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 2 of 10 · 183 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BEE VENOM SKIN FIRMING CreamBEE VENOMGuangzhou Mizi Biotechnology Co., LTD.4ccf576f-b6bb-42ac-e063-6294a90a36522026-03-12WarningsExact identifier
unii: AV092KU4JH
Headache and Migraine ReliefBELLADONNA, BRYONIA, CAPSICUM ANNUUM, GELSEMIUM, GLONOINUM, IGNATIA AMARA, KALI BICHROMICUM, KALI CARBONICUM, LYCOPODIUM, NATRUM MURIATICUM, NICCOLUM METALLICUM, NUX VOMICA, SANGUINARIA, SECALE CORNUTUM, SPIGELIA ANTH AND SULPHUR.King Bio Inc.efbfd58c-f3a6-4734-a37f-9f58fded990a2026-03-06WarningsExact identifier
unii: G59M7S0WS3
NitroglycerinNITROGLYCERINGolden State Medical Supply, Inc.df52ab34-e44c-46f3-8c44-2c1bcb93f28e2026-02-19Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
NitroglycerinNITROGLYCERINA-S Medication Solutions532e30c4-cbda-4450-b0a0-e08601c202fb2026-02-17Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
NITRO-BIDNITROGLYCERINSavage Laboratories a division of Fougera Pharmaceuticals, LLCe464e9bb-48e8-4b9f-9fff-e220cfbac0c52026-01-28Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
Hemorrhoid, Fissure, ProctalgiaSuppositoriesCARBON, MIRABILITE, PEPPERMINT OIL, BORNEOLWU XI ZHONG ZHI WEI NA TECHNOLOGY CO., Ltd.1d40d16a-ee52-463a-e063-6394a90a60772026-01-14WarningsExact identifier
unii: AV092KU4JH
Anal Care GLO packCARBON, MIRABILITE, PEPPERMINT OIL, BORNEOLWU XI ZHONG ZHI WEI NA TECHNOLOGY CO., Ltd.26612dae-21a0-6f12-e063-6394a90afe932026-01-14WarningsExact identifier
unii: AV092KU4JH
Hemorrhoid, Fissure, Proctalgia OintmentsCARBON, MIRABILITE, PEPPERMINT OIL, BORNEOL, GLYCERINWU XI ZHONG ZHI WEI NA TECHNOLOGY CO., Ltd.1efe43d5-a29b-5cb2-e063-6394a90aca662026-01-14WarningsExact identifier
unii: AV092KU4JH
NitroglycerinNITROGLYCERINDr. Reddys Laboratories Incc555f8de-477f-0225-98a2-baf8945bbd632026-01-13Warnings, Adverse reactionsExact identifier
unii: G59M7S0WS3
Menopause ReliefBARIUM CARBONATE, ATROPA BELLADONNA, BLACK COHOSH, NITROGLYCERIN, LACHESIS MUTA VENOM, SILICON DIOXIDEHomeocare Laboratories99b182d5-4102-4b25-85d3-f4be077d753f2026-01-12WarningsExact identifier
unii: G59M7S0WS3
ArtalgiaCARDUUS MARIANUS, ARNICA MONTANA, AGARICUS MUSCARIUS, BARYTA CARBONICA, BELLIS PERENNIS, GLONOINUM, HAMAMELIS VIRGINIANATodd Horton DPMc61841db-5a8f-4d36-93bb-19f6c05dd91e2026-01-12WarningsExact identifier
unii: G59M7S0WS3
Pyrogenium Combination 9239PYROGENIUM COMBINATIONProfessional Complementary Health Formulas8b869987-bfd2-4451-a2a8-ce3a92e201f22026-01-08WarningsExact identifier
unii: L11K75P92J
Cranial Sacral Drops 5003CRANIAL SACRAL DROPSProfessional Complementary Health Formulasbb655e0a-f735-4bec-9903-d98ba09cebf72026-01-08WarningsExact identifier
unii: G59M7S0WS3
Pneumo Drops 5018PNEUMO DROPSProfessional Complementary Health Formulasea6d0286-db1c-48c0-83fd-c18fa8f8629f2026-01-08WarningsExact identifier
unii: L11K75P92J
Rib Cage Pain Drops 2056RIB CAGE PAIN DROPSProfessional Complementary Health Formulasf8051769-9714-4444-b736-04b95af64a9b2026-01-08WarningsExact identifier
unii: L11K75P92J
Arsenicum Combination 9251ARSENICUM COMBINATIONProfessional Complementary Health Formulasc52598b3-7100-4410-a4cb-b3dcacf445d72026-01-08WarningsExact identifier
unii: G59M7S0WS3
Seventh Chakra (Crown) 7307SEVENTH CHAKRA (CROWN)Professional Complementary Health Formulas06a2e818-ce9a-4930-adef-5b9990f1b8a32026-01-08WarningsExact identifier
unii: L11K75P92J
Memory Drops 2043MEMORY DROPSProfessional Complementary Health Formulasa9b8897b-e5a1-4db3-94dd-8012aded6ed72026-01-08WarningsExact identifier
unii: L11K75P92J
Calcarea Phosphorica 8002CALCAREA PHOSPHORICAProfessional Complementary Health Formulas555dd940-ed07-4160-bae3-1b4d320dec662026-01-08WarningsExact identifier
unii: L11K75P92J
Adjustment Disorders Formula 2097ADJUSTMENT DISORDERS FORMULAProfessional Complementary Health Formulas72c37485-2334-4a80-b304-1096df25c62b2026-01-08WarningsExact identifier
unii: G59M7S0WS3

Reported adverse events (FAERS/openFDA)#

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