budesonide

Generic: budesonide

Labeler: padagis us llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name budesonide
Generic Name budesonide
Labeler padagis us llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

budesonide 3 mg/1

Manufacturer
Padagis US LLC

Identifiers & Regulatory

Product NDC 0574-9855
Product ID 0574-9855_d502ff68-2ba4-461c-a739-9012f4f09dec
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021324
Listing Expiration 2027-12-31
Marketing Start 2018-06-29

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 05749855
Hyphenated Format 0574-9855

Supplemental Identifiers

RxCUI
1244214
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 NDA021324 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 3 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0574-9855-10) / 100 CAPSULE in 1 BOTTLE
source: ndc

Packages (1)

0574-9855-10 1 BOTTLE in 1 CARTON (0574-9855-10) / 100 CAPSULE in 1 BOTTLE

Ingredients (1)

budesonide (3 mg/1)

Linked Drug Pages (1)

budesonide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d502ff68-2ba4-461c-a739-9012f4f09dec", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["Q3OKS62Q6X"], "rxcui": ["1244214"], "spl_set_id": ["3a18d5a7-04c5-4137-8155-70a8adc0a48b"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Padagis US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0574-9855-10)  / 100 CAPSULE in 1 BOTTLE", "package_ndc": "0574-9855-10", "marketing_start_date": "20180629"}], "brand_name": "budesonide", "product_id": "0574-9855_d502ff68-2ba4-461c-a739-9012f4f09dec", "dosage_form": "CAPSULE", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "0574-9855", "generic_name": "budesonide", "labeler_name": "Padagis US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "budesonide", "active_ingredients": [{"name": "BUDESONIDE", "strength": "3 mg/1"}], "application_number": "NDA021324", "marketing_category": "NDA", "marketing_start_date": "20180629", "listing_expiration_date": "20271231"}