FDA.reportPublic FDA data

NDC 16252-098 - 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
16252-098
Package NDCs from labels
16252-098-22, 16252-098-33, 16252-098-66, 16252-098-11, 16252-098-13
Manufacturer
Rebel Distributors Corp
Effective date
2010-09-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ipratropium Bromide - Rebel Distributors CorpRebel Distributors Corp2010-09-29HUMAN PRESCRIPTION DRUG LABEL
Ipratropium Bromide - Cobalt Laboratories, Inc.Cobalt Laboratories, Inc.2007-09-14Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16252-098-11Ipratropium Bromide4 in 1 CARTONSOLUTION41
16252-098-11Ipratropium Bromide30 in 1 POUCHSOLUTION301
16252-098-13Ipratropium Bromide30 in 1 POUCHSOLUTION301
16252-098-13Ipratropium Bromide12 in 1 CARTONSOLUTION121
16252-098-22Ipratropium Bromide1 in 1 CARTONSOLUTION11
16252-098-22Ipratropium Bromide25 in 1 POUCHSOLUTION251
16252-098-33Ipratropium Bromide30 in 1 POUCHSOLUTION301
16252-098-33Ipratropium Bromide1 in 1 CARTONSOLUTION11
16252-098-66Ipratropium Bromide30 in 1 POUCHSOLUTION301
16252-098-66Ipratropium Bromide2 in 1 CARTONSOLUTION21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16252-098IPRATROPIUM BROMIDE (IPRATROPIUM BROMIDE) SOLUTION [COBALT LABORATORIES, INC.]1Unmatched20070928_Lf69f100f-c766-490f-9143-5e8e0c8cb7c9.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Ipratropium BromideACTIVE INGREDIENTJ697UZ2A9JIPRATROPIUM BROMIDE SOLUTION [REBEL DISTRIBUTORS CORP]1
IPRATROPIUMACTIVE MOIETYGR88G0I6ULIPRATROPIUM BROMIDE SOLUTION [REBEL DISTRIBUTORS CORP]1
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBIPRATROPIUM BROMIDE SOLUTION [REBEL DISTRIBUTORS CORP]1
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XIPRATROPIUM BROMIDE SOLUTION [REBEL DISTRIBUTORS CORP]1
WaterINACTIVE INGREDIENT059QF0KO0RIPRATROPIUM BROMIDE SOLUTION [REBEL DISTRIBUTORS CORP]1

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 52 of 52 · 1,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERBaxter Healthcare Company210dc9ab-d6ca-4552-ac19-1be17792d2902016-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Corporation2a96096d-43cc-49b7-af53-b53c17f410012014-07-25Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
SODIUM CHLORIDESODIUM CHLORIDEBaxter Healthcare Corporationb3b4b176-41f0-4ca8-90d4-3fba5707564a2014-02-21Exact identifier
unii: 451W47IQ8X
TIS-U-SOLSODIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM SULFATE, SODIUM PHOSPHATE, AND POTASSIUM PHOSPHATEBaxter Healthcare Corporation9da4121f-d62d-4da4-8dfb-0494da16015f2014-02-21Exact identifier
unii: 451W47IQ8X
Ipratropium BromideIPRATROPIUM BROMIDEMylan Pharmaceuticals Inc.f625d3e3-c175-4d9a-99ea-dab410b262f12013-06-24Warnings, Adverse reactionsExact identifier
rxcui: 836358
unii: J697UZ2A9J
RingersSODIUM CHLORIDE, CALCIUM CHLORIDE, POTASSIUM CHLORIDE,Baxter Healthcare Corporatione1953d54-818d-46a6-8532-518ebae6d84e2012-06-13Exact identifier
unii: 451W47IQ8X
Lactated RingersSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDEBaxter Healthcare Corporationf09f80bf-2f8b-4420-865d-aec2d5e5cd4d2012-06-12Exact identifier
unii: 451W47IQ8X
46b4392a-47dd-47b5-9f99-13e4c188faa446b4392a-47dd-47b5-9f99-13e4c188faa42010-09-29Warnings, Adverse reactionsExact identifier
spl id: 46b4392a-47dd-47b5-9f99-13e4c188faa4
spl set id: 46b4392a-47dd-47b5-9f99-13e4c188faa4
88275718-4AF1-7D44-6C44-66CF73AAD6DBf69f100f-c766-490f-9143-5e8e0c8cb7c92007-09-14Warnings, Adverse reactionsExact identifier
spl id: 88275718-4AF1-7D44-6C44-66CF73AAD6DB

Reported adverse events (FAERS/openFDA)#

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