FDA.reportPublic FDA data

Ipratropium Bromide

Product NDC
76204-100
11-digit product format
762040100
Labeler code
76204
Product ID
76204-100_459b984d-b299-c7c0-e063-6294a90a3efd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ipratropium Bromide
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Ritedose Pharmaceuticals, LLC
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
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
76204-100-01Ipratropium Bromide30 in 1 CARTONSOLUTION3017
76204-100-01Ipratropium Bromide1 in 1 POUCHSOLUTION117
76204-100-25Ipratropium Bromide1 in 1 CARTONSOLUTION117
76204-100-25Ipratropium Bromide25 in 1 POUCHSOLUTION2517
76204-100-30Ipratropium Bromide30 in 1 POUCHSOLUTION3017
76204-100-30Ipratropium Bromide1 in 1 CARTONSOLUTION117
76204-100-60Ipratropium Bromide2 in 1 CARTONSOLUTION217
76204-100-60Ipratropium Bromide30 in 1 POUCHSOLUTION3017

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76204-100IPRATROPIUM BROMIDE SOLUTION [RITEDOSE PHARMACEUTICALS, LLC]15Current NDC, Legacy NDC, 8 package rows20241219_22479633-624a-4251-ad3c-1dcba5d503fb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
836358ipratropium bromide 0.02 % Inhalation SolutionPSN22479633-624a-4251-ad3c-1dcba5d503fb17
836358ipratropium bromide 0.2 MG/ML Inhalation SolutionSCD22479633-624a-4251-ad3c-1dcba5d503fb17
836358ipratropium bromide 0.02 % Inhalation SolutionSY22479633-624a-4251-ad3c-1dcba5d503fb17
836358ipratropium bromide 0.5 MG per 2.5 ML Inhalation SolutionSY22479633-624a-4251-ad3c-1dcba5d503fb17
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
836358ipratropium bromide 0.02 % Inhalation SolutionPSN52c63e41-dbbc-d9d7-e063-6294a90a30c91
836358ipratropium bromide 0.02 % Inhalation SolutionPSN769febba-671d-476b-b0c8-71489a2f9d201
836358ipratropium bromide 0.2 MG/ML Inhalation SolutionSCD52c63e41-dbbc-d9d7-e063-6294a90a30c91
836358ipratropium bromide 0.2 MG/ML Inhalation SolutionSCD769febba-671d-476b-b0c8-71489a2f9d201
836358ipratropium bromide 0.02 % Inhalation SolutionSY52c63e41-dbbc-d9d7-e063-6294a90a30c91
836358ipratropium bromide 0.02 % Inhalation SolutionSY769febba-671d-476b-b0c8-71489a2f9d201
836358ipratropium bromide 0.5 MG per 2.5 ML Inhalation SolutionSY52c63e41-dbbc-d9d7-e063-6294a90a30c91
836358ipratropium bromide 0.5 MG per 2.5 ML Inhalation SolutionSY769febba-671d-476b-b0c8-71489a2f9d201

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76204-100-017620401000130 POUCH in 1 CARTON (76204-100-01) / 1 AMPULE in 1 POUCH / 2.5 mL in 1 AMPULE30 pouch2011-11-210000-00-00NoNoCurrent
76204-100-25762040100251 POUCH in 1 CARTON (76204-100-25) / 25 AMPULE in 1 POUCH / 2.5 mL in 1 AMPULE1 pouch2011-11-210000-00-00NoNoCurrent
76204-100-30762040100301 POUCH in 1 CARTON (76204-100-30) / 30 AMPULE in 1 POUCH / 2.5 mL in 1 AMPULE1 pouch2011-11-210000-00-00NoNoCurrent
76204-100-60762040100602 POUCH in 1 CARTON (76204-100-60) / 30 AMPULE in 1 POUCH / 2.5 mL in 1 AMPULE2 pouch2011-11-210000-00-00NoNoCurrent