FDA.reportPublic FDA data

NDC 70007-400-01 - GONITRO

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
70007-400
Requested NDC
70007-400-01
Package NDCs from labels
70007-400-36, 70007-400-99, 70007-400-96, 70007-400-01, 70007-400-12
Manufacturer
Espero Pharmaceuticals, Inc.
Effective date
2018-06-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
GONITRO - Espero Pharmaceuticals, Inc.Espero Pharmaceuticals, Inc.2018-06-20HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
70007-400-12These highlights do not include all the information needed to use GONITRO safely and effectively. See full prescribing information for GONITRO . GONITRO (nitroglycerin) sublingual powder Initial U.S. Approval: 1981
70007-400-36These highlights do not include all the information needed to use GONITRO safely and effectively. See full prescribing information for GONITRO . GONITRO (nitroglycerin) sublingual powder Initial U.S. Approval: 1981
70007-400-96These highlights do not include all the information needed to use GONITRO safely and effectively. See full prescribing information for GONITRO . GONITRO (nitroglycerin) sublingual powder Initial U.S. Approval: 1981
70007-400-99These highlights do not include all the information needed to use GONITRO safely and effectively. See full prescribing information for GONITRO . GONITRO (nitroglycerin) sublingual powder Initial U.S. Approval: 1981

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70007-400GONITRO (NITROGLYCERIN) POWDER [ESPERO PHARMACEUTICALS, INC.]4Legacy NDC20180803_1418d832-4a6a-45ab-8414-25e23f393abb.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70007-400-01EA - Each70007-400ea2f4bfe-a23c-4eb7-b6cf-0418be4279b812016-10-06
70007-400-36EA - Each70007-40019f02220-a503-4c7d-9b12-37e5f9b7309b12016-10-06

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 3 of 10 · 183 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Calcarea Combination 9214CALCAREA COMBINATIONProfessional Complementary Health Formulas54b605d6-1e58-41b1-865b-1280ed75d4942026-01-08WarningsExact identifier
unii: L11K75P92J
Migraine Drops 2140MIGRAINE DROPSProfessional Complementary Health Formulascdae292a-b331-491d-bb4c-73fc15bfc8642026-01-08WarningsExact identifier
unii: G59M7S0WS3
Headache Drops 2027HEADACHE DROPSProfessional Complementary Health Formulasa7e345fb-c4aa-4b10-8074-9d8c373041422026-01-08WarningsExact identifier
unii: G59M7S0WS3
Bone Stim Liquescence 3005BONE STIM LIQUESCENCEProfessional Complementary Health Formulas6e62dde0-adf2-4cdd-8340-abc6b10db3572026-01-08WarningsExact identifier
unii: L11K75P92J
Hypertension Drops 2132HYPERTENSION DROPSProfessional Complementary Health Formulase85ed590-2e60-48c6-ac37-e3d21e5be1032026-01-08WarningsExact identifier
unii: G59M7S0WS3
Cactus Combination 9213CACTUS COMBINATIONProfessional Complementary Health Formulas83dc0667-1ed6-4b08-95c3-28d2021988cf2026-01-08WarningsExact identifier
unii: G59M7S0WS3
Cell Salt Combination 8013CELL SALT COMBINATIONProfessional Complementary Health Formulasb3a33345-3c3d-4f86-ae4d-757c65fd1ed32026-01-08WarningsExact identifier
unii: L11K75P92J
Lactation Flow Drops 2149LACTATION FLOW DROPSProfessional Complementary Health Formulas66a063c4-aa38-4c8e-b361-ee841165edeb2026-01-08WarningsExact identifier
unii: L11K75P92J
Crataegus Combination 9220CRATAEGUS COMBINATIONProfessional Complementary Health Formulasad44d561-9004-43f1-8271-ef52b715fa662026-01-08WarningsExact identifier
unii: G59M7S0WS3
Angina Drops 2083ANGINA DROPSProfessional Complementary Health Formulas99516597-9f59-4123-bd35-a4a73dd54d2d2026-01-08WarningsExact identifier
unii: G59M7S0WS3
Nocturnal Enuresis Drops 2011NOCTURNAL ENURESIS DROPSProfessional Complementary Health Formulas9cd29086-c9eb-4db1-a219-2a8bae3663d82026-01-08WarningsExact identifier
unii: L11K75P92J
Ledum Combination 9257LEDUM COMBINATIONProfessional Complementary Health Formulas38b89b32-4915-487d-8b2d-250123487b152026-01-08WarningsExact identifier
unii: L11K75P92J
RET Lung 7003RET LUNGProfessional Complementary Health Formulas2ed03832-f226-4b3c-9ee6-5352f8d79fdb2026-01-08WarningsExact identifier
unii: L11K75P92J
Myosotis Combination 9234MYOSOTIS COMBINATIONProfessional Complementary Health Formulas8cc292dc-b959-4d81-8277-03044992fccb2026-01-08WarningsExact identifier
unii: L11K75P92J
Anti-Scar Drops 2084ANTI-SCAR DROPSProfessional Complementary Health Formulasad0e9159-ed68-48aa-a7d1-7ff5c32ec3042026-01-08WarningsExact identifier
unii: L11K75P92J
Fifth Chakra (Throat) 7305FIFTH CHAKRA (THROAT)Professional Complementary Health Formulasb731f708-10a8-451f-8550-1e7302102b962026-01-08WarningsExact identifier
unii: L11K75P92J
Dementia Drops 2117DEMENTIA DROPSProfessional Complementary Health Formulas83aec02b-bc62-49a2-ba35-4ac94f9bfc6e2026-01-08WarningsExact identifier
unii: L11K75P92J
NitroglycerinNITROGLYCERINAdvagen Pharma Ltd5a36dac2-7d35-4cbf-be3d-705b7135754d2026-01-07Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
NitroglycerinNITROGLYCERINGlenmark Pharmaceuticals Inc., USAfa789d65-9407-4965-bd06-4457444b42be2025-12-26Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
NitroglycerinNITROGLYCERINSolaris Pharma Corporationf0a76edb-9e63-4aa4-9362-7375c799b2b52025-12-22Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3

Reported adverse events (FAERS/openFDA)#

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