budesonide

Generic: budesonide

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name budesonide
Generic Name budesonide
Labeler sandoz inc
Dosage Form SUSPENSION
Routes
RESPIRATORY (INHALATION)
Active Ingredients

budesonide .5 mg/2mL

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 0781-7516
Product ID 0781-7516_89c0a36a-04f4-458f-8518-6a9a92168b2e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201966
Listing Expiration 2026-12-31
Marketing Start 2015-07-24

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 07817516
Hyphenated Format 0781-7516

Supplemental Identifiers

RxCUI
252559 349094 351109
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 ANDA201966 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • .5 mg/2mL
source: ndc
Packaging
  • 6 POUCH in 1 CARTON (0781-7516-87) / 5 AMPULE in 1 POUCH (0781-7516-14) / 2 mL in 1 AMPULE (0781-7516-72)
source: ndc

Packages (1)

0781-7516-87 6 POUCH in 1 CARTON (0781-7516-87) / 5 AMPULE in 1 POUCH (0781-7516-14) / 2 mL in 1 AMPULE (0781-7516-72)

Ingredients (1)

budesonide (.5 mg/2mL)

Linked Drug Pages (1)

Budesonide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "89c0a36a-04f4-458f-8518-6a9a92168b2e", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["Q3OKS62Q6X"], "rxcui": ["252559", "349094", "351109"], "spl_set_id": ["4830c0dd-6964-4108-89bc-3af039612b95"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 POUCH