IPRATROPIUM BROMIDE

Product NDC
70748-337
11-digit product format
707480337
Labeler code
70748
Product ID
70748-337_9a5c6534-8f64-4e47-bd67-71433f331d0a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
IPRATROPIUM BROMIDE
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA217886
Marketing category
ANDA
Marketing start
2025-07-03
Substance
IPRATROPIUM BROMIDE
Active strength
42 ug/1
Pharmacologic classes
Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
IPRATROPIUM BROMIDE
Listing expiration
2027-12-31

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
70748-337-01IPRATROPIUM BROMIDE1 in 1 CARTONSPRAY, METERED16
70748-337-01IPRATROPIUM BROMIDE165 in 1 BOTTLE, SPRAYSPRAY, METERED1656

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797844ipratropium Br 42 MCG/ACTUAT (0.06 % ) Metered Dose Nasal SprayPSNee0ac556-8a23-4d5c-a5da-881c1fc6a3396
1797844ipratropium bromide 0.042 MG/ACTUAT Metered Dose Nasal SpraySCDee0ac556-8a23-4d5c-a5da-881c1fc6a3396
1797844ipratropium bromide 0.06 % Metered Dose Nasal SpraySYee0ac556-8a23-4d5c-a5da-881c1fc6a3396
1797844ipratropium bromide 42 MCG/ACTUAT Metered Dose Nasal SpraySYee0ac556-8a23-4d5c-a5da-881c1fc6a3396

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70748-337-01707480337011 BOTTLE, SPRAY in 1 CARTON (70748-337-01) / 165 SPRAY, METERED in 1 BOTTLE, SPRAY2025-07-03NoNoCurrent