLINGUALRLD, RS2006-11-02782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021780-001NITROMIST0.4MG/SPRAYAEROSOL, METERED / SUBLINGUALRLD, RS2006-11-0287673890dc5c…
2021-03-12 10:30 UTC2021-03N021780-001NITROMIST0.4MG/SPRAYAEROSOL, METERED / SUBLINGUALRLD, RS2006-11-025aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021780-001NITROMIST0.4MG/SPRAYAEROSOL, METERED / SUBLINGUALRLD, RS2006-11-028869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021780-001NITROMIST0.4MG/SPRAYAEROSOL, METERED / SUBLINGUALRLD, RS2006-11-02c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021780-001NITROMIST0.4MG/SPRAYAEROSOL, METERED / SUBLINGUALRLD, RS2006-11-023f01610625f2…
2019-09-15 20:21 UTC2019-09N021780-001NITROMIST0.4MG/SPRAYAEROSOL, METERED / SUBLINGUALRLD, RS2006-11-02b00525d2431f…
2019-07-19 19:46 UTC2019-07N021780-001NITROMIST0.4MG/SPRAYAEROSOL, METERED / SUBLINGUALRLD, RS2006-11-02ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021780-001NITROMIST0.4MG/SPRAYAEROSOL, METERED / SUBLINGUALRLD, RS2006-11-026a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021780-001NITROMIST0.4MG/SPRAYAEROSOL, METERED / SUBLINGUALRLD, RS2006-11-021c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021780-001NITROMIST0.4MG/SPRAYAEROSOL, METERED / SUBLINGUALRLD, RS2006-11-02ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021780-001NITROMIST0.4MG/SPRAYAEROSOL, METERED / SUBLINGUALRLD, RS2006-11-02a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021780-001NITROMIST0.4MG/SPRAYAEROSOL, METERED / SUBLINGUALRLD, RS2006-11-029b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021780-001NITROMIST0.4MG/SPRAYAEROSOL, METERED / SUBLINGUALRLD, RS2006-11-02a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021780-001NITROMIST0.4MG/SPRAYAEROSOL, METERED / SUBLINGUALRLD, RS2006-11-023f0d92c62455…
2023-05-13 08:27 UTC2023-05N021780-001NITROMIST0.4MG/SPRAYAEROSOL, METERED / SUBLINGUALRLD, RS2006-11-02053a50430f4f…
2023-01-26 05:58 UTC2023-01N021780-001NITROMIST0.4MG/SPRAYAEROSOL, METERED / SUBLINGUALRLD, RS2006-11-023bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021780-001NITROMIST0.4MG/SPRAYAEROSOL, METERED / SUBLINGUALRLD, RS2006-11-023a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021780-001NITROMIST0.4MG/SPRAYAEROSOL, METERED / SUBLINGUALRLD, RS2006-11-02f41ea6bd6efb…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43478-410-03Nitroglycerin1 in 1 CARTONAEROSOL, METERED13
43478-410-03Nitroglycerin60 in 1 BOTTLEAEROSOL, METERED603
43478-410-07Nitroglycerin1 in 1 CARTONAEROSOL, METERED13
43478-410-07Nitroglycerin200 in 1 BOTTLEAEROSOL, METERED2003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43478-410-03GM - Gram43478-41003c4714c-616b-4501-ae25-4526b6b7d83c12013-02-13
43478-410-07GM - Gram43478-410b2cfb3b8-dc6e-4213-a0a2-415e61eb1c3b12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NITROGLYCERINACTIVE INGREDIENTG59M7S0WS3NITROGLYCERIN AEROSOL, METERED [ROUSES POINT PHARM]2
NITROGLYCERINACTIVE MOIETYG59M7S0WS3NITROGLYCERIN AEROSOL, METERED [ROUSES POINT PHARM]2
BUTANEINACTIVE INGREDIENT6LV4FOR43RNITROGLYCERIN AEROSOL, METERED [ROUSES POINT PHARM]2
CAPRYLIC/CAPRIC/SUCCINIC TRIGLYCERIDEINACTIVE INGREDIENTJ4BY50FL78NITROGLYCERIN AEROSOL, METERED [ROUSES POINT PHARM]2
MENTHOLINACTIVE INGREDIENTL7T10EIP3ANITROGLYCERIN AEROSOL, METERED [ROUSES POINT PHARM]2
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JHNITROGLYCERIN AEROSOL, METERED [ROUSES POINT PHARM]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43478-410NITROGLYCERIN AEROSOL, METERED [ROUSES POINT PHARM]3Legacy NDC, 4 package rows20160923_3214ddac-e068-4306-8500-0fa90c8c5842.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
705129nitroglycerin 400 MCG/ACTUAT Mucosal SprayPSN3214ddac-e068-4306-8500-0fa90c8c58423
705129nitroglycerin 0.4 MG/ACTUAT Mucosal SpraySCD3214ddac-e068-4306-8500-0fa90c8c58423
705129nitroglycerin 400 MCG/ACTUAT Mucosal SpraySY3214ddac-e068-4306-8500-0fa90c8c58423
705129nitroglycerin 400 MCG/ACTUAT Oral SpraySY3214ddac-e068-4306-8500-0fa90c8c58423
705129nitroglycerin 400 MCG/ACTUAT Sublingual SpraySY3214ddac-e068-4306-8500-0fa90c8c58423
705129NTG 0.4 MG/ACTUAT Mucosal SpraySY3214ddac-e068-4306-8500-0fa90c8c58423
705129TNG 0.4 MG/ACTUAT Mucosal SpraySY3214ddac-e068-4306-8500-0fa90c8c58423

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43478-410-03434780410031 BOTTLE in 1 CARTON (43478-410-03) > 60 AEROSOL, METERED in 1 BOTTLE1 bottle2012-10-160000-00-00NoNoCurrent
43478-410-07434780410071 BOTTLE in 1 CARTON (43478-410-07) > 200 AEROSOL, METERED in 1 BOTTLE1 bottle2012-10-160000-00-00NoNoCurrent