FDA.reportPublic FDA data

Atrovent

Product NDC
50090-0961
Requested package NDC
50090-0961-0
11-digit product format
500900961
Labeler code
50090
Product ID
50090-0961_1e4ea42f-ed4a-43d6-9219-31d5d9e2934f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ipratropium bromide
Dosage form
AEROSOL, METERED
Route
RESPIRATORY (INHALATION)
Labeler
A-S Medication Solutions
Application
NDA021527
Marketing category
NDA
Marketing start
2005-05-01
Marketing end
0000-00-00
Substance
IPRATROPIUM BROMIDE
Active strength
17 ug/1
Pharmacologic classes
Anticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-096150090-0961-0IInactivated 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
N021527-001ATROVENT HFAIPRATROPIUM BROMIDE0.021MG/INHAEROSOL, METERED / INHALATIONABRLD, RS2004-11-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N021527-001AB

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N021527-00184744472030-01-17Drug product, Delist requested2015-05-28

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 22:54:322026-06N021527-001ATROVENT HFA0.021MG/INHAEROSOL, METERED / INHALATIONABRLD, RS2004-11-27a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N021527-001AB1a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N021527-00184744472030-01-17Drug product, Delist requested2015-05-28a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Atrovent HFAIPRATROPIUM BROMIDEBoehringer Ingelheim Pharmaceuticals, Inc.170e98ef-5560-4068-be7d-e649068eb8842025-11-05Warnings, Adverse reactionsExact identifier
application applno (NDA): 021527
application number: NDA021527

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-0961-02023-01-30C16284748780-1f386c649-fd7e-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ATROVENT HFA safely and effectively. See full prescribing information for ATROVENT HFA. ATROVENT® HFA (ipratropium bromide HFA) Inhalation Aerosol FOR ORAL INHALATION ONLY Initial U.S. Approval: 2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0961-0AtroventHFA200 in 1 CANISTERAEROSOL, METERED20011
50090-0961-0AtroventHFA1 in 1 CARTONAEROSOL, METERED111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0961-0GM - Gram50090-0961fae3891c-3003-4aa1-b32d-daaa2ae5762f12018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0961ATROVENT HFA (IPRATROPIUM BROMIDE) AEROSOL, METERED [A-S MEDICATION SOLUTIONS]11Legacy NDC, 2 package rows20190225_70c16bb6-fdf8-45bf-8f01-8e33889d17ac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
836368Atrovent HFA 17 MCG/INHAL Metered Dose Inhaler, 200 ActuationsPSN70c16bb6-fdf8-45bf-8f01-8e33889d17ac11
836343ipratropium bromide 17 MCG/INHAL Metered Dose Inhaler, 200 ActuationsPSN70c16bb6-fdf8-45bf-8f01-8e33889d17ac11
836368200 ACTUAT ipratropium bromide 0.017 MG/ACTUAT Metered Dose Inhaler [Atrovent]SBD70c16bb6-fdf8-45bf-8f01-8e33889d17ac11
836343200 ACTUAT ipratropium bromide 0.017 MG/ACTUAT Metered Dose InhalerSCD70c16bb6-fdf8-45bf-8f01-8e33889d17ac11
836368200 ACTUAT Atrovent HFA 0.017 MG/ACTUAT Metered Dose InhalerSY70c16bb6-fdf8-45bf-8f01-8e33889d17ac11
836368Atrovent 0.017 MG/ACTUAT Metered Dose Inhaler, 200 ACTUATSY70c16bb6-fdf8-45bf-8f01-8e33889d17ac11
836368Atrovent HFA 17 MCG per ACTUAT Metered Dose Inhaler, 200 ACTUATSY70c16bb6-fdf8-45bf-8f01-8e33889d17ac11
836343ipratropium bromide 0.017 MG/ACTUAT Metered Dose Inhaler, 200 ACTUATSY70c16bb6-fdf8-45bf-8f01-8e33889d17ac11
836343ipratropium bromide 17 MCG/ACTUAT Metered Dose Inhaler, 200 ACTUATSY70c16bb6-fdf8-45bf-8f01-8e33889d17ac11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0961-0500900961001 CANISTER in 1 CARTON (50090-0961-0) > 200 AEROSOL, METERED in 1 CANISTER1 canister2014-11-280000-00-00NoNoCurrent