ipratropium bromide and albuterol sulfate

Generic: ipratropium bromide and albuterol sulfate

Labeler: proficient rx lp
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 proficient rx lp
Dosage Form SOLUTION
Routes
RESPIRATORY (INHALATION)
Active Ingredients

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

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 71205-051
Product ID 71205-051_eba3cb7b-c393-4fc7-84ae-ee1b0d1ef90d
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 71205051
Hyphenated Format 71205-051

Supplemental Identifiers

RxCUI
1437702
UPC
0371205051051
UNII
021SEF3731 J697UZ2A9J

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
  • 5 POUCH in 1 CARTON (71205-051-05) / 1 VIAL, SINGLE-USE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-USE
  • 15 POUCH in 1 CARTON (71205-051-15) / 1 VIAL, SINGLE-USE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-USE
  • 30 POUCH in 1 CARTON (71205-051-30) / 1 VIAL, SINGLE-USE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (3)

Ingredients (2)

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

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "eba3cb7b-c393-4fc7-84ae-ee1b0d1ef90d", "openfda": {"upc": ["0371205051051"], "unii": ["021SEF3731", "J697UZ2A9J"], "rxcui": ["1437702"], "spl_set_id": ["a1d9d346-91a5-4f5a-82ed-4ebeaf350a06"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "5 POUCH in 1 CARTON (71205-051-05)  / 1 VIAL, SINGLE-USE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-USE", "package_ndc": "71205-051-05", "marketing_start_date": "20240110"}, {"sample": false, "description": "15 POUCH in 1 CARTON (71205-051-15)  / 1 VIAL, SINGLE-USE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-USE", "package_ndc": "71205-051-15", "marketing_start_date": "20190401"}, {"sample": false, "description": "30 POUCH in 1 CARTON (71205-051-30)  / 1 VIAL, SINGLE-USE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-USE", "package_ndc": "71205-051-30", "marketing_start_date": "20180601"}], "brand_name": "Ipratropium Bromide and Albuterol Sulfate", "product_id": "71205-051_eba3cb7b-c393-4fc7-84ae-ee1b0d1ef90d", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "71205-051", "generic_name": "Ipratropium Bromide and Albuterol Sulfate", "labeler_name": "Proficient Rx LP", "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"}