Ipratropium Bromide

Product NDC
62135-830
11-digit product format
621350830
Labeler code
62135
Product ID
62135-830_44fdbe83-0583-3b33-e063-6394a90a66db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ipratropium Bromide
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Chartwell RX, LLC
Application
ANDA075562
Marketing category
ANDA
Marketing start
2001-09-27
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62135-830-84Ipratropium Bromide5 in 1 POUCHSOLUTION53
62135-830-84Ipratropium Bromide6 in 1 CARTONSOLUTION63

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-830-84ML - Milliliter62135-830fdd071ce-bb1a-4215-8fd4-66cc787931c812024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-830IPRATROPIUM BROMIDE SOLUTION [CHARTWELL RX, LLC]2Current NDC, 2 package rows20240131_1e3d4faa-cf6e-460b-b1e0-fcc8094505fa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
836358ipratropium bromide 0.02 % Inhalation SolutionPSN1e3d4faa-cf6e-460b-b1e0-fcc8094505fa3
836358ipratropium bromide 0.2 MG/ML Inhalation SolutionSCD1e3d4faa-cf6e-460b-b1e0-fcc8094505fa3
836358ipratropium bromide 0.02 % Inhalation SolutionSY1e3d4faa-cf6e-460b-b1e0-fcc8094505fa3
836358ipratropium bromide 0.5 MG per 2.5 ML Inhalation SolutionSY1e3d4faa-cf6e-460b-b1e0-fcc8094505fa3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-830-84621350830846 POUCH in 1 CARTON (62135-830-84) / 5 VIAL in 1 POUCH / 2.5 mL in 1 VIAL6 pouch2024-01-25NoNoCurrent