Ipratropium Bromide

Product NDC
68682-399
11-digit product format
686820399
Labeler code
68682
Product ID
68682-399_bc46ff7c-14fd-4c47-a6e0-a87dda078099
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ipratropium Bromide
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Oceanside Pharmaceuticals
Application
ANDA076103
Marketing category
ANDA
Marketing start
2025-06-01
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
68682-399-15Ipratropium Bromide165 in 1 BOTTLE, SPRAYSPRAY, METERED1658
68682-399-15Ipratropium Bromide1 in 1 CARTONSPRAY, METERED18

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797844ipratropium Br 42 MCG/ACTUAT (0.06 % ) Metered Dose Nasal SprayPSNb1a5e41a-9100-41d5-a7d0-2e763ad5efb68
1797844ipratropium bromide 0.042 MG/ACTUAT Metered Dose Nasal SpraySCDb1a5e41a-9100-41d5-a7d0-2e763ad5efb68
1797844ipratropium bromide 0.06 % Metered Dose Nasal SpraySYb1a5e41a-9100-41d5-a7d0-2e763ad5efb68
1797844ipratropium bromide 42 MCG/ACTUAT Metered Dose Nasal SpraySYb1a5e41a-9100-41d5-a7d0-2e763ad5efb68

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68682-399-15686820399151 BOTTLE, SPRAY in 1 CARTON (68682-399-15) / 165 SPRAY, METERED in 1 BOTTLE, SPRAY2025-06-01NoNoCurrent