ipratropium bromide

Generic: ipratropium bromide

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ipratropium bromide
Generic Name ipratropium bromide
Labeler rising pharma holdings, inc.
Dosage Form SOLUTION
Routes
RESPIRATORY (INHALATION)
Active Ingredients

ipratropium bromide .5 mg/2.5mL

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 64980-640
Product ID 64980-640_3249a3d2-4951-f09b-e063-6294a90a9f79
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075562
Listing Expiration 2026-12-31
Marketing Start 2025-04-25

Pharmacologic Class

Classes
anticholinergic [epc] cholinergic antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64980640
Hyphenated Format 64980-640

Supplemental Identifiers

RxCUI
836358
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 ANDA075562 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • .5 mg/2.5mL
source: ndc
Packaging
  • 1 POUCH in 1 CARTON (64980-640-02) / 25 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSE
  • 1 POUCH in 1 CARTON (64980-640-03) / 30 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSE
  • 2 POUCH in 1 CARTON (64980-640-06) / 30 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (3)

64980-640-02 1 POUCH in 1 CARTON (64980-640-02) / 25 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSE 64980-640-03 1 POUCH in 1 CARTON (64980-640-03) / 30 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSE 64980-640-06 2 POUCH in 1 CARTON (64980-640-06) / 30 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

ipratropium bromide (.5 mg/2.5mL)

Linked Drug Pages (1)

Ipratropium Bromide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "3249a3d2-4951-f09b-e063-6294a90a9f79", "openfda": {"unii": ["J697UZ2A9J"], "rxcui": ["836358"], "spl_set_id": ["3249aea8-a395-f09f-e063-6294a90a2d8b"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 POUCH in 1 CARTON (64980-640-02)  / 25 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "64980-640-02", "marketing_start_date": "20250425"}, {"sample": false, "description": "1 POUCH in 1 CARTON (64980-640-03)  / 30 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "64980-640-03", "marketing_start_date": "20250425"}, {"sample": false, "description": "2 POUCH in 1 CARTON (64980-640-06)  / 30 VIAL, SINGLE-DOSE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "64980-640-06", "marketing_start_date": "20250425"}], "brand_name": "Ipratropium Bromide", "product_id": "64980-640_3249a3d2-4951-f09b-e063-6294a90a9f79", "dosage_form": "SOLUTION", "pharm_class": ["Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]"], "product_ndc": "64980-640", "generic_name": "Ipratropium Bromide", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ipratropium Bromide", "active_ingredients": [{"name": "IPRATROPIUM BROMIDE", "strength": ".5 mg/2.5mL"}], "application_number": "ANDA075562", "marketing_category": "ANDA", "marketing_start_date": "20250425", "listing_expiration_date": "20261231"}