ipratropium bromide and albuterol sulfate

Generic: ipratropium bromide and albuterol sulfate

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

Drug Facts

Product Profile

Brand Name ipratropium bromide and albuterol sulfate
Generic Name ipratropium bromide and albuterol sulfate
Labeler chartwell rx, llc
Dosage Form SOLUTION
Routes
RESPIRATORY (INHALATION)
Active Ingredients

albuterol sulfate 3 mg/3mL, ipratropium bromide .5 mg/3mL

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-831
Product ID 62135-831_44fdd133-41a7-3c7b-e063-6394a90a65d1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076749
Listing Expiration 2026-12-31
Marketing Start 2007-12-31

Pharmacologic Class

Classes
adrenergic beta2-agonists [moa] anticholinergic [epc] cholinergic antagonists [moa] beta2-adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62135831
Hyphenated Format 62135-831

Supplemental Identifiers

RxCUI
1437702
UPC
0362135831844
UNII
021SEF3731 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 and albuterol sulfate (source: ndc)
Generic Name ipratropium bromide and albuterol sulfate (source: ndc)
Application Number ANDA076749 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 3 mg/3mL
  • .5 mg/3mL
source: ndc
Packaging
  • 6 POUCH in 1 CARTON (62135-831-84) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

62135-831-84 6 POUCH in 1 CARTON (62135-831-84) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE

Ingredients (2)

albuterol sulfate (3 mg/3mL) ipratropium bromide (.5 mg/3mL)

Linked Drug Pages (1)

Ipratropium Bromide and Albuterol Sulfate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "44fdd133-41a7-3c7b-e063-6394a90a65d1", "openfda": {"upc": ["0362135831844"], "unii": ["021SEF3731", "J697UZ2A9J"], "rxcui": ["1437702"], "spl_set_id": ["b444478a-10ce-484f-9039-6383dfb8161e"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 POUCH in 1 CARTON (62135-831-84)  / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "62135-831-84", "marketing_start_date": "20240125"}], "brand_name": "Ipratropium Bromide and Albuterol Sulfate", "product_id": "62135-831_44fdd133-41a7-3c7b-e063-6394a90a65d1", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "62135-831", "generic_name": "Ipratropium Bromide and Albuterol Sulfate", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ipratropium Bromide and Albuterol Sulfate", "active_ingredients": [{"name": "ALBUTEROL SULFATE", "strength": "3 mg/3mL"}, {"name": "IPRATROPIUM BROMIDE", "strength": ".5 mg/3mL"}], "application_number": "ANDA076749", "marketing_category": "ANDA", "marketing_start_date": "20071231", "listing_expiration_date": "20261231"}