Ipratropium Bromide

Product NDC
42254-355
11-digit product format
422540355
Labeler code
42254
Product ID
42254-355_09ab5bc2-645f-415d-ad76-246385690176
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ipratropium Bromide
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Rebel Distributors Corp
Application
ANDA076103
Marketing category
ANDA
Marketing start
2003-03-31
Marketing end
0000-00-00
Substance
IPRATROPIUM BROMIDE
Active strength
42 ug/1
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
0a278166-c8aa-41b6-b4a5-6ac332bde76aProduct name120230718
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
6ac73021-459f-435b-b6c5-8c7d6a50c021Product name220170404
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42254-355-152019-09-24C16284748780-19350213a-3cc5-c013-e053-90daa90a1393Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-355-15Ipratropium Bromide165 in 1 BOTTLE, SPRAYSPRAY, METERED1651
42254-355-15Ipratropium Bromide1 in 1 CARTONSPRAY, METERED11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-355-15ML - Milliliter42254-355b718a927-7c52-44b6-b7ab-78197cf38abc12013-03-03

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-355IPRATROPIUM BROMIDE SPRAY, METERED [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20130221_09ab5bc2-645f-415d-ad76-246385690176.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797844ipratropium Br 42 MCG/ACTUAT (0.06 % ) Metered Dose Nasal SprayPSN09ab5bc2-645f-415d-ad76-2463856901761
1797844ipratropium bromide 0.042 MG/ACTUAT Metered Dose Nasal SpraySCD09ab5bc2-645f-415d-ad76-2463856901761
1797844ipratropium bromide 0.06 % Metered Dose Nasal SpraySY09ab5bc2-645f-415d-ad76-2463856901761
1797844ipratropium bromide 42 MCG/ACTUAT Metered Dose Nasal SpraySY09ab5bc2-645f-415d-ad76-2463856901761

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42254-355-1542254035515165 in 1 BOTTLE, SPRAYHistorical