FDA.reportPublic FDA data

Ipratropium Bromide

Product NDC
47335-706
11-digit product format
473350706
Labeler code
47335
Product ID
47335-706_147b55d9-c9f9-4a22-814a-acf834a1864d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ipratropium Bromide
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA207903
Marketing category
ANDA
Marketing start
2020-02-04
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
A207903-001IPRATROPIUM BROMIDEIPRATROPIUM BROMIDE0.02%SOLUTION / INHALATION2017-01-03

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 22:54:322026-06A207903-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATION2017-01-03a50c72e98297…

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 BROMIDESun Pharmaceutical Industries, Inc.231ae8f2-1ec9-4e0f-90a8-11d7b62225762022-04-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207903
application number: ANDA207903
ndc (product): 47335-706

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
231ae8f2-1ec9-4e0f-90a8-11d7b6222576Available 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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
0a278166-c8aa-41b6-b4a5-6ac332bde76aProduct name120230718
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
6ac73021-459f-435b-b6c5-8c7d6a50c021Product name220170404
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47335-706-48Ipratropium Bromide2.5 mL in 1 VIALSOLUTION2.55
47335-706-48Ipratropium Bromide5 in 1 POUCHSOLUTION55
47335-706-49Ipratropium Bromide5 in 1 CARTONSOLUTION55
47335-706-52Ipratropium Bromide6 in 1 CARTONSOLUTION65
47335-706-52Ipratropium Bromide5 in 1 POUCHSOLUTION55
47335-706-54Ipratropium Bromide12 in 1 CARTONSOLUTION125
47335-706-54Ipratropium Bromide5 in 1 POUCHSOLUTION55

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47335-706-48ML - Milliliter47335-706a6b0d9f5-a00c-41b1-b5be-4c810d56f04812020-03-10
47335-706-49ML - Milliliter47335-706985a846f-6760-444c-8571-83382317744112020-03-10
47335-706-52ML - Milliliter47335-7068448d47e-a6c5-4315-a8fe-cb9034d9c94412020-03-10
47335-706-54ML - Milliliter47335-706f72cbfe8-f01f-4502-ae28-d24c6cb65f0f12020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47335-706IPRATROPIUM BROMIDE SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.]5Current NDC, Legacy NDC, 7 package rows20220414_231ae8f2-1ec9-4e0f-90a8-11d7b6222576.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
836358ipratropium bromide 0.02 % Inhalation SolutionPSN231ae8f2-1ec9-4e0f-90a8-11d7b62225765
836358ipratropium bromide 0.2 MG/ML Inhalation SolutionSCD231ae8f2-1ec9-4e0f-90a8-11d7b62225765
836358ipratropium bromide 0.02 % Inhalation SolutionSY231ae8f2-1ec9-4e0f-90a8-11d7b62225765
836358ipratropium bromide 0.5 MG per 2.5 ML Inhalation SolutionSY231ae8f2-1ec9-4e0f-90a8-11d7b62225765

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47335-706-48473350706482.5 mL in 1 VIAL2.5 mlHistorical
47335-706-49473350706495 POUCH in 1 CARTON (47335-706-49) / 5 VIAL in 1 POUCH (47335-706-48) / 2.5 mL in 1 VIAL5 pouch2020-02-040000-00-00NoNoCurrent
47335-706-52473350706526 POUCH in 1 CARTON (47335-706-52) / 5 VIAL in 1 POUCH / 2.5 mL in 1 VIAL6 pouch2020-02-040000-00-00NoNoCurrent
47335-706-544733507065412 POUCH in 1 CARTON (47335-706-54) / 5 VIAL in 1 POUCH / 2.5 mL in 1 VIAL12 pouch2020-02-040000-00-00NoNoCurrent