budesonide

Generic: budesonide

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name budesonide
Generic Name budesonide
Labeler chartwell rx, llc
Dosage Form SUSPENSION
Routes
RESPIRATORY (INHALATION)
Active Ingredients

budesonide .25 mg/2mL

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-822
Product ID 62135-822_10690463-7fb3-af77-e063-6294a90ad2de
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 62135822
Hyphenated Format 62135-822

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
  • 6 POUCH in 1 CARTON (62135-822-84) / 5 AMPULE in 1 POUCH / 2 mL in 1 AMPULE
source: ndc

Packages (1)

62135-822-84 6 POUCH in 1 CARTON (62135-822-84) / 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": "10690463-7fb3-af77-e063-6294a90ad2de", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["Q3OKS62Q6X"], "rxcui": ["349094", "351109"], "spl_set_id": ["374013c9-18c9-4419-b9fb-9bc5c765688e"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 POUCH in 1 CARTON (62135-822-84)  / 5 AMPULE in 1 POUCH / 2 mL in 1 AMPULE", "package_ndc": "62135-822-84", "marketing_start_date": "20240130"}], "brand_name": "Budesonide", "product_id": "62135-822_10690463-7fb3-af77-e063-6294a90ad2de", "dosage_form": "SUSPENSION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "62135-822", "generic_name": "Budesonide", "labeler_name": "Chartwell RX, LLC", "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"}