Ipratropium Bromide

Product NDC
60687-394
11-digit product format
606870394
Labeler code
60687
Product ID
60687-394_1a02e20d-3db7-69da-e063-6294a90aff4b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ipratropium Bromide
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
American Health Packaging
Application
ANDA075693
Marketing category
ANDA
Marketing start
2019-01-07
Substance
IPRATROPIUM BROMIDE
Active strength
.5 mg/2.5mL
Pharmacologic classes
Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ipratropium Bromide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IPRATROPIUM BROMIDE.5 mg/2.5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ697UZ2A9J
Rxcui836358

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60687-394-79Ipratropium Bromide2.5 mL in 1 AMPULESOLUTION2.54
60687-394-79Ipratropium Bromide1 in 1 POUCHSOLUTION14
60687-394-83Ipratropium Bromide30 in 1 CARTONSOLUTION304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-394IPRATROPIUM BROMIDE SOLUTION [AMERICAN HEALTH PACKAGING]4Current NDC, Legacy NDC, 3 package rows20240605_8927f392-4c88-4ac1-a934-c444ecf6b2c8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
836358ipratropium bromide 0.02 % Inhalation SolutionPSN51350fab-a919-4d97-9d0c-d9dc7286244c4
836358ipratropium bromide 0.02 % Inhalation SolutionPSN8927f392-4c88-4ac1-a934-c444ecf6b2c84
836358ipratropium bromide 0.2 MG/ML Inhalation SolutionSCD51350fab-a919-4d97-9d0c-d9dc7286244c4
836358ipratropium bromide 0.2 MG/ML Inhalation SolutionSCD8927f392-4c88-4ac1-a934-c444ecf6b2c84
836358ipratropium bromide 0.02 % Inhalation SolutionSY51350fab-a919-4d97-9d0c-d9dc7286244c4
836358ipratropium bromide 0.02 % Inhalation SolutionSY8927f392-4c88-4ac1-a934-c444ecf6b2c84
836358ipratropium bromide 0.5 MG per 2.5 ML Inhalation SolutionSY51350fab-a919-4d97-9d0c-d9dc7286244c4
836358ipratropium bromide 0.5 MG per 2.5 ML Inhalation SolutionSY8927f392-4c88-4ac1-a934-c444ecf6b2c84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-394-79606870394792.5 mL in 1 AMPULE2.5 mlHistorical
60687-394-836068703948330 POUCH in 1 CARTON (60687-394-83) / 1 AMPULE in 1 POUCH (60687-394-79) / 2.5 mL in 1 AMPULE30 pouch2019-01-070000-00-00NoNoCurrent