budesonide

Generic: budesonide

Labeler: cardinal health 107, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name budesonide
Generic Name budesonide
Labeler cardinal health 107, llc
Dosage Form SUSPENSION
Routes
RESPIRATORY (INHALATION)
Active Ingredients

budesonide .5 mg/2mL

Manufacturer
Cardinal Health 107, LLC

Identifiers & Regulatory

Product NDC 55154-4849
Product ID 55154-4849_87c86c64-8108-42d5-9ea9-75a5de0fe163
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077519
Listing Expiration 2026-12-31
Marketing Start 2019-01-11

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 551544849
Hyphenated Format 55154-4849

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 (source: ndc)
Generic Name budesonide (source: ndc)
Application Number ANDA077519 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • .5 mg/2mL
source: ndc
Packaging
  • 5 VIAL, SINGLE-DOSE in 1 BAG (55154-4849-5) / 2 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

55154-4849-5 5 VIAL, SINGLE-DOSE in 1 BAG (55154-4849-5) / 2 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

budesonide (.5 mg/2mL)

Linked Drug Pages (1)

Budesonide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "87c86c64-8108-42d5-9ea9-75a5de0fe163", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["Q3OKS62Q6X"], "rxcui": ["351109"], "spl_set_id": ["3e8a6cf4-4bda-4e22-8653-12635adfb316"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Cardinal Health 107, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "5 VIAL, SINGLE-DOSE in 1 BAG (55154-4849-5)  / 2 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "55154-4849-5", "marketing_start_date": "20190111"}], "brand_name": "Budesonide", "product_id": "55154-4849_87c86c64-8108-42d5-9ea9-75a5de0fe163", "dosage_form": "SUSPENSION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "55154-4849", "generic_name": "Budesonide", "labeler_name": "Cardinal Health 107, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Budesonide", "active_ingredients": [{"name": "BUDESONIDE", "strength": ".5 mg/2mL"}], "application_number": "ANDA077519", "marketing_category": "ANDA", "marketing_start_date": "20190111", "listing_expiration_date": "20261231"}