ipratroprium bromide

Generic: ipratroprium bromide

Labeler: oceanside pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ipratroprium bromide
Generic Name ipratroprium bromide
Labeler oceanside pharmaceuticals
Dosage Form SPRAY, METERED
Routes
NASAL
Active Ingredients

ipratropium bromide 21 ug/1

Manufacturer
Oceanside Pharmaceuticals

Identifiers & Regulatory

Product NDC 68682-398
Product ID 68682-398_b9d78453-9a78-4777-908f-a46a34f09cb1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076025
Listing Expiration 2026-12-31
Marketing Start 2025-06-01

Pharmacologic Class

Classes
anticholinergic [epc] cholinergic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68682398
Hyphenated Format 68682-398

Supplemental Identifiers

RxCUI
1797833
UNII
J697UZ2A9J

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name ipratroprium bromide (source: ndc)
Generic Name ipratroprium bromide (source: ndc)
Application Number ANDA076025 (source: ndc)
Routes
NASAL
source: ndc

Resolved Composition

Strengths
  • 21 ug/1
source: ndc
Packaging
  • 1 BOTTLE, SPRAY in 1 CARTON (68682-398-30) / 345 SPRAY, METERED in 1 BOTTLE, SPRAY
source: ndc

Packages (1)

68682-398-30 1 BOTTLE, SPRAY in 1 CARTON (68682-398-30) / 345 SPRAY, METERED in 1 BOTTLE, SPRAY

Ingredients (1)

ipratropium bromide (21 ug/1)

Linked Drug Pages (1)

Ipratroprium Bromide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["NASAL"], "spl_id": "b9d78453-9a78-4777-908f-a46a34f09cb1", "openfda": {"unii": ["J697UZ2A9J"], "rxcui": ["1797833"], "spl_set_id": ["40e37c2f-a2c0-419b-8451-1aa0458bc420"], "manufacturer_name": ["Oceanside Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, SPRAY in 1 CARTON (68682-398-30)  / 345 SPRAY, METERED in 1 BOTTLE, SPRAY", "package_ndc": "68682-398-30", "marketing_start_date": "20250601"}], "brand_name": "Ipratroprium Bromide", "product_id": "68682-398_b9d78453-9a78-4777-908f-a46a34f09cb1", "dosage_form": "SPRAY, METERED", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "68682-398", "generic_name": "Ipratroprium Bromide", "labeler_name": "Oceanside Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ipratroprium Bromide", "active_ingredients": [{"name": "IPRATROPIUM BROMIDE", "strength": "21 ug/1"}], "application_number": "ANDA076025", "marketing_category": "ANDA", "marketing_start_date": "20250601", "listing_expiration_date": "20261231"}