FDA.reportPublic FDA data

Ipratropium Bromide

Product NDC
21695-911
11-digit product format
216950911
Labeler code
21695
Product ID
21695-911_46b4392a-47dd-47b5-9f99-13e4c188faa4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ipratropium Bromide
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Rebel Distributors Corp
Application
ANDA076291
Marketing category
ANDA
Marketing start
2005-05-09
Marketing end
0000-00-00
Substance
IPRATROPIUM BROMIDE
Active strength
1 mg/2.5mL
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct21695-911IInactivated by FDA2026-07-31
excluded packagepackage21695-91121695-911-25IInactivated by FDA2026-07-31
excluded packagepackage21695-91121695-911-30IInactivated 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
A076291-001IPRATROPIUM BROMIDEIPRATROPIUM BROMIDE0.02%SOLUTION / INHALATION2005-05-09

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 22:54:322026-06A076291-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATION2005-05-09a50c72e98297…

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
21695-911-252019-09-24C16284748780-1934fe258-4878-48b1-e053-8cdaa90a720a46b4392a-47dd-47b5-9f99-13e4c188faa4
21695-911-302019-09-24C16284748780-1934fe258-4878-48b1-e053-8cdaa90a720a46b4392a-47dd-47b5-9f99-13e4c188faa4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-911-25Ipratropium Bromide1 in 1 CARTONSOLUTION11
21695-911-25Ipratropium Bromide25 in 1 POUCHSOLUTION251
21695-911-30Ipratropium Bromide1 in 1 CARTONSOLUTION11
21695-911-30Ipratropium Bromide30 in 1 POUCHSOLUTION301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-911-25ML - Milliliter21695-911c1a01bd3-fceb-428b-92d5-8a9c2184c57012012-07-24
21695-911-30ML - Milliliter21695-911b4a9214b-5983-4c5a-a562-79afc17e275e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Ipratropium BromideACTIVE INGREDIENTJ697UZ2A9JIPRATROPIUM BROMIDE SOLUTION [REBEL DISTRIBUTORS CORP]1
IPRATROPIUMACTIVE MOIETYGR88G0I6ULIPRATROPIUM BROMIDE SOLUTION [REBEL DISTRIBUTORS CORP]1
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBIPRATROPIUM BROMIDE SOLUTION [REBEL DISTRIBUTORS CORP]1
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XIPRATROPIUM BROMIDE SOLUTION [REBEL DISTRIBUTORS CORP]1
WaterINACTIVE INGREDIENT059QF0KO0RIPRATROPIUM BROMIDE SOLUTION [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-911IPRATROPIUM BROMIDE SOLUTION [REBEL DISTRIBUTORS CORP]1Legacy NDC, 4 package rows20101201_46b4392a-47dd-47b5-9f99-13e4c188faa4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
836358ipratropium bromide 0.02 % Inhalation SolutionPSN46b4392a-47dd-47b5-9f99-13e4c188faa41
836358ipratropium bromide 0.2 MG/ML Inhalation SolutionSCD46b4392a-47dd-47b5-9f99-13e4c188faa41
836358ipratropium bromide 0.02 % Inhalation SolutionSY46b4392a-47dd-47b5-9f99-13e4c188faa41
836358ipratropium bromide 0.5 MG per 2.5 ML Inhalation SolutionSY46b4392a-47dd-47b5-9f99-13e4c188faa41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-911-25216950911251 in 1 CARTONHistorical
21695-911-30216950911301 in 1 CARTONHistorical