FDA.reportPublic FDA data

Atrovent

Product NDC
0597-0087
11-digit product format
005970087
Labeler code
0597
Product ID
0597-0087_73904f10-4e08-4277-adf6-b605468eb05e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ipratropium bromide
Dosage form
AEROSOL, METERED
Route
RESPIRATORY (INHALATION)
Labeler
Boehringer Ingelheim Pharmaceuticals, Inc.
Application
NDA021527
Marketing category
NDA
Marketing start
2005-05-01
Substance
IPRATROPIUM BROMIDE
Active strength
17 ug/1
Pharmacologic classes
Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
ndc (product): 0597-0087

Additional Listing Data#

Finished product
Yes
Brand name base
Atrovent
Brand name suffix
HFA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IPRATROPIUM BROMIDE17 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
J697UZ2A9JInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
836343Internal RxNorm lookup
836368Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
170e98ef-5560-4068-be7d-e649068eb884Available on FDA.report

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
0597-0087-17AtroventHFA1 in 1 CARTONAEROSOL, METERED121
0597-0087-17AtroventHFA200 in 1 CANISTERAEROSOL, METERED20021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0597-0087-17GM - Gram0597-00871796e96e-2499-49e6-b9dd-99f2bc6d9dfd12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IPRATROPIUM BROMIDEACTIVE INGREDIENTJ697UZ2A9JATROVENT HFA (IPRATROPIUM BROMIDE) AEROSOL, METERED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]13
IPRATROPIUMACTIVE MOIETYGR88G0I6ULATROVENT HFA (IPRATROPIUM BROMIDE) AEROSOL, METERED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]13
IPRATROPIUM BROMIDEACTIVE INGREDIENTJ697UZ2A9JATROVENTHFA (IPRATROPIUM BROMIDE) AEROSOL, METERED [PHYSICIANS TOTAL CARE, INC.]1
IPRATROPIUM BROMIDEACTIVE MOIETYJ697UZ2A9JATROVENTHFA (IPRATROPIUM BROMIDE) AEROSOL, METERED [PHYSICIANS TOTAL CARE, INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MATROVENTHFA (IPRATROPIUM BROMIDE) AEROSOL, METERED [PHYSICIANS TOTAL CARE, INC.]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLATROVENTHFA (IPRATROPIUM BROMIDE) AEROSOL, METERED [PHYSICIANS TOTAL CARE, INC.]1
NORFLURANEINACTIVE INGREDIENTDH9E53K1Y8ATROVENTHFA (IPRATROPIUM BROMIDE) AEROSOL, METERED [PHYSICIANS TOTAL CARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RATROVENTHFA (IPRATROPIUM BROMIDE) AEROSOL, METERED [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0597-0087ATROVENT HFA (IPRATROPIUM BROMIDE) AEROSOL, METERED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]20Current NDC, Legacy NDC, 2 package rows20250112_170e98ef-5560-4068-be7d-e649068eb884.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
836368Atrovent HFA 17 MCG/INHAL Metered Dose Inhaler, 200 ActuationsPSN170e98ef-5560-4068-be7d-e649068eb88421
836343ipratropium bromide 17 MCG/INHAL Metered Dose Inhaler, 200 ActuationsPSN170e98ef-5560-4068-be7d-e649068eb88421
