budesonide

Generic: budesonide

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name budesonide
Generic Name budesonide
Labeler bryant ranch prepack
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

budesonide 3 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-8294
Product ID 63629-8294_a249352d-1d2d-4646-8a2b-81a2e37b7e86
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206200
Listing Expiration 2026-12-31
Marketing Start 2017-09-15

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 636298294
Hyphenated Format 63629-8294

Supplemental Identifiers

RxCUI
1244214
UNII
Q3OKS62Q6X
NUI
N0000175576 N0000175450

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 ANDA206200 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 3 mg/1
source: ndc
Packaging
  • 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63629-8294-1)
source: ndc

Packages (1)

63629-8294-1 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63629-8294-1)

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": "a249352d-1d2d-4646-8a2b-81a2e37b7e86", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["Q3OKS62Q6X"], "rxcui": ["1244214"], "spl_set_id": ["4943ef5b-f48b-49d6-b419-467f71ef64e0"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63629-8294-1)", "package_ndc": "63629-8294-1", "marketing_start_date": "20200206"}], "brand_name": "Budesonide", "product_id": "63629-8294_a249352d-1d2d-4646-8a2b-81a2e37b7e86", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "63629-8294", "generic_name": "Budesonide", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Budesonide", "active_ingredients": [{"name": "BUDESONIDE", "strength": "3 mg/1"}], "application_number": "ANDA206200", "marketing_category": "ANDA", "marketing_start_date": "20170915", "listing_expiration_date": "20261231"}