FDA.reportPublic FDA data

Nitroglycerin

Product NDC
0378-9116
11-digit product format
003789116
Labeler code
0378
Product ID
0378-9116_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
1996-08-30
Substance
NITROGLYCERIN
Active strength
.6 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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NITROGLYCERIN.6 mg/h

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG59M7S0WS3
Rxcui486146, 486148, 486152, 861657

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
0378-9116-16Nitroglycerin14 h in 1 PATCHPATCH149
0378-9116-16Nitroglycerin1 in 1 POUCHPATCH19
0378-9116-93Nitroglycerin30 in 1 CARTONPATCH309

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-9116-16EA - Each0378-911667b764d4-9383-4bfa-a7fd-b6c833fc648b12018-01-12
0378-9116-93EA - Each0378-91168c1b745b-9dd1-47ab-a8eb-3a5c988c83b812012-07-24

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
0378-9116NITROGLYCERIN PATCH [MYLAN PHARMACEUTICALS INC.]9Current NDC, Legacy NDC, 3 package rows20181116_e98a2692-1cb9-4994-98d8-1d8d9ef1a256.zip

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
0378-9116-160037891161614 h in 1 PATCH14 hHistorical
0378-9116-930037891169330 POUCH in 1 CARTON (0378-9116-93) / 1 PATCH in 1 POUCH (0378-9116-16) / 14 h in 1 PATCH30 pouch1996-08-300000-00-00NoNoCurrent