836368200 ACTUAT ipratropium bromide 0.017 MG/ACTUAT Metered Dose Inhaler [Atrovent]SBD170e98ef-5560-4068-be7d-e649068eb88421
836343200 ACTUAT ipratropium bromide 0.017 MG/ACTUAT Metered Dose InhalerSCD170e98ef-5560-4068-be7d-e649068eb88421
836368200 ACTUAT Atrovent HFA 0.017 MG/ACTUAT Metered Dose InhalerSY170e98ef-5560-4068-be7d-e649068eb88421
836368Atrovent 0.017 MG/ACTUAT Metered Dose Inhaler, 200 ACTUATSY170e98ef-5560-4068-be7d-e649068eb88421
836368Atrovent HFA 17 MCG per ACTUAT Metered Dose Inhaler, 200 ACTUATSY170e98ef-5560-4068-be7d-e649068eb88421
836343ipratropium bromide 0.017 MG/ACTUAT Metered Dose Inhaler, 200 ACTUATSY170e98ef-5560-4068-be7d-e649068eb88421
836343ipratropium bromide 17 MCG/ACTUAT Metered Dose Inhaler, 200 ACTUATSY170e98ef-5560-4068-be7d-e649068eb88421
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
836368Atrovent HFA 17 MCG/INHAL Metered Dose Inhaler, 200 ActuationsPSNae462cd6-615b-4f0d-ae6e-59007e7acab05
836343ipratropium bromide 17 MCG/INHAL Metered Dose Inhaler, 200 ActuationsPSNae462cd6-615b-4f0d-ae6e-59007e7acab05
836368200 ACTUAT ipratropium bromide 0.017 MG/ACTUAT Metered Dose Inhaler [Atrovent]SBDae462cd6-615b-4f0d-ae6e-59007e7acab05
836343200 ACTUAT ipratropium bromide 0.017 MG/ACTUAT Metered Dose InhalerSCDae462cd6-615b-4f0d-ae6e-59007e7acab05
836368200 ACTUAT Atrovent HFA 0.017 MG/ACTUAT Metered Dose InhalerSYae462cd6-615b-4f0d-ae6e-59007e7acab05
836368Atrovent 0.017 MG/ACTUAT Metered Dose Inhaler, 200 ACTUATSYae462cd6-615b-4f0d-ae6e-59007e7acab05
836368Atrovent HFA 17 MCG per ACTUAT Metered Dose Inhaler, 200 ACTUATSYae462cd6-615b-4f0d-ae6e-59007e7acab05
836343ipratropium bromide 0.017 MG/ACTUAT Metered Dose Inhaler, 200 ACTUATSYae462cd6-615b-4f0d-ae6e-59007e7acab05
836343ipratropium bromide 17 MCG/ACTUAT Metered Dose Inhaler, 200 ACTUATSYae462cd6-615b-4f0d-ae6e-59007e7acab05
836368Atrovent HFA 17 MCG/INHAL Metered Dose Inhaler, 200 ActuationsPSNb37e86c4-9af4-4278-baa9-d66bb3fb66d61
836343ipratropium bromide 17 MCG/INHAL Metered Dose Inhaler, 200 ActuationsPSNb37e86c4-9af4-4278-baa9-d66bb3fb66d61
836368200 ACTUAT ipratropium bromide 0.017 MG/ACTUAT Metered Dose Inhaler [Atrovent]SBDb37e86c4-9af4-4278-baa9-d66bb3fb66d61
836343200 ACTUAT ipratropium bromide 0.017 MG/ACTUAT Metered Dose InhalerSCDb37e86c4-9af4-4278-baa9-d66bb3fb66d61
836368200 ACTUAT Atrovent HFA 0.017 MG/ACTUAT Metered Dose InhalerSYb37e86c4-9af4-4278-baa9-d66bb3fb66d61
836368Atrovent 0.017 MG/ACTUAT Metered Dose Inhaler, 200 ACTUATSYb37e86c4-9af4-4278-baa9-d66bb3fb66d61
836368Atrovent HFA 17 MCG per ACTUAT Metered Dose Inhaler, 200 ACTUATSYb37e86c4-9af4-4278-baa9-d66bb3fb66d61
836343ipratropium bromide 0.017 MG/ACTUAT Metered Dose Inhaler, 200 ACTUATSYb37e86c4-9af4-4278-baa9-d66bb3fb66d61
836343ipratropium bromide 17 MCG/ACTUAT Metered Dose Inhaler, 200 ACTUATSYb37e86c4-9af4-4278-baa9-d66bb3fb66d61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0597-0087-17005970087171 CANISTER in 1 CARTON (0597-0087-17) / 200 AEROSOL, METERED in 1 CANISTER1 canister2005-05-010000-00-00NoNoCurrent