Ipratropium Bromide

Product NDC
63187-188
11-digit product format
631870188
Labeler code
63187
Product ID
63187-188_c9fb97e3-6748-4b7f-a562-6e4950ec3e4f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ipratropium Bromide
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Proficient Rx LP
Application
ANDA075693
Marketing category
ANDA
Marketing start
2011-03-01
Marketing end
0000-00-00
Substance
IPRATROPIUM BROMIDE
Active strength
1 mg/2.5mL
Pharmacologic classes
Anticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IPRATROPIUM BROMIDEACTIVE INGREDIENTJ697UZ2A9JIPRATROPIUM BROMIDE SOLUTION [PROFICIENT RX LP]1
IPRATROPIUMACTIVE MOIETYGR88G0I6ULIPRATROPIUM BROMIDE SOLUTION [PROFICIENT RX LP]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBIPRATROPIUM BROMIDE SOLUTION [PROFICIENT RX LP]1
WATERINACTIVE INGREDIENT059QF0KO0RIPRATROPIUM BROMIDE SOLUTION [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-188IPRATROPIUM BROMIDE SOLUTION [PROFICIENT RX LP]3Legacy NDC20200131_32d09bd1-f31d-4f39-9600-f80b4eff02f1.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-188-25631870188251 POUCH in 1 CARTON (63187-188-25) > 25 VIAL in 1 POUCH > 2.5 mL in 1 VIAL1 pouch2019-01-010000-00-00NoNoCurrent