budesonide

Generic: budesonide

Labeler: oceanside pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name budesonide
Generic Name budesonide
Labeler oceanside pharmaceuticals
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

budesonide 9 mg/1

Manufacturer
Oceanside Pharmaceuticals

Identifiers & Regulatory

Product NDC 68682-309
Product ID 68682-309_2553124a-3ed4-365d-e063-6294a90a4224
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA203634
Listing Expiration 2026-12-31
Marketing Start 2018-07-10

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 68682309
Hyphenated Format 68682-309

Supplemental Identifiers

RxCUI
1366550
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 NDA203634 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 9 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68682-309-30)
source: ndc

Packages (1)

68682-309-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68682-309-30)

Ingredients (1)

budesonide (9 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": "2553124a-3ed4-365d-e063-6294a90a4224", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["Q3OKS62Q6X"], "rxcui": ["1366550"], "spl_set_id": ["a12b2e99-c8b3-4d08-9af0-8c4a4376ebf1"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Oceanside Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68682-309-30)", "package_ndc": "68682-309-30", "marketing_start_date": "20180710"}], "brand_name": "budesonide", "product_id": "68682-309_2553124a-3ed4-365d-e063-6294a90a4224", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "68682-309", "generic_name": "budesonide", "labeler_name": "Oceanside Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "budesonide", "active_ingredients": [{"name": "BUDESONIDE", "strength": "9 mg/1"}], "application_number": "NDA203634", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20180710", "listing_expiration_date": "20261231"}