FDA.reportPublic FDA data

NDC 69238-2016-03 - Ipratropium Bromide

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
69238-2016
Requested NDC
69238-2016-03
Package NDCs from labels
69238-2016-3, 69238-2016-03
Manufacturer
Amneal Pharmaceuticals NY LLC | Amneal Pharmaceuticals, LLC
Effective date
2023-12-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
IPRATROPIUM - Amneal Pharmaceuticals NY LLC | Amneal Pharmaceuticals, LLCAmneal Pharmaceuticals NY LLC | Amneal Pharmaceuticals, LLC2023-12-30HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69238-2016-3Ipratropium Bromide345 in 1 BOTTLE, SPRAYSPRAY34510
69238-2016-3Ipratropium Bromide1 in 1 CARTONSPRAY110

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-2016IPRATROPIUM BROMIDE SPRAY [AMNEAL PHARMACEUTICALS NY LLC]10Current NDC, Legacy NDC, 2 package rows20231231_61820346-29d9-4864-b8f4-4a198b8ac594.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-2016-3ML - Milliliter69238-2016ef06f780-e7d5-4f2d-9a28-2e5220b26e3512022-12-07

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 22 of 113 · 2,248 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ANTIBACTERIALBENZALKONIUM CHLORIDE SOAPTopco Associates LLC463eafac-2367-3e5a-e063-6294a90a62932026-03-09Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Sodium ChlorideSODIUM CHLORIDEHospira, Inc.018a8807-1331-41c3-4889-c7ec502a90432026-03-09Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c7f645-cfb3-6db1-e063-6394a90a42ff2026-03-06WarningsExact identifier
unii: 059QF0KO0R
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: 451W47IQ8X
Loris BZK Antiseptic WipesBENZALKONIUM CHLORIDELernaPharm Loris Inc.a448de7b-4d96-4d53-ae1a-0bd38a2fb4a22026-03-05WarningsExact identifier
unii: F5UM2KM3W7
Hug a BooBoo Medicated booboo WipesBENZOCAINELights Medical Manufacture Co., Ltd.509aaafc-2ef7-4205-818c-7ff5b146e1592026-03-04WarningsExact identifier
unii: F5UM2KM3W7
SSDC Foaming Hand SanitizerBENZALKONIUM CHLORIDEEcolab Inc.c4063012-34ab-4409-baf4-9e3d8f3e20112026-03-04WarningsExact identifier
unii: F5UM2KM3W7
Grain and WheatADRENALINUM, AVENA SATIVA, BRYONIA (ALBA), GLYCINE MAX (SOY), HISTAMINUM HYDROCHLORICUM, BARLEY, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PULSATILLA (PRATENSIS), RYE, WHEAT, CORNNaturalCare3bd8e473-9aac-4a0c-9117-1f1488a75b7b2026-03-03WarningsExact identifier
unii: 451W47IQ8X
Thyroid SupportCALCAREA CARBONICA, CALCAREA IODATA, CAUSTICUM, FERRUM IODATUM, FUCUS VESICULOSUS, KALI IODATUM, NATRUM MURIATICUM, THYROIDINUM (BOVINE)NaturalCare75648609-288c-4988-8b96-46f52d639bd32026-03-03WarningsExact identifier
unii: 451W47IQ8X
SSDC ANTIBACTERIAL FOAM HANDSOAPBENZALKONIUM CHLORIDEEcolab Inc.a2a4e9d1-d63a-476b-a048-d360104e36882026-03-03WarningsExact identifier
unii: F5UM2KM3W7
Benzalkonium chlorideBENZALKONIUM CHLORIDEOld East Main Co.4769b25a-1cc5-5d37-e063-6294a90a6fbb2026-03-02Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Benzalkonium chlorideBENZALKONIUM CHLORIDEOld East Main Co.48e813ce-3893-b95f-e063-6294a90a18f22026-03-02Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Hand WashBENZALKONIUM CHLORIDEOld East Main Co.29e5da06-8897-4a79-8eea-f359ba0bdf782026-03-02Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
AntibacterialBENZALKONIUM CHLORIDEOld East Main Co.3effae93-fd00-4aac-a42f-b5b67123f8512026-03-02Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Moisturizing AntibacterialBENZALKONIUM CHLORIDE 0.13%Old East Main Co.122154ea-bdb3-4e71-bfd5-f1f28d75fb2e2026-03-02Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7
Allergy Relief Indoor and OutdoorALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARUM TRIPHYLLUM, ARUNDO MAURITANICA, EUPHRASIA OFFICINALIS, GALPHIMIA GLAUCA, HISTAMINUM HYDROCHLORICUM, KALI BICHROMICUM, NAPHTHALINUM, NATRUM MURIATICUM, SABADILLA, SOLIDAGO VIRGAUREA, STICTA PULMONARIA, SULPHUR, TRIFOLIUM PRATENSE, AND WYETHIA HELENIOIDES.King Bio Inc.9faa963e-4ddc-461f-95a1-2d10e12606122026-03-02WarningsExact identifier
unii: 451W47IQ8X
LibidotoneARALIA QUINQUEFOLIA, BERBERIS VULGARIS, AGNUS CASTUS, AVENA SATIVA, CAUSTICUM, CONIUM MACULATUM, DAMIANA, GRAPHITES, HYPOPHYSIS SUIS, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SELENIUM METALLICUM, SEPIAEnergique, Inc.4ceacaa0-0219-421a-8fff-c1784c3d0f702026-02-27WarningsExact identifier
unii: 451W47IQ8X
Ipratropium BromideIPRATROPIUM BROMIDENORTHSTAR RX LLCe592b6b5-038a-dbe8-457e-76e88a0f194a2026-02-27Warnings, Adverse reactionsExact identifier
unii: J697UZ2A9J
Ipratropium BromideIPRATROPIUM BROMIDENORTHSTAR RX LLC6493c00f-2306-2cb6-9624-4ea678f665762026-02-27Warnings, Adverse reactionsExact identifier
rxcui: 1797833
unii: J697UZ2A9J
Moisturizing AntibacterialBENZALKONIUM CHLORIDE 0.13%The Kroger Co.c13d327a-5bb2-43fa-bc0b-9199e7fd3a382026-02-27Warnings, Adverse reactionsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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