Ipratropium Bromide

Product NDC
42254-041
11-digit product format
422540041
Labeler code
42254
Product ID
42254-041_95990ec1-9cfd-4b94-afbd-7ced6ecca567
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ipratropium Bromide
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Rebel Distributors Corp
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
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9ccc399f-9de9-4e86-a0ca-d7a2e7c6c36cProduct name220251106
d953267a-4ca0-4d44-91ad-712cdee8ab38Product name220250630
0a278166-c8aa-41b6-b4a5-6ac332bde76aProduct name120230718
6ac73021-459f-435b-b6c5-8c7d6a50c021Product name220170404

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42254-041-252019-09-24C16284748780-19350213a-3bfc-c013-e053-90daa90a1393Ipratropium Bromide Inhalation Solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-041-25Ipratropium Bromide1 in 1 CARTONSOLUTION11
42254-041-25Ipratropium Bromide25 in 1 POUCHSOLUTION251

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-041-25ML - Milliliter42254-041092eb1af-7702-4dd8-9645-d366621d296712012-07-24

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
WATERINACTIVE INGREDIENT059QF0KO0RIPRATROPIUM BROMIDE SOLUTION [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-041IPRATROPIUM BROMIDE SOLUTION [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20120316_95990ec1-9cfd-4b94-afbd-7ced6ecca567.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
836358ipratropium bromide 0.02 % Inhalation SolutionPSN95990ec1-9cfd-4b94-afbd-7ced6ecca5671
836358ipratropium bromide 0.2 MG/ML Inhalation SolutionSCD95990ec1-9cfd-4b94-afbd-7ced6ecca5671
836358ipratropium bromide 0.02 % Inhalation SolutionSY95990ec1-9cfd-4b94-afbd-7ced6ecca5671
836358ipratropium bromide 0.5 MG per 2.5 ML Inhalation SolutionSY95990ec1-9cfd-4b94-afbd-7ced6ecca5671

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42254-041-25422540041251 in 1 CARTONHistorical