FDA.reportPublic FDA data

Ipratropium bromide

Product NDC
65862-905
11-digit product format
658620905
Labeler code
65862
Product ID
65862-905_08eada61-404a-b5f8-e063-6294a90a74e7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ipratropium bromide
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Aurobindo Pharma Limited
Application
ANDA206543
Marketing category
ANDA
Marketing start
2016-10-27
Substance
IPRATROPIUM BROMIDE
Active strength
.5 mg/2.5mL
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
A206543-001IPRATROPIUM BROMIDEIPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONAN2016-10-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206543-001AN

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 22:54:322026-06A206543-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONAN2016-10-27a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A206543-001AN1a50c72e98297…

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
Ipratropium bromideIPRATROPIUM BROMIDEAurobindo Pharma Limitedff2b6bda-4acd-41fd-8970-458c5265df212023-10-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206543
application number: ANDA206543
ndc (product): 65862-905

Additional Listing Data#

Finished product
Yes
Brand name base
Ipratropium bromide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IPRATROPIUM BROMIDE.5 mg/2.5mL

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
836358Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ff2b6bda-4acd-41fd-8970-458c5265df21Available 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
65862-905-01Ipratropium bromide2.5 mL in 1 VIAL, SINGLE-DOSESOLUTION2.55
65862-905-01Ipratropium bromide1 in 1 POUCHSOLUTION15
65862-905-03Ipratropium bromide30 in 1 CARTONSOLUTION305
65862-905-25Ipratropium bromide25 in 1 POUCHSOLUTION255
65862-905-25Ipratropium bromide1 in 1 CARTONSOLUTION15
65862-905-30Ipratropium bromide1 in 1 CARTONSOLUTION15
65862-905-33Ipratropium bromide30 in 1 POUCHSOLUTION305
65862-905-33Ipratropium bromide2.5 mL in 1 VIAL, SINGLE-DOSESOLUTION2.55
65862-905-60Ipratropium bromide2 in 1 CARTONSOLUTION25
65862-905-60Ipratropium bromide30 in 1 POUCHSOLUTION305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-905-25ML - Milliliter65862-90596adcc8d-04ec-4e80-a441-4ed1c472726612017-05-04
65862-905-30ML - Milliliter65862-9050b31ef44-e5fe-49a4-8431-8eb5ee4c14dc12017-05-04
65862-905-60ML - Milliliter65862-905b27ad6c4-11d3-40ac-86fb-557ee9d02d2012017-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-905IPRATROPIUM BROMIDE SOLUTION [AUROBINDO PHARMA LIMITED]5Current NDC, Legacy NDC, 10 package rows20231031_ff2b6bda-4acd-41fd-8970-458c5265df21.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
836358ipratropium bromide 0.02 % Inhalation SolutionPSNff2b6bda-4acd-41fd-8970-458c5265df215
836358ipratropium bromide 0.2 MG/ML Inhalation SolutionSCDff2b6bda-4acd-41fd-8970-458c5265df215
836358ipratropium bromide 0.02 % Inhalation SolutionSYff2b6bda-4acd-41fd-8970-458c5265df215
836358ipratropium bromide 0.5 MG per 2.5 ML Inhalation SolutionSYff2b6bda-4acd-41fd-8970-458c5265df215

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-905-01658620905012.5 mL in 1 VIAL, SINGLE-DOSE2.5 mlHistorical
65862-905-036586209050330 POUCH in 1 CARTON (65862-905-03) / 1 VIAL, SINGLE-DOSE in 1 POUCH (65862-905-01) / 2.5 mL in 1 VIAL, SINGLE-DOSE30 pouch2016-10-270000-00-00NoNoCurrent
65862-905-25658620905251 POUCH in 1 CARTON (65862-905-25) / 25 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSE1 pouch2016-10-270000-00-00NoNoCurrent
65862-905-30658620905301 POUCH in 1 CARTON (65862-905-30) / 30 VIAL, SINGLE-DOSE in 1 POUCH (65862-905-33) / 2.5 mL in 1 VIAL, SINGLE-DOSE1 pouch2016-10-270000-00-00NoNoCurrent
65862-905-336586209053330 in 1 POUCHHistorical
65862-905-60658620905602 POUCH in 1 CARTON (65862-905-60) / 30 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSE2 pouch2016-10-270000-00-00NoNoCurrent