uceris

Generic: budesonide

Labeler: santarus inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name uceris
Generic Name budesonide
Labeler santarus inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

budesonide 9 mg/1

Manufacturer
Santarus Inc.

Identifiers & Regulatory

Product NDC 68012-309
Product ID 68012-309_250346dc-e6de-b148-e063-6394a90a1ca3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA203634
Listing Expiration 2026-12-31
Marketing Start 2013-01-14

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 68012309
Hyphenated Format 68012-309

Supplemental Identifiers

RxCUI
1366550 1366556
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 uceris (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
  • 2 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68012-309-01)
  • 2 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68012-309-02)
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68012-309-30)
source: ndc

Packages (3)

68012-309-01 2 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68012-309-01) 68012-309-02 2 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68012-309-02) 68012-309-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68012-309-30)

Ingredients (1)

budesonide (9 mg/1)

Linked Drug Pages (1)

Uceris ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "250346dc-e6de-b148-e063-6394a90a1ca3", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["Q3OKS62Q6X"], "rxcui": ["1366550", "1366556"], "spl_set_id": ["92cbb190-8851-46ed-bfe0-166ca62ef2e9"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Santarus Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68012-309-01)", "package_ndc": "68012-309-01", "marketing_start_date": "20130114"}, {"sample": false, "description": "2 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68012-309-02)", "package_ndc": "68012-309-02", "marketing_start_date": "20130114"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68012-309-30)", "package_ndc": "68012-309-30", "marketing_start_date": "20130114"}], "brand_name": "Uceris", "product_id": "68012-309_250346dc-e6de-b148-e063-6394a90a1ca3", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "68012-309", "generic_name": "budesonide", "labeler_name": "Santarus Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Uceris", "active_ingredients": [{"name": "BUDESONIDE", "strength": "9 mg/1"}], "application_number": "NDA203634", "marketing_category": "NDA", "marketing_start_date": "20130114", "listing_expiration_date": "20261231"}