Ipratropium Bromide

Product NDC
60505-0826
11-digit product format
605050826
Labeler code
60505
Product ID
60505-0826_faac5983-09f0-c143-fefd-e3a8a27e3564
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ipratropium Bromide
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Apotex Corp.
Application
ANDA076156
Marketing category
ANDA
Marketing start
2020-05-26
Substance
IPRATROPIUM BROMIDE
Active strength
21 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 BROMIDE21 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ697UZ2A9J
Rxcui1797833

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
60505-0826-1Ipratropium Bromide345 in 1 BOTTLE, SPRAYSPRAY, METERED34510
60505-0826-1Ipratropium Bromide1 in 1 CARTONSPRAY, METERED110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-0826-1ML - Milliliter60505-08262e0b986e-6204-40c8-a161-0a3adefe028612020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-0826IPRATROPIUM BROMIDE SPRAY, METERED [APOTEX CORP.]9Current NDC, Legacy NDC, 2 package rows20240927_ac641027-929e-694d-80cd-bf770dc51aa6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797833ipratropium Br 21 MCG/ACTUAT (0.03 % ) Metered Dose Nasal SprayPSNac641027-929e-694d-80cd-bf770dc51aa610
1797833ipratropium bromide 0.021 MG/ACTUAT Metered Dose Nasal SpraySCDac641027-929e-694d-80cd-bf770dc51aa610
1797833ipratropium bromide 21 MCG/ACTUAT Metered Dose Nasal SpraySYac641027-929e-694d-80cd-bf770dc51aa610

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-0826-1605050826011 BOTTLE, SPRAY in 1 CARTON (60505-0826-1) / 345 SPRAY, METERED in 1 BOTTLE, SPRAY2020-05-260000-00-00NoNoCurrent