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 13 of 113 · 2,248 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SHREK GREEN APPLE HAND SANITIZING WIPESHAND SANITIZING WIPESZhejiang Bright Care Co., Ltd567cbd30-c709-5f64-e063-6394a90adb922026-06-01WarningsExact identifier
unii: F5UM2KM3W7
SHERK WATERMELON HAND SANITIZER WIPESHAND SANITIZING WIPESZhejiang Bright Care Co., Ltd567dbd8c-3af6-34b4-e063-6394a90a0e232026-06-01WarningsExact identifier
unii: F5UM2KM3W7
Antiseptic WipeBENZALKONIUM CHLORIDEHubei Fanjian Medical Product Co.,Ltdf278cdbc-ab0a-6d6a-e053-2995a90a74af2026-05-28WarningsExact identifier
unii: F5UM2KM3W7
First Aid Antiseptic Pain Relieving CreamBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEHubei Fanjian Medical Product Co.,Ltdf44aa5a9-45e2-b890-e053-2a95a90a421b2026-05-28WarningsExact identifier
unii: F5UM2KM3W7
PlegisolPOTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, AND MAGNESIUM CHLORIDEHospira, Inc.35a174f0-f0d7-4ec7-3f81-d3d572c059cf2026-05-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Crayola ANTIBACTERIAL HAND WIPESBENZALKONIUM CHLORIDEASHTEL STUDIOS INC.49fc687b-cff1-02f1-e063-6394a90a04d02026-05-27WarningsExact identifier
unii: F5UM2KM3W7
Ipratropium BromideIPRATROPIUM BROMIDERedpharm Drug52c63e41-dbbc-d9d7-e063-6294a90a30c92026-05-27Warnings, Adverse reactionsExact identifier
unii: J697UZ2A9J
Antibacterial Lidocaine Wound GelBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDECVS Pharmacy960bfe55-87f6-3e51-e053-2995a90a867d2026-05-27WarningsExact identifier
unii: F5UM2KM3W7
MyMedic Antiseptic ToweletteBENZALKONIUM CHLORIDEChangzhou Maokang Medical Products Co., Ltd52b3ffec-8fe7-be9b-e063-6294a90a06922026-05-26WarningsExact identifier
unii: F5UM2KM3W7
TPN ElectrolytesSODIUM CHLORIDE, CALCIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, AND SODIUM ACETATE ANHYDROUSHospira, Inc.c00817bc-7b62-4abe-0280-e7930eda3f942026-05-25Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
ACTIVE WIPESBENZALKONIUM CHLORIDEHangzhou Yida Technology Co., Ltd.52b0f451-343d-9d4d-e063-6294a90ad5e22026-05-25WarningsExact identifier
unii: F5UM2KM3W7
tazza Alcohol-Free sanitizerBENZALKONIUM CHLORIDETazza Brands East Inc.52642367-431e-ed1a-e063-6294a90a7fbf2026-05-22WarningsExact identifier
unii: F5UM2KM3W7
Ipratropium Bromide and Albuterol SulfateIPRATROPIUM BROMIDE AND ALBUTEROL SULFATEA-S Medication Solutions65504330-6c02-4e30-9f32-51393e06f20c2026-05-22Warnings, Adverse reactionsExact identifier
unii: J697UZ2A9J
Bacteriostatic WaterBACTERIOSTATIC WATERHospira, Inc.87d6e9dc-fe3b-4593-ac9a-d7493d1959c72026-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
SALINE CLEANINGSODIUM CHLORIDEGuangzhou Huanmei Cosmetics Co., Ltd.524f07cc-ddb9-dda5-e063-6394a90ac0a52026-05-21WarningsExact identifier
unii: 451W47IQ8X
GLOBAL CARE GOLD ANTIBACTERIAL HANDBENZALKONIUM CHLORIDEGLOBAL IMPORT SALES LLC30d4fa59-3b4c-a7fc-e063-6294a90aed052026-05-21WarningsExact identifier
unii: F5UM2KM3W7
Giant EagleBENZALKONIUM CHLORIDEGIANT EAGLEd2cbdd6c-79c3-0726-e053-2a95a90a46512026-05-20WarningsExact identifier
unii: F5UM2KM3W7
Benzalkonium ChlorideLIQUID HAND SOAPAMAZON.COM SERVICES LLC1bf99b68-c8a7-d88c-e063-6294a90ad2d22026-05-20WarningsExact identifier
unii: F5UM2KM3W7
HandsoapBENZALKONIUM CHLORIDECVS Pharmacy Inc.e582bdcf-0d8b-39f1-e053-2995a90a01f22026-05-20WarningsExact identifier
unii: F5UM2KM3W7
Hyvee LHSBENZALKONIUM CHLORIDEApollo Health and Beauty Care42f58da5-9b8b-a0f4-e063-6294a90a77d72026-05-20WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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