budesonide

Generic: budesonide

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name budesonide
Generic Name budesonide
Labeler sun pharmaceutical industries, inc.
Dosage Form SUSPENSION
Routes
RESPIRATORY (INHALATION)
Active Ingredients

budesonide .5 mg/2mL

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 47335-632
Product ID 47335-632_bd3a9267-8719-4d38-bcb3-6001792d06c7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211922
Listing Expiration 2026-12-31
Marketing Start 2021-05-01

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 47335632
Hyphenated Format 47335-632

Supplemental Identifiers

RxCUI
252559 349094 351109
UPC
0347335633498
UNII
Q3OKS62Q6X
NUI
N0000175576 N0000175450

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 budesonide (source: ndc)
Generic Name budesonide (source: ndc)
Application Number ANDA211922 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • .5 mg/2mL
source: ndc
Packaging
  • 6 POUCH in 1 CARTON (47335-632-49) / 5 AMPULE in 1 POUCH (47335-632-48) / 2 mL in 1 AMPULE
source: ndc

Packages (1)

47335-632-49 6 POUCH in 1 CARTON (47335-632-49) / 5 AMPULE in 1 POUCH (47335-632-48) / 2 mL in 1 AMPULE

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": "bd3a9267-8719-4d38-bcb3-6001792d06c7", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0347335633498"], "unii": ["Q3OKS62Q6X"], "rxcui": ["252559", "349094", "351109"], "spl_set_id": ["a39fbcfc-3ffd-44bd-b882-01f8e1844213"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 POUCH in 1 CARTON (47335-632-49)  / 5 AMPULE in 1 POUCH (47335-632-48)  / 2 mL in 1 AMPULE", "package_ndc": "47335-632-49", "marketing_start_date": "20210501"}], "brand_name": "Budesonide", "product_id": "47335-632_bd3a9267-8719-4d38-bcb3-6001792d06c7", "dosage_form": "SUSPENSION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "47335-632", "generic_name": "Budesonide", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Budesonide", "active_ingredients": [{"name": "BUDESONIDE", "strength": ".5 mg/2mL"}], "application_number": "ANDA211922", "marketing_category": "ANDA", "marketing_start_date": "20210501", "listing_expiration_date": "20261231"}