FDA.reportPublic FDA data

Combivent Respimat

Product NDC
0597-0024
11-digit product format
005970024
Labeler code
0597
Product ID
0597-0024_aa423748-811c-4bf7-a67f-b38cf394553f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ipratropium bromide and albuterol
Dosage form
SPRAY, METERED
Route
RESPIRATORY (INHALATION)
Labeler
Boehringer Ingelheim Pharmaceuticals, Inc.
Application
NDA021747
Marketing category
NDA
Marketing start
2012-07-01
Substance
ALBUTEROL SULFATE; IPRATROPIUM BROMIDE
Active strength
100; 20 ug/1; ug/1
Pharmacologic classes
Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], beta2-Adrenergic Agonist [EPC]
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
N021747-001COMBIVENT RESPIMATALBUTEROL SULFATE; IPRATROPIUM BROMIDEEQ 0.1MG BASE/INH;0.02MG/INHSPRAY, METERED / INHALATIONRLD, RS2011-10-07

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N021747-00173963412026-10-10Drug product, Delist requested2011-11-02
N021747-00190279672027-03-31Drug product, Delist requested2015-09-04
N021747-00178372352028-03-13Drug product, Delist requested2011-11-02
N021747-00187333412030-10-16Drug product, Delist requested2015-09-04

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 22:54:322026-06N021747-001COMBIVENT RESPIMATEQ 0.1MG BASE/INH;0.02MG/INHSPRAY, METERED / INHALATIONRLD, RS2011-10-07a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N021747-00173963412026-10-10Drug product, Delist requested2011-11-02a50c72e98297…
2026-08-01 22:54:322026-06N021747-00190279672027-03-31Drug product, Delist requested2015-09-04a50c72e98297…
2026-08-01 22:54:322026-06N021747-00178372352028-03-13Drug product, Delist requested2011-11-02a50c72e98297…
2026-08-01 22:54:322026-06N021747-00187333412030-10-16Drug product, Delist requested2015-09-04a50c72e98297…

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
Combivent RespimatIPRATROPIUM BROMIDE AND ALBUTEROLBoehringer Ingelheim Pharmaceuticals, Inc.9832312e-0310-4ab6-8501-afa976fc7eb22025-12-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 021747
application number: NDA021747
ndc (product): 0597-0024

Additional Listing Data#

Finished product
Yes
Brand name base
Combivent Respimat
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IPRATROPIUM BROMIDE100 ug/1
ALBUTEROL SULFATE20 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
J697UZ2A9JInternal UNII lookup
021SEF3731Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1190220Internal RxNorm lookup
1190225Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9832312e-0310-4ab6-8501-afa976fc7eb2Available 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
26005090-31a1-441d-920b-db3101a55d53Product name320250221
1c39b897-7219-42a1-9f3a-ec86cfd7b04bProduct name320250218
0a278166-c8aa-41b6-b4a5-6ac332bde76aProduct name120230718
c76bcd0f-25eb-471e-b970-1956c95c26c5Product name120230425
36390b75-5438-47d3-af60-732a654e9025Product name220220110
387afa72-0c5a-0d6b-ee2c-60c3506659e8Product name620210518
1b8ea3ec-88bd-98ea-c961-00ae340b5b14Product name220200220
3aa5a017-61e9-0c89-adef-13e7964d22f0Product name320171208
6ac73021-459f-435b-b6c5-8c7d6a50c021Product name220170404
c3c27a99-b8bc-4955-841c-26555f58ee7eProduct name120150421
bc98cf6f-a973-7162-5e30-0e7dd8c56bc3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0597-0024-02Combivent Respimat1 in 1 CARTONSPRAY, METERED118
0597-0024-02Combivent Respimat120 in 1 CARTRIDGESPRAY, METERED12018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0597-0024-02GM - Gram0597-00249f4bd0ea-b4ae-4dcd-ad14-0428ca64e04412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALBUTEROL SULFATEACTIVE INGREDIENT021SEF3731COMBIVENT RESPIMAT (IPRATROPIUM BROMIDE AND ALBUTEROL) SPRAY, METERED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]6
IPRATROPIUM BROMIDEACTIVE INGREDIENTJ697UZ2A9JCOMBIVENT RESPIMAT (IPRATROPIUM BROMIDE AND ALBUTEROL) SPRAY, METERED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]6
ALBUTEROLACTIVE MOIETYQF8SVZ843ECOMBIVENT RESPIMAT (IPRATROPIUM BROMIDE AND ALBUTEROL) SPRAY, METERED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]6
IPRATROPIUMACTIVE MOIETYGR88G0I6ULCOMBIVENT RESPIMAT (IPRATROPIUM BROMIDE AND ALBUTEROL) SPRAY, METERED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0597-0024COMBIVENT RESPIMAT (IPRATROPIUM BROMIDE AND ALBUTEROL) SPRAY, METERED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]17Current NDC, Legacy NDC, 2 package rows20240502_9832312e-0310-4ab6-8501-afa976fc7eb2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1190220albuterol/ipratropium bromide 20/100 MCG/INHAL Metered Dose Inhalation Spray, 120 ActuationsPSN9832312e-0310-4ab6-8501-afa976fc7eb218
1190225Combivent 20/100 MCG/INHAL Metered Dose Inhalation Spray, 120 ActuationsPSN9832312e-0310-4ab6-8501-afa976fc7eb218
1190225120 ACTUAT albuterol 0.1 MG/ACTUAT / ipratropium bromide 0.02 MG/ACTUAT Inhalation Spray [Combivent]SBD9832312e-0310-4ab6-8501-afa976fc7eb218
1190220120 ACTUAT albuterol 0.1 MG/ACTUAT / ipratropium bromide 0.02 MG/ACTUAT Inhalation SpraySCD9832312e-0310-4ab6-8501-afa976fc7eb218
1190225120 ACTUAT Albuterol 0.1 MG/ACTUAT / Ipratropium Bromide 0.02 MG/ACTUAT Metered Dose Inhalation Spray [Combivent]SY9832312e-0310-4ab6-8501-afa976fc7eb218
1190220albuterol 0.1 MG/ACTUAT / ipratropium bromide 0.02 MG/ACTUAT Metered Dose Inhalation Spray, 120 ACTUATSY9832312e-0310-4ab6-8501-afa976fc7eb218
1190225Combivent 20/100 (ipratropium bromide / albuterol) Metered Dose Inhalation Spray, 120 ACTUATSY9832312e-0310-4ab6-8501-afa976fc7eb218

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0597-0024-02005970024021 CARTRIDGE in 1 CARTON (0597-0024-02) / 120 SPRAY, METERED in 1 CARTRIDGE1 cartridge2012-07-010000-00-00NoNoCurrent