FDA.reportPublic FDA data

Ipratropium Bromide

Product NDC
50090-0668
11-digit product format
500900668
Labeler code
50090
Product ID
50090-0668_48b0ebf7-0563-4c63-8708-87c732ef1562
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ipratropium Bromide
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
A-S Medication Solutions
Application
ANDA075693
Marketing category
ANDA
Marketing start
2011-02-01
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-0668-02023-02-07C16284748780-1f386c64a-46fd-0266-e053-dadaa90a7c1aIpratropium Bromide Inhalation Solution 0.02%
50090-0668-02023-01-30C16284748780-1f386c64a-46fd-0266-e053-dadaa90a7c1aIpratropium Bromide Inhalation Solution 0.02%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0668-0Ipratropium Bromide1 in 1 CARTONSOLUTION110
50090-0668-0Ipratropium Bromide25 mL in 1 POUCHSOLUTION2510

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0668-0ML - Milliliter50090-0668f0fd9ba0-a8ce-4340-823c-300bbd40becd12021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0668IPRATROPIUM BROMIDE SOLUTION [A-S MEDICATION SOLUTIONS]10Current NDC, Legacy NDC, 2 package rows20250110_7159cf05-da58-4eb9-9e6d-a7f24eec5f46.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
836358ipratropium bromide 0.02 % Inhalation SolutionPSN7159cf05-da58-4eb9-9e6d-a7f24eec5f4610
836358ipratropium bromide 0.2 MG/ML Inhalation SolutionSCD7159cf05-da58-4eb9-9e6d-a7f24eec5f4610
836358ipratropium bromide 0.02 % Inhalation SolutionSY7159cf05-da58-4eb9-9e6d-a7f24eec5f4610
836358ipratropium bromide 0.5 MG per 2.5 ML Inhalation SolutionSY7159cf05-da58-4eb9-9e6d-a7f24eec5f4610

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0668-0500900668001 POUCH in 1 CARTON (50090-0668-0) / 25 mL in 1 POUCH1 pouch2014-11-280000-00-00NoNoCurrent