budesonide inhalation

Generic: budesonide inhalation

Labeler: preferred pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name budesonide inhalation
Generic Name budesonide inhalation
Labeler preferred pharmaceuticals, inc.
Dosage Form SUSPENSION
Routes
RESPIRATORY (INHALATION)
Active Ingredients

budesonide .5 mg/2mL

Manufacturer
Preferred Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68788-8503
Product ID 68788-8503_f65d3528-23cd-48fa-82f3-b79564156b58
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210897
Listing Expiration 2026-12-31
Marketing Start 2023-08-09

Pharmacologic Class

Established (EPC)
corticosteroid [epc]
Mechanism of Action
corticosteroid hormone receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687888503
Hyphenated Format 68788-8503

Supplemental Identifiers

RxCUI
351109
UNII
Q3OKS62Q6X
NUI
N0000175576 N0000175450

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 budesonide inhalation (source: ndc)
Generic Name budesonide inhalation (source: ndc)
Application Number ANDA210897 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • .5 mg/2mL
source: ndc
Packaging
  • 6 POUCH in 1 CARTON (68788-8503-3) / 5 AMPULE in 1 POUCH / 2 mL in 1 AMPULE
source: ndc

Packages (1)

68788-8503-3 6 POUCH in 1 CARTON (68788-8503-3) / 5 AMPULE in 1 POUCH / 2 mL in 1 AMPULE

Ingredients (1)

budesonide (.5 mg/2mL)

Linked Drug Pages (1)

budesonide inhalation ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "f65d3528-23cd-48fa-82f3-b79564156b58", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["Q3OKS62Q6X"], "rxcui": ["351109"], "spl_set_id": ["dd74e446-7c1b-4f02-9c73-ba716572ee77"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Preferred Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "6 POUCH in 1 CARTON (68788-8503-3)  / 5 AMPULE in 1 POUCH / 2 mL in 1 AMPULE", "package_ndc": "68788-8503-3", "marketing_start_date": "20230809"}], "brand_name": "budesonide inhalation", "product_id": "68788-8503_f65d3528-23cd-48fa-82f3-b79564156b58", "dosage_form": "SUSPENSION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "68788-8503", "generic_name": "budesonide inhalation", "labeler_name": "Preferred Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "budesonide inhalation", "active_ingredients": [{"name": "BUDESONIDE", "strength": ".5 mg/2mL"}], "application_number": "ANDA210897", "marketing_category": "ANDA", "marketing_start_date": "20230809", "listing_expiration_date": "20261231"}