FDA.reportPublic FDA data

Ipratropium Bromide

Product NDC
42254-355
11-digit product format
422540355
Labeler code
42254
Product ID
42254-355_09ab5bc2-645f-415d-ad76-246385690176
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ipratropium Bromide
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Rebel Distributors Corp
Application
ANDA076103
Marketing category
ANDA
Marketing start
2003-03-31
Marketing end
0000-00-00
Substance
IPRATROPIUM BROMIDE
Active strength
42 ug/1
Pharmacologic classes
Anticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct42254-355IInactivated by FDA2026-07-31
excluded packagepackage42254-35542254-355-15IInactivated by FDA2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076103-001IPRATROPIUM BROMIDEIPRATROPIUM BROMIDE0.042MG/SPRAYSPRAY, METERED / NASALAB2003-03-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A076103-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A076103-001IPRATROPIUM BROMIDE0.042MG/SPRAYSPRAY, METERED / NASALAB2003-03-31a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A076103-001AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ipratropium BromideIPRATROPIUM BROMIDEOceanside Pharmaceuticalsb1a5e41a-9100-41d5-a7d0-2e763ad5efb62025-08-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076103
application number: ANDA076103
Ipratropium BromideIPRATROPIUM BROMIDEBausch & Lomb Incorporated3fd850a2-af0f-4291-af5d-52c8d6094e642019-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076103
application number: ANDA076103

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9ccc399f-9de9-4e86-a0ca-d7a2e7c6c36cProduct name220251106
d953267a-4ca0-4d44-91ad-712cdee8ab38Product name220250630
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
0a278166-c8aa-41b6-b4a5-6ac332bde76aProduct name120230718
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
6ac73021-459f-435b-b6c5-8c7d6a50c021Product name220170404
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42254-355-152019-09-24C16284748780-19350213a-3cc5-c013-e053-90daa90a1393Ipratropium Bromide Nasal Solution 0.06% (Nasal Spray)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-355-15Ipratropium Bromide165 in 1 BOTTLE, SPRAYSPRAY, METERED1651
42254-355-15Ipratropium Bromide1 in 1 CARTONSPRAY, METERED11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-355-15ML - Milliliter42254-355b718a927-7c52-44b6-b7ab-78197cf38abc12013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IPRATROPIUM BROMIDEACTIVE INGREDIENTJ697UZ2A9JIPRATROPIUM BROMIDE SPRAY, METERED [REBEL DISTRIBUTORS CORP]1
IPRATROPIUMACTIVE MOIETYGR88G0I6ULIPRATROPIUM BROMIDE SPRAY, METERED [REBEL DISTRIBUTORS CORP]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7IPRATROPIUM BROMIDE SPRAY, METERED [REBEL DISTRIBUTORS CORP]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KIPRATROPIUM BROMIDE SPRAY, METERED [REBEL DISTRIBUTORS CORP]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBIPRATROPIUM BROMIDE SPRAY, METERED [REBEL DISTRIBUTORS CORP]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XIPRATROPIUM BROMIDE SPRAY, METERED [REBEL DISTRIBUTORS CORP]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IIPRATROPIUM BROMIDE SPRAY, METERED [REBEL DISTRIBUTORS CORP]1
WATERINACTIVE INGREDIENT059QF0KO0RIPRATROPIUM BROMIDE SPRAY, METERED [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-355IPRATROPIUM BROMIDE SPRAY, METERED [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20130221_09ab5bc2-645f-415d-ad76-246385690176.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797844ipratropium Br 42 MCG/ACTUAT (0.06 % ) Metered Dose Nasal SprayPSN09ab5bc2-645f-415d-ad76-2463856901761
1797844ipratropium bromide 0.042 MG/ACTUAT Metered Dose Nasal SpraySCD09ab5bc2-645f-415d-ad76-2463856901761
1797844ipratropium bromide 0.06 % Metered Dose Nasal SpraySY09ab5bc2-645f-415d-ad76-2463856901761
1797844ipratropium bromide 42 MCG/ACTUAT Metered Dose Nasal SpraySY09ab5bc2-645f-415d-ad76-2463856901761

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42254-355-1542254035515165 in 1 BOTTLE, SPRAYHistorical