Nitroglycerin

Product NDC
0378-9102
11-digit product format
003789102
Labeler code
0378
Product ID
0378-9102_68d53366-0e2b-4370-a084-af17a1a88681
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nitroglycerin
Dosage form
PATCH
Route
TRANSDERMAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA074559
Marketing category
ANDA
Marketing start
1998-06-18
Substance
NITROGLYCERIN
Active strength
.1 mg/h
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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074559-001NITROGLYCERINNITROGLYCERIN0.6MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB21996-08-30
A074559-002NITROGLYCERINNITROGLYCERIN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RS1996-08-30
A074559-003NITROGLYCERINNITROGLYCERIN0.2MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB21996-08-30
A074559-004NITROGLYCERINNITROGLYCERIN0.1MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB21998-02-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A074559-001AB2
A074559-002AB2
A074559-003AB2
A074559-004AB2

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 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A074559-001NITROGLYCERIN0.6MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB21996-08-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074559-002NITROGLYCERIN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RS1996-08-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074559-003NITROGLYCERIN0.2MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB21996-08-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074559-004NITROGLYCERIN0.1MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB21998-02-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074559-001NITROGLYCERIN0.6MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RS1996-08-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074559-002NITROGLYCERIN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RS1996-08-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074559-003NITROGLYCERIN0.2MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RS1996-08-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074559-004NITROGLYCERIN0.1MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RS1998-02-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A074559-001NITROGLYCERIN0.6MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RS1996-08-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074559-002NITROGLYCERIN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RS1996-08-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074559-003NITROGLYCERIN0.2MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RS1996-08-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074559-004NITROGLYCERIN0.1MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RS1998-02-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074559-001NITROGLYCERIN0.6MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RS1996-08-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074559-002NITROGLYCERIN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RS1996-08-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074559-003NITROGLYCERIN0.2MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RS1996-08-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074559-004NITROGLYCERIN0.1MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RS1998-02-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074559-001NITROGLYCERIN0.6MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RS1996-08-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074559-002NITROGLYCERIN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RS1996-08-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074559-003NITROGLYCERIN0.2MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RS1996-08-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074559-004NITROGLYCERIN0.1MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RS1998-02-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074559-001NITROGLYCERIN0.6MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RS1996-08-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074559-002NITROGLYCERIN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RS1996-08-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074559-003NITROGLYCERIN0.2MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RS1996-08-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074559-004NITROGLYCERIN0.1MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RS1998-02-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074559-001NITROGLYCERIN0.6MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RS1996-08-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074559-002NITROGLYCERIN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RS1996-08-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074559-003NITROGLYCERIN0.2MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RS1996-08-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074559-004NITROGLYCERIN0.1MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RS1998-02-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074559-001NITROGLYCERIN0.6MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RS1996-08-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074559-002NITROGLYCERIN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RS1996-08-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074559-003NITROGLYCERIN0.2MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RS1996-08-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074559-004NITROGLYCERIN0.1MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RS1998-02-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074559-001NITROGLYCERIN0.6MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RS1996-08-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074559-002NITROGLYCERIN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RS1996-08-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074559-003NITROGLYCERIN0.2MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RS1996-08-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074559-004NITROGLYCERIN0.1MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RS1998-02-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074559-001NITROGLYCERIN0.6MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RS1996-08-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A074559-002NITROGLYCERIN0.4MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RS1996-08-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A074559-003NITROGLYCERIN0.2MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RS1996-08-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A074559-004NITROGLYCERIN0.1MG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2RS1998-02-06d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A074559-001AB21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074559-002AB21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074559-003AB21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074559-004AB21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074559-001AB2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074559-002AB2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074559-003AB2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074559-004AB2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074559-001AB216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074559-002AB216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074559-003AB216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074559-004AB216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074559-001AB21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074559-002AB21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074559-003AB21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074559-004AB21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074559-001AB21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074559-002AB21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074559-003AB21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074559-004AB21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074559-001AB2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074559-002AB2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074559-003AB2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074559-004AB2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074559-001AB212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074559-002AB212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074559-003AB212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074559-004AB212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074559-001AB215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074559-002AB215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074559-003AB215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074559-004AB215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074559-001AB21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074559-002AB21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074559-003AB21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074559-004AB21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074559-001AB21d06236e962d9…
2024-10-29 15:01 UTC2024-10A074559-002AB21d06236e962d9…
2024-10-29 15:01 UTC2024-10A074559-003AB21d06236e962d9…
2024-10-29 15:01 UTC2024-10A074559-004AB21d06236e962d9…

Additional Listing Data#

Finished product
Yes
Brand name base
Nitroglycerin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NITROGLYCERIN.1 mg/h

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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
486146Internal RxNorm lookup
486148Internal RxNorm lookup
486152Internal RxNorm lookup
861657Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e98a2692-1cb9-4994-98d8-1d8d9ef1a256Available 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
0378-9102-16Nitroglycerin1 in 1 POUCHPATCH19
0378-9102-16Nitroglycerin14 h in 1 PATCHPATCH149
0378-9102-93Nitroglycerin30 in 1 CARTONPATCH309

