ipratropium bromide and albuterol sulfate

Generic: ipratropium bromide and albuterol sulfate

Labeler: aurobindo pharma limited
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 aurobindo pharma limited
Dosage Form SOLUTION
Routes
RESPIRATORY (INHALATION)
Active Ingredients

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

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-906
Product ID 65862-906_08febdad-3a3d-f105-e063-6294a90a0b3b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206532
Listing Expiration 2026-12-31
Marketing Start 2020-07-09

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 65862906
Hyphenated Format 65862-906

Supplemental Identifiers

RxCUI
1437702
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 ANDA206532 (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 (65862-906-03) / 1 VIAL, SINGLE-DOSE in 1 POUCH (65862-906-01) / 3 mL in 1 VIAL, SINGLE-DOSE
  • 6 POUCH in 1 CARTON (65862-906-30) / 5 VIAL, SINGLE-DOSE in 1 POUCH (65862-906-05) / 3 mL in 1 VIAL, SINGLE-DOSE
  • 12 POUCH in 1 CARTON (65862-906-60) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (3)

65862-906-03 30 POUCH in 1 CARTON (65862-906-03) / 1 VIAL, SINGLE-DOSE in 1 POUCH (65862-906-01) / 3 mL in 1 VIAL, SINGLE-DOSE 65862-906-30 6 POUCH in 1 CARTON (65862-906-30) / 5 VIAL, SINGLE-DOSE in 1 POUCH (65862-906-05) / 3 mL in 1 VIAL, SINGLE-DOSE 65862-906-60 12 POUCH in 1 CARTON (65862-906-60) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE

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": "08febdad-3a3d-f105-e063-6294a90a0b3b", "openfda": {"unii": ["021SEF3731", "J697UZ2A9J"], "rxcui": ["1437702"], "spl_set_id": ["370516c4-718f-4a71-bdc8-8822060ccefe"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 CARTON (65862-906-03)  / 1 VIAL, SINGLE-DOSE in 1 POUCH (65862-906-01)  / 3 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "65862-906-03", "marketing_start_date": "20200709"}, {"sample": false, "description": "6 POUCH in 1 CARTON (65862-906-30)  / 5 VIAL, SINGLE-DOSE in 1 POUCH (65862-906-05)  / 3 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "65862-906-30", "marketing_start_date": "20200709"}, {"sample": false, "description": "12 POUCH in 1 CARTON (65862-906-60)  / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "65862-906-60", "marketing_start_date": "20200709"}], "brand_name": "Ipratropium Bromide and Albuterol Sulfate", "product_id": "65862-906_08febdad-3a3d-f105-e063-6294a90a0b3b", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "Anticholinergic [EPC]", "Cholinergic Antagonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "65862-906", "generic_name": "Ipratropium Bromide and Albuterol Sulfate", "labeler_name": "Aurobindo Pharma Limited", "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": "ANDA206532", "marketing_category": "ANDA", "marketing_start_date": "20200709", "listing_expiration_date": "20261231"}