Ipratropium Bromide

Product NDC
60505-0827
11-digit product format
605050827
Labeler code
60505
Product ID
60505-0827_17e9df4b-5dd7-6d1b-d360-d55ad669069d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ipratropium bromide
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Apotex Corp.
Application
ANDA076155
Marketing category
ANDA
Marketing start
2020-05-26
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
60505-0827-1Ipratropium Bromide1 in 1 CARTONSPRAY, METERED19
60505-0827-1Ipratropium Bromide165 in 1 BOTTLE, PUMPSPRAY, METERED1659

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-0827-1ML - Milliliter60505-0827cf51b607-f5d4-4d16-8013-e98ab2a78d4712020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-0827IPRATROPIUM BROMIDE SPRAY, METERED [APOTEX CORP.]8Current NDC, Legacy NDC, 2 package rows20240927_ec4c8c83-0335-544c-271e-4f27c06105ac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797844ipratropium Br 42 MCG/ACTUAT (0.06 % ) Metered Dose Nasal SprayPSNec4c8c83-0335-544c-271e-4f27c06105ac9
1797844ipratropium bromide 0.042 MG/ACTUAT Metered Dose Nasal SpraySCDec4c8c83-0335-544c-271e-4f27c06105ac9
1797844ipratropium bromide 0.06 % Metered Dose Nasal SpraySYec4c8c83-0335-544c-271e-4f27c06105ac9
1797844ipratropium bromide 42 MCG/ACTUAT Metered Dose Nasal SpraySYec4c8c83-0335-544c-271e-4f27c06105ac9
1797844ipratropium Br 42 MCG/ACTUAT (0.06 % ) Metered Dose Nasal SprayPSN411ccc2c-ec30-450d-8704-b63095fd343b5
1797844ipratropium bromide 0.042 MG/ACTUAT Metered Dose Nasal SpraySCD411ccc2c-ec30-450d-8704-b63095fd343b5
1797844ipratropium bromide 0.06 % Metered Dose Nasal SpraySY411ccc2c-ec30-450d-8704-b63095fd343b5
1797844ipratropium bromide 42 MCG/ACTUAT Metered Dose Nasal SpraySY411ccc2c-ec30-450d-8704-b63095fd343b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-0827-1605050827011 BOTTLE, PUMP in 1 CARTON (60505-0827-1) / 165 SPRAY, METERED in 1 BOTTLE, PUMP2020-05-260000-00-00NoNoCurrent