FDA.reportPublic FDA data

Ipratropium Bromide

Product NDC
64980-640
11-digit product format
649800640
Labeler code
64980
Product ID
64980-640_3249a3d2-4951-f09b-e063-6294a90a9f79
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ipratropium Bromide
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA075562
Marketing category
ANDA
Marketing start
2025-04-25
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
A075562-001IPRATROPIUM BROMIDEIPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONAN2001-09-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075562-001AN

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 22:54:322026-06A075562-001IPRATROPIUM BROMIDE0.02%SOLUTION / INHALATIONAN2001-09-27a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A075562-001AN1a50c72e98297…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ipratropium BromideIPRATROPIUM BROMIDERising Pharma Holdings, Inc.3249aea8-a395-f09f-e063-6294a90a2d8b2026-07-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075562
application number: ANDA075562
ndc (product): 64980-640
Ipratropium BromideIPRATROPIUM BROMIDEChartwell RX, LLC1e3d4faa-cf6e-460b-b1e0-fcc8094505fa2025-12-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075562
application number: ANDA075562
Ipratropium BromideIPRATROPIUM BROMIDENephron Pharmaceuticals Corporationdb8095db-d1fd-4099-9fb1-d1ad4e2849762025-04-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075562
application number: ANDA075562

Additional Listing Data#

Finished product
Yes
Brand name base
Ipratropium Bromide
Listing expiration
2027-12-31

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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3249aea8-a395-f09f-e063-6294a90a2d8bAvailable 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
64980-640-02Ipratropium Bromide1 in 1 CARTONSOLUTION11
64980-640-02Ipratropium Bromide25 in 1 POUCHSOLUTION251
64980-640-03Ipratropium Bromide30 in 1 POUCHSOLUTION301
64980-640-03Ipratropium Bromide1 in 1 CARTONSOLUTION11
64980-640-06Ipratropium Bromide2 in 1 CARTONSOLUTION21
64980-640-06Ipratropium Bromide30 in 1 POUCHSOLUTION301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64980-640-02ML - Milliliter64980-640ca416fcf-c848-413f-9b28-6404bbec852212025-06-13
64980-640-03ML - Milliliter64980-640279136fc-c3c9-4ed6-8d8e-b86760a545be12025-06-13
64980-640-06ML - Milliliter64980-640564de6b6-75f0-4c74-ae8a-5ae6d26e9d7112025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64980-640IPRATROPIUM BROMIDE SOLUTION [RISING PHARMA HOLDINGS, INC.]1Current NDC, 6 package rows20250427_3249aea8-a395-f09f-e063-6294a90a2d8b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
836358ipratropium bromide 0.02 % Inhalation SolutionPSN3249aea8-a395-f09f-e063-6294a90a2d8b1
836358ipratropium bromide 0.2 MG/ML Inhalation SolutionSCD3249aea8-a395-f09f-e063-6294a90a2d8b1
836358ipratropium bromide 0.02 % Inhalation SolutionSY3249aea8-a395-f09f-e063-6294a90a2d8b1
836358ipratropium bromide 0.5 MG per 2.5 ML Inhalation SolutionSY3249aea8-a395-f09f-e063-6294a90a2d8b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
64980-640-02649800640021 POUCH in 1 CARTON (64980-640-02) / 25 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSE1 pouch2025-04-25NoNoCurrent
64980-640-03649800640031 POUCH in 1 CARTON (64980-640-03) / 30 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSE1 pouch2025-04-25NoNoCurrent
64980-640-06649800640062 POUCH in 1 CARTON (64980-640-06) / 30 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSE2 pouch2025-04-25NoNoCurrent