budesonide

Generic: budesonide

Labeler: actavis pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name budesonide
Generic Name budesonide
Labeler actavis pharma, inc.
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

budesonide 9 mg/1

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 0591-2510
Product ID 0591-2510_5b1c0fe2-b58d-43b4-8784-038653663c44
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205457
Listing Expiration 2026-12-31
Marketing Start 2018-07-05

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 05912510
Hyphenated Format 0591-2510

Supplemental Identifiers

RxCUI
1366550
UPC
0305912510303
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 ANDA205457 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 9 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0591-2510-30)
source: ndc

Packages (1)

0591-2510-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0591-2510-30)

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": "5b1c0fe2-b58d-43b4-8784-038653663c44", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0305912510303"], "unii": ["Q3OKS62Q6X"], "rxcui": ["1366550"], "spl_set_id": ["41d4fd39-81ee-41be-b34d-efb12b3a359d"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0591-2510-30)", "package_ndc": "0591-2510-30", "marketing_start_date": "20180705"}], "brand_name": "Budesonide", "product_id": "0591-2510_5b1c0fe2-b58d-43b4-8784-038653663c44", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "0591-2510", "generic_name": "Budesonide", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Budesonide", "active_ingredients": [{"name": "BUDESONIDE", "strength": "9 mg/1"}], "application_number": "ANDA205457", "marketing_category": "ANDA", "marketing_start_date": "20180705", "listing_expiration_date": "20261231"}