ipratropium bromide

Generic: ipratropium bromide

Labeler: northstar rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ipratropium bromide
Generic Name ipratropium bromide
Labeler northstar rx llc
Dosage Form SPRAY, METERED
Routes
NASAL
Active Ingredients

ipratropium bromide 42 ug/1

Manufacturer
NORTHSTAR RX LLC

Identifiers & Regulatory

Product NDC 16714-527
Product ID 16714-527_1ada81c7-04e0-f9ec-8995-d0aa5c19b678
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076155
Listing Expiration 2027-12-31
Marketing Start 2022-02-22

Pharmacologic Class

Classes
anticholinergic [epc] cholinergic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16714527
Hyphenated Format 16714-527

Supplemental Identifiers

RxCUI
1797844
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 ipratropium bromide (source: ndc)
Generic Name ipratropium bromide (source: ndc)
Application Number ANDA076155 (source: ndc)
Routes
NASAL
source: ndc

Resolved Composition

Strengths
  • 42 ug/1
source: ndc
Packaging
  • 1 BOTTLE, PUMP in 1 CARTON (16714-527-01) / 165 SPRAY, METERED in 1 BOTTLE, PUMP
source: ndc

Packages (1)

16714-527-01 1 BOTTLE, PUMP in 1 CARTON (16714-527-01) / 165 SPRAY, METERED in 1 BOTTLE, PUMP

Ingredients (1)

ipratropium bromide (42 ug/1)

Linked Drug Pages (1)

Ipratropium Bromide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["NASAL"], "spl_id": "1ada81c7-04e0-f9ec-8995-d0aa5c19b678", "openfda": {"unii": ["J697UZ2A9J"], "rxcui": ["1797844"], "spl_set_id": ["e592b6b5-038a-dbe8-457e-76e88a0f194a"], "manufacturer_name": ["NORTHSTAR RX LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (16714-527-01)  / 165 SPRAY, METERED in 1 BOTTLE, PUMP", "package_ndc": "16714-527-01", "marketing_start_date": "20220222"}], "brand_name": "Ipratropium Bromide", "product_id": "16714-527_1ada81c7-04e0-f9ec-8995-d0aa5c19b678", "dosage_form": "SPRAY, METERED", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "16714-527", "generic_name": "ipratropium bromide", "labeler_name": "NORTHSTAR RX LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ipratropium Bromide", "active_ingredients": [{"name": "IPRATROPIUM BROMIDE", "strength": "42 ug/1"}], "application_number": "ANDA076155", "marketing_category": "ANDA", "marketing_start_date": "20220222", "listing_expiration_date": "20271231"}