budesonide

Generic: budesonide

Labeler: nephron pharmaceuticals corporation
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name budesonide
Generic Name budesonide
Labeler nephron pharmaceuticals corporation
Dosage Form INHALANT
Routes
RESPIRATORY (INHALATION)
Active Ingredients

budesonide .25 mg/2mL

Manufacturer
Nephron Pharmaceuticals Corporation

Identifiers & Regulatory

Product NDC 0487-9601
Product ID 0487-9601_32635b5d-cc62-710c-e063-6294a90a2802
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078202
Listing Expiration 2026-12-31
Marketing Start 2013-10-01

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 04879601
Hyphenated Format 0487-9601

Supplemental Identifiers

RxCUI
349094 351109
UPC
0304879601017 0304879601307
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 ANDA078202 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • .25 mg/2mL
source: ndc
Packaging
  • 6 POUCH in 1 CARTON (0487-9601-01) / 5 AMPULE in 1 POUCH / 2 mL in 1 AMPULE
  • 30 POUCH in 1 CARTON (0487-9601-30) / 1 AMPULE in 1 POUCH / 2 mL in 1 AMPULE
source: ndc

Packages (2)

0487-9601-01 6 POUCH in 1 CARTON (0487-9601-01) / 5 AMPULE in 1 POUCH / 2 mL in 1 AMPULE 0487-9601-30 30 POUCH in 1 CARTON (0487-9601-30) / 1 AMPULE in 1 POUCH / 2 mL in 1 AMPULE

Ingredients (1)

budesonide (.25 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": "32635b5d-cc62-710c-e063-6294a90a2802", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0304879601017", "0304879601307"], "unii": ["Q3OKS62Q6X"], "rxcui": ["349094", "351109"], "spl_set_id": ["f12043df-f9a3-4edb-88f8-dd176c1a141c"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Nephron Pharmaceuticals Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 POUCH in 1 CARTON (0487-9601-01)  / 5 AMPULE in 1 POUCH / 2 mL in 1 AMPULE", "package_ndc": "0487-9601-01", "marketing_start_date": "20131001"}, {"sample": false, "description": "30 POUCH in 1 CARTON (0487-9601-30)  / 1 AMPULE in 1 POUCH / 2 mL in 1 AMPULE", "package_ndc": "0487-9601-30", "marketing_start_date": "20131001"}], "brand_name": "Budesonide", "product_id": "0487-9601_32635b5d-cc62-710c-e063-6294a90a2802", "dosage_form": "INHALANT", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "0487-9601", "generic_name": "BUDESONIDE", "labeler_name": "Nephron Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Budesonide", "active_ingredients": [{"name": "BUDESONIDE", "strength": ".25 mg/2mL"}], "application_number": "ANDA078202", "marketing_category": "ANDA", "marketing_start_date": "20131001", "listing_expiration_date": "20261231"}