FDA.reportPublic FDA data

NDC 0378-9116-16 - Nitroglycerin

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0378-9116
Requested NDC
0378-9116-16
Package NDCs from labels
0378-9116-16, 0378-9116-93
Manufacturer
Mylan Pharmaceuticals Inc.
Effective date
2014-11-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Nitroglycerin - Mylan Pharmaceuticals Inc.Mylan Pharmaceuticals Inc.2014-11-03HUMAN PRESCRIPTION DRUG LABEL

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 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 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

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 108 · 2,155 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
nitroglycerinNITROGLYCERINMedical Purchasing Solutions, LLC.5b150cd2-fac8-86ce-e063-6294a90a67b92026-09-09Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
RectivNITROGLYCERINAllergan, Inc.603aa9ed-54c4-4a35-ade4-690fa44850e42026-09-08Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
nitroglycerinNITROGLYCERINREMEDYREPACK INC.89da40c1-bab1-422e-b326-8ebcbdbc81f32026-09-03Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
NitroglycerinNITROGLYCERINREMEDYREPACK INC.b8af0974-33ea-4dd5-9ff7-3b61272aeb252026-09-01Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
NITROGLYCERINNITROGLYCERINHF Acquisition Co LLC, DBA HealthFirst9a539019-5f43-1448-e053-2a95a90a3bca2026-08-25Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
unii: 15FIX9V2JP
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP
nitroglycerinNITROGLYCERINRedpharm Drug594b939f-d399-835e-e063-6294a90a44222026-08-18Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30HAMBLIN DERMATOLOGY5942e64c-416e-7525-e063-6394a90a28392026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Protect Tinted Mineral SunscreenBROAD SPECTRUM SPF30Opal Day Spa5943413a-48e1-0bdf-e063-6294a90a2fff2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30MedSpa By Beauty Bar LLC5943ba3d-688e-9e9c-e063-6294a90afa9a2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30CORBY, JR., TERRY L.594443fd-8e27-4ec6-e063-6294a90a3ff02026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DR. SAMRAO'S OFFICE58b2ca35-11ed-d848-e063-6294a90a5b372026-08-11WarningsExact identifier
unii: 15FIX9V2JP
NitroglycerinNITROGLYCERINREMEDYREPACK INC.486f53ce-e3c6-48b0-a6ef-9d08cde387e32026-08-10Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3

Reported adverse events (FAERS/openFDA)#

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