Ipratropium Bromide

Product NDC
69238-2017
11-digit product format
692382017
Labeler code
69238
Product ID
69238-2017_671db709-62da-467f-bcee-d67bf6f975a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ipratropium Bromide
Dosage form
SPRAY
Route
NASAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA215105
Marketing category
ANDA
Marketing start
2022-08-18
Substance
IPRATROPIUM BROMIDE
Active strength
42 ug/1
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 BROMIDE42 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ697UZ2A9J
Rxcui1797844

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
69238-2017-2Ipratropium Bromide1 in 1 CARTONSPRAY18
69238-2017-2Ipratropium Bromide165 in 1 BOTTLE, SPRAYSPRAY1658

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-2017IPRATROPIUM BROMIDE SPRAY [AMNEAL PHARMACEUTICALS NY LLC]8Current NDC, Legacy NDC, 2 package rows20231231_3bda47b0-0326-49de-83f5-03b9ec6461f1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797844ipratropium Br 42 MCG/ACTUAT (0.06 % ) Metered Dose Nasal SprayPSN3bda47b0-0326-49de-83f5-03b9ec6461f18
1797844ipratropium bromide 0.042 MG/ACTUAT Metered Dose Nasal SpraySCD3bda47b0-0326-49de-83f5-03b9ec6461f18
1797844ipratropium bromide 0.06 % Metered Dose Nasal SpraySY3bda47b0-0326-49de-83f5-03b9ec6461f18
1797844ipratropium bromide 42 MCG/ACTUAT Metered Dose Nasal SpraySY3bda47b0-0326-49de-83f5-03b9ec6461f18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69238-2017-2692382017021 BOTTLE, SPRAY in 1 CARTON (69238-2017-2) / 165 SPRAY in 1 BOTTLE, SPRAY2022-08-180000-00-00NoNoCurrent