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-9102-16EA - Each0378-910262aec6be-c1bd-4b6d-a855-1554d7c0d4b912018-01-12
0378-9102-93EA - Each0378-910218efabf0-9b4f-4b3b-8af8-8b50f780b75512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NITROGLYCERINACTIVE INGREDIENTG59M7S0WS3NITROGLYCERIN PATCH [MYLAN PHARMACEUTICALS INC.]7
NITROGLYCERINACTIVE MOIETYG59M7S0WS3NITROGLYCERIN PATCH [MYLAN PHARMACEUTICALS INC.]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNITROGLYCERIN PATCH [MYLAN PHARMACEUTICALS INC.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-9102NITROGLYCERIN PATCH [MYLAN PHARMACEUTICALS INC.]9Current NDC, Legacy NDC, 3 package rows20181116_e98a2692-1cb9-4994-98d8-1d8d9ef1a256.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
NitroglycerinNITROGLYCERINMylan Pharmaceuticals Inc.e98a2692-1cb9-4994-98d8-1d8d9ef1a2562014-11-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074559
application number: ANDA074559
ndc (product): 0378-9102

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861657nitroglycerin 0.1 MG/HR 24HR Transdermal SystemPSNe98a2692-1cb9-4994-98d8-1d8d9ef1a2569
486148nitroglycerin 0.2 MG/HR 24HR Transdermal SystemPSNe98a2692-1cb9-4994-98d8-1d8d9ef1a2569
486152nitroglycerin 0.4 MG/HR 24HR Transdermal SystemPSNe98a2692-1cb9-4994-98d8-1d8d9ef1a2569
486146nitroglycerin 0.6 MG/HR 24HR Transdermal SystemPSNe98a2692-1cb9-4994-98d8-1d8d9ef1a2569
86165724 HR nitroglycerin 0.1 MG/HR Transdermal SystemSCDe98a2692-1cb9-4994-98d8-1d8d9ef1a2569
48614824 HR nitroglycerin 0.2 MG/HR Transdermal SystemSCDe98a2692-1cb9-4994-98d8-1d8d9ef1a2569
48615224 HR nitroglycerin 0.4 MG/HR Transdermal SystemSCDe98a2692-1cb9-4994-98d8-1d8d9ef1a2569
48614624 HR nitroglycerin 0.6 MG/HR Transdermal SystemSCDe98a2692-1cb9-4994-98d8-1d8d9ef1a2569
86165724 HR NTG 0.1 MG/HR Transdermal SystemSYe98a2692-1cb9-4994-98d8-1d8d9ef1a2569
48614824 HR NTG 0.2 MG/HR Transdermal SystemSYe98a2692-1cb9-4994-98d8-1d8d9ef1a2569
48615224 HR NTG 0.4 MG/HR Transdermal SystemSYe98a2692-1cb9-4994-98d8-1d8d9ef1a2569
48614624 HR NTG 0.6 MG/HR Transdermal SystemSYe98a2692-1cb9-4994-98d8-1d8d9ef1a2569
86165724 HR TNG 0.1 MG/HR Transdermal SystemSYe98a2692-1cb9-4994-98d8-1d8d9ef1a2569
48614824 HR TNG 0.2 MG/HR Transdermal SystemSYe98a2692-1cb9-4994-98d8-1d8d9ef1a2569
48615224 HR TNG 0.4 MG/HR Transdermal SystemSYe98a2692-1cb9-4994-98d8-1d8d9ef1a2569
48614624 HR TNG 0.6 MG/HR Transdermal SystemSYe98a2692-1cb9-4994-98d8-1d8d9ef1a2569
861657nitroglycerin 0.1 MG/HR 24 HR Transdermal PatchSYe98a2692-1cb9-4994-98d8-1d8d9ef1a2569
861657nitroglycerin 0.1 MG/HR 24HR Transdermal SystemSYe98a2692-1cb9-4994-98d8-1d8d9ef1a2569
486148nitroglycerin 0.2 MG/HR 24HR Transdermal SystemSYe98a2692-1cb9-4994-98d8-1d8d9ef1a2569
486152nitroglycerin 0.4 MG/HR 24HR Transdermal SystemSYe98a2692-1cb9-4994-98d8-1d8d9ef1a2569
486146nitroglycerin 0.6 MG/HR 24HR Transdermal SystemSYe98a2692-1cb9-4994-98d8-1d8d9ef1a2569
486152nitroglycerin 10 MG/Day 24 HR Transdermal PatchSYe98a2692-1cb9-4994-98d8-1d8d9ef1a2569
486146nitroglycerin 14 MG/Day 24 HR Transdermal PatchSYe98a2692-1cb9-4994-98d8-1d8d9ef1a2569
486148nitroglycerin 5 MG/Day 24 HR Transdermal PatchSYe98a2692-1cb9-4994-98d8-1d8d9ef1a2569

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-9102-16003789102161 in 1 POUCHHistorical
0378-9102-930037891029330 POUCH in 1 CARTON (0378-9102-93) / 1 PATCH in 1 POUCH (0378-9102-16) / 14 h in 1 PATCH30 pouch1998-06-180000-00-00NoNoCurrent