Nitroglycerin Transdermal Delivery System

Product NDC
29336-323
11-digit product format
293360323
Labeler code
29336
Product ID
29336-323_590f4d2a-cb56-0b3e-4301-7bf5c148e3a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nitroglycerin
Dosage form
PATCH
Route
TRANSDERMAL
Labeler
Graceway Pharmaceuticals, LLC
Application
ANDA089773
Marketing category
ANDA
Marketing start
2007-04-04
Marketing end
0000-00-00
Substance
NITROGLYCERIN
Active strength
10 mg/d
Pharmacologic classes
Nitrate Vasodilator [EPC],Nitrates [CS],Vasodilation [PE]
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct29336-323IInactivated by FDA2026-08-11
excluded packagepackage29336-32329336-323-30IInactivated by FDA2026-08-11

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 · 44 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 packagepackage29336-323-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage29336-323-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage29336-323-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage29336-323-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage29336-323-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage29336-323-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage29336-323-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage29336-323-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage29336-323-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage29336-323-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage29336-323-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage29336-323-30557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage29336-323-308af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage29336-323-30834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage29336-323-301332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage29336-323-30fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage29336-323-3086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage29336-323-30bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage29336-323-308dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage29336-323-30e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage29336-323-309bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage29336-323-30110d247fa046…a55b01930146…

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
A089773-001MINITRANNITROGLYCERIN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMAL1996-08-30

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A089773-001MINITRAN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMAL1996-08-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089773-001MINITRAN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMAL1996-08-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A089773-001MINITRAN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMAL1996-08-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089773-001MINITRAN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMAL1996-08-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089773-001MINITRAN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMAL1996-08-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089773-001MINITRAN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMAL1996-08-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089773-001MINITRAN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMAL1996-08-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089773-001MINITRAN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMAL1996-08-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089773-001MINITRAN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMAL1996-08-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A089773-001MINITRAN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMAL1996-08-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A089773-001MINITRAN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMAL1996-08-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A089773-001MINITRAN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMAL1996-08-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A089773-001MINITRAN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMAL1996-08-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A089773-001MINITRAN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMAL1996-08-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A089773-001MINITRAN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMAL1996-08-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A089773-001MINITRAN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMAL1996-08-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A089773-001MINITRAN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMAL1996-08-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A089773-001MINITRAN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMAL1996-08-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A089773-001MINITRAN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMAL1996-08-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A089773-001MINITRAN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMAL1996-08-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A089773-001MINITRAN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMAL1996-08-3087673890dc5c…
2021-03-12 10:30 UTC2021-03A089773-001MINITRAN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMAL1996-08-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A089773-001MINITRAN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMAL1996-08-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11A089773-001MINITRAN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMAL1996-08-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12A089773-001MINITRAN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMAL1996-08-303f01610625f2…
2019-09-15 20:21 UTC2019-09A089773-001MINITRAN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMAL1996-08-30b00525d2431f…
2019-07-19 19:46 UTC2019-07A089773-001MINITRAN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMAL1996-08-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A089773-001MINITRAN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMAL1996-08-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A089773-001MINITRAN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMAL1996-08-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12A089773-001MINITRAN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMAL1996-08-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A089773-001MINITRAN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMAL1996-08-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A089773-001MINITRAN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMAL1996-08-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A089773-001MINITRAN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMAL1996-08-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A089773-001MINITRAN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMAL1996-08-303f0d92c62455…
2023-05-13 08:27 UTC2023-05A089773-001MINITRAN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMAL1996-08-30053a50430f4f…
2023-01-26 05:58 UTC2023-01A089773-001MINITRAN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMAL1996-08-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A089773-001MINITRAN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMAL1996-08-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A089773-001MINITRAN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMAL1996-08-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A089773-001MINITRAN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMAL1996-08-30e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A089773-001MINITRAN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMAL1996-08-30cb3db0bc1861…

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
29336-323-302019-10-21C16284748780-1956f9ecf-ce37-621f-e053-dbdaa90a74adfcd4cf8a-e3e6-7da9-6355-c60b7400291a

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
29336-323-30Nitroglycerin Transdermal Delivery System30 in 1 CARTONPATCH303
29336-323-30Nitroglycerin Transdermal Delivery System1 d in 1 PATCHPATCH13

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29336-323NITROGLYCERIN TRANSDERMAL DELIVERY SYSTEM (NITROGLYCERIN) PATCH [GRACEWAY PHARMACEUTICALS, LLC]3Legacy NDC, 2 package rows20091215_fcd4cf8a-e3e6-7da9-6355-c60b7400291a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861657nitroglycerin 0.1 MG/HR 24HR Transdermal SystemPSNfcd4cf8a-e3e6-7da9-6355-c60b7400291a3
486148nitroglycerin 0.2 MG/HR 24HR Transdermal SystemPSNfcd4cf8a-e3e6-7da9-6355-c60b7400291a3
486152nitroglycerin 0.4 MG/HR 24HR Transdermal SystemPSNfcd4cf8a-e3e6-7da9-6355-c60b7400291a3
486146nitroglycerin 0.6 MG/HR 24HR Transdermal SystemPSNfcd4cf8a-e3e6-7da9-6355-c60b7400291a3
86165724 HR nitroglycerin 0.1 MG/HR Transdermal SystemSCDfcd4cf8a-e3e6-7da9-6355-c60b7400291a3
48614824 HR nitroglycerin 0.2 MG/HR Transdermal SystemSCDfcd4cf8a-e3e6-7da9-6355-c60b7400291a3
48615224 HR nitroglycerin 0.4 MG/HR Transdermal SystemSCDfcd4cf8a-e3e6-7da9-6355-c60b7400291a3
48614624 HR nitroglycerin 0.6 MG/HR Transdermal SystemSCDfcd4cf8a-e3e6-7da9-6355-c60b7400291a3
86165724 HR NTG 0.1 MG/HR Transdermal SystemSYfcd4cf8a-e3e6-7da9-6355-c60b7400291a3
48614824 HR NTG 0.2 MG/HR Transdermal SystemSYfcd4cf8a-e3e6-7da9-6355-c60b7400291a3
48615224 HR NTG 0.4 MG/HR Transdermal SystemSYfcd4cf8a-e3e6-7da9-6355-c60b7400291a3
48614624 HR NTG 0.6 MG/HR Transdermal SystemSYfcd4cf8a-e3e6-7da9-6355-c60b7400291a3
86165724 HR TNG 0.1 MG/HR Transdermal SystemSYfcd4cf8a-e3e6-7da9-6355-c60b7400291a3
48614824 HR TNG 0.2 MG/HR Transdermal SystemSYfcd4cf8a-e3e6-7da9-6355-c60b7400291a3
48615224 HR TNG 0.4 MG/HR Transdermal SystemSYfcd4cf8a-e3e6-7da9-6355-c60b7400291a3
48614624 HR TNG 0.6 MG/HR Transdermal SystemSYfcd4cf8a-e3e6-7da9-6355-c60b7400291a3
861657nitroglycerin 0.1 MG/HR 24 HR Transdermal PatchSYfcd4cf8a-e3e6-7da9-6355-c60b7400291a3
861657nitroglycerin 0.1 MG/HR 24HR Transdermal SystemSYfcd4cf8a-e3e6-7da9-6355-c60b7400291a3
486148nitroglycerin 0.2 MG/HR 24HR Transdermal SystemSYfcd4cf8a-e3e6-7da9-6355-c60b7400291a3
486152nitroglycerin 0.4 MG/HR 24HR Transdermal SystemSYfcd4cf8a-e3e6-7da9-6355-c60b7400291a3
486146nitroglycerin 0.6 MG/HR 24HR Transdermal SystemSYfcd4cf8a-e3e6-7da9-6355-c60b7400291a3
486152nitroglycerin 10 MG/Day 24 HR Transdermal PatchSYfcd4cf8a-e3e6-7da9-6355-c60b7400291a3
486146nitroglycerin 14 MG/Day 24 HR Transdermal PatchSYfcd4cf8a-e3e6-7da9-6355-c60b7400291a3
486148nitroglycerin 5 MG/Day 24 HR Transdermal PatchSYfcd4cf8a-e3e6-7da9-6355-c60b7400291a3
861657nitroglycerin 0.1 MG/HR 24HR Transdermal SystemPSN21679c9c-27d7-47c9-828e-b4cc405816cc1
486148nitroglycerin 0.2 MG/HR 24HR Transdermal SystemPSN21679c9c-27d7-47c9-828e-b4cc405816cc1
486152nitroglycerin 0.4 MG/HR 24HR Transdermal SystemPSN21679c9c-27d7-47c9-828e-b4cc405816cc1
86165724 HR nitroglycerin 0.1 MG/HR Transdermal SystemSCD21679c9c-27d7-47c9-828e-b4cc405816cc1
48614824 HR nitroglycerin 0.2 MG/HR Transdermal SystemSCD21679c9c-27d7-47c9-828e-b4cc405816cc1
48615224 HR nitroglycerin 0.4 MG/HR Transdermal SystemSCD21679c9c-27d7-47c9-828e-b4cc405816cc1
86165724 HR NTG 0.1 MG/HR Transdermal SystemSY21679c9c-27d7-47c9-828e-b4cc405816cc1
48614824 HR NTG 0.2 MG/HR Transdermal SystemSY21679c9c-27d7-47c9-828e-b4cc405816cc1
48615224 HR NTG 0.4 MG/HR Transdermal SystemSY21679c9c-27d7-47c9-828e-b4cc405816cc1
86165724 HR TNG 0.1 MG/HR Transdermal SystemSY21679c9c-27d7-47c9-828e-b4cc405816cc1
48614824 HR TNG 0.2 MG/HR Transdermal SystemSY21679c9c-27d7-47c9-828e-b4cc405816cc1
48615224 HR TNG 0.4 MG/HR Transdermal SystemSY21679c9c-27d7-47c9-828e-b4cc405816cc1
861657nitroglycerin 0.1 MG/HR 24 HR Transdermal PatchSY21679c9c-27d7-47c9-828e-b4cc405816cc1
861657nitroglycerin 0.1 MG/HR 24HR Transdermal SystemSY21679c9c-27d7-47c9-828e-b4cc405816cc1
486148nitroglycerin 0.2 MG/HR 24HR Transdermal SystemSY21679c9c-27d7-47c9-828e-b4cc405816cc1
486152nitroglycerin 0.4 MG/HR 24HR Transdermal SystemSY21679c9c-27d7-47c9-828e-b4cc405816cc1
486152nitroglycerin 10 MG/Day 24 HR Transdermal PatchSY21679c9c-27d7-47c9-828e-b4cc405816cc1
486148nitroglycerin 5 MG/Day 24 HR Transdermal PatchSY21679c9c-27d7-47c9-828e-b4cc405816cc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
29336-323-302933603233030 in 1 CARTONHistorical