budesonide

Generic: budesonide

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name budesonide
Generic Name budesonide
Labeler rising pharma holdings, inc.
Dosage Form INHALANT
Routes
RESPIRATORY (INHALATION)
Active Ingredients

budesonide .25 mg/2mL

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 64980-638
Product ID 64980-638_325091e2-1d97-4321-e063-6394a90ae5f9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078202
Listing Expiration 2026-12-31
Marketing Start 2025-03-14

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 64980638
Hyphenated Format 64980-638

Supplemental Identifiers

RxCUI
349094 351109
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
  • 30 POUCH in 1 CARTON (64980-638-03) / 5 AMPULE in 1 POUCH / 2 mL in 1 AMPULE
source: ndc

Packages (1)

64980-638-03 30 POUCH in 1 CARTON (64980-638-03) / 5 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": "325091e2-1d97-4321-e063-6394a90ae5f9", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["Q3OKS62Q6X"], "rxcui": ["349094", "351109"], "spl_set_id": ["3235e2a4-8e12-2d58-e063-6294a90a4936"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 CARTON (64980-638-03)  / 5 AMPULE in 1 POUCH / 2 mL in 1 AMPULE", "package_ndc": "64980-638-03", "marketing_start_date": "20250314"}], "brand_name": "Budesonide", "product_id": "64980-638_325091e2-1d97-4321-e063-6394a90ae5f9", "dosage_form": "INHALANT", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "64980-638", "generic_name": "BUDESONIDE", "labeler_name": "Rising Pharma Holdings, Inc.", "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": "20250314", "listing_expiration_date": "20261231"}