ipratropium bromide and albuterol sulfate

Generic: ipratropium bromide and albuterol sulfate

Labeler: ritedose pharmaceuticals, 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 ritedose pharmaceuticals, llc
Dosage Form SOLUTION
Routes
RESPIRATORY (INHALATION)
Active Ingredients

albuterol sulfate 2.5 mg/3mL, ipratropium bromide .5 mg/3mL

Manufacturer
Ritedose Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 76204-600
Product ID 76204-600_459ba094-3b2f-c16c-e063-6294a90aa828
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202496
Listing Expiration 2026-12-31
Marketing Start 2012-10-15

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 76204600
Hyphenated Format 76204-600

Supplemental Identifiers

RxCUI
1437702
UPC
0376204600125 0376204600057 0376204600309 0376204600019
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 ANDA202496 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/3mL
  • .5 mg/3mL
source: ndc
Packaging
  • 30 POUCH in 1 CARTON (76204-600-01) / 1 AMPULE in 1 POUCH / 3 mL in 1 AMPULE
  • 6 POUCH in 1 CARTON (76204-600-05) / 5 AMPULE in 1 POUCH / 3 mL in 1 AMPULE
  • 12 POUCH in 1 CARTON (76204-600-12) / 5 AMPULE in 1 POUCH / 3 mL in 1 AMPULE
  • 1 POUCH in 1 CARTON (76204-600-30) / 30 AMPULE in 1 POUCH / 3 mL in 1 AMPULE
  • 2 POUCH in 1 CARTON (76204-600-60) / 30 AMPULE in 1 POUCH / 3 mL in 1 AMPULE
source: ndc

Packages (5)

76204-600-01 30 POUCH in 1 CARTON (76204-600-01) / 1 AMPULE in 1 POUCH / 3 mL in 1 AMPULE 76204-600-05 6 POUCH in 1 CARTON (76204-600-05) / 5 AMPULE in 1 POUCH / 3 mL in 1 AMPULE 76204-600-12 12 POUCH in 1 CARTON (76204-600-12) / 5 AMPULE in 1 POUCH / 3 mL in 1 AMPULE 76204-600-30 1 POUCH in 1 CARTON (76204-600-30) / 30 AMPULE in 1 POUCH / 3 mL in 1 AMPULE 76204-600-60 2 POUCH in 1 CARTON (76204-600-60) / 30 AMPULE in 1 POUCH / 3 mL in 1 AMPULE

Ingredients (2)

albuterol sulfate (2.5 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": "459ba094-3b2f-c16c-e063-6294a90aa828", "openfda": {"upc": ["0376204600125", "0376204600057", "0376204600309", "0376204600019"], "unii": ["021SEF3731", "J697UZ2A9J"], "rxcui": ["1437702"], "spl_set_id": ["e0dee492-8bf9-4360-be9b-9d6ee1ecb256"], "manufacturer_name": ["Ritedose Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 CARTON (76204-600-01)  / 1 AMPULE in 1 POUCH / 3 mL in 1 AMPULE", "package_ndc": "76204-600-01", "marketing_start_date": "20121015"}, {"sample": false, "description": "6 POUCH in 1 CARTON (76204-600-05)  / 5 AMPULE in 1 POUCH / 3 mL in 1 AMPULE", "package_ndc": "76204-600-05", "marketing_start_date": "20121015"}, {"sample": false, "description": "12 POUCH in 1 CARTON (76204-600-12)  / 5 AMPULE in 1 POUCH / 3 mL in 1 AMPULE", "package_ndc": "76204-600-12", "marketing_start_date": "20121015"}, {"sample": false, "description": "1 POUCH in 1 CARTON (76204-600-30)  / 30 AMPULE in 1 POUCH / 3 mL in 1 AMPULE", "package_ndc": "76204-600-30", "marketing_start_date": "20121015"}, {"sample": false, "description": "2 POUCH in 1 CARTON (76204-600-60)  / 30 AMPULE in 1 POUCH / 3 mL in 1 AMPULE", "package_ndc": "76204-600-60", "marketing_start_date": "20121015"}], "brand_name": "IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE", "product_id": "76204-600_459ba094-3b2f-c16c-e063-6294a90aa828", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "76204-600", "generic_name": "Ipratropium Bromide and Albuterol Sulfate", "labeler_name": "Ritedose Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE", "active_ingredients": [{"name": "ALBUTEROL SULFATE", "strength": "2.5 mg/3mL"}, {"name": "IPRATROPIUM BROMIDE", "strength": ".5 mg/3mL"}], "application_number": "ANDA202496", "marketing_category": "ANDA", "marketing_start_date": "20121015", "listing_expiration_date": "20261231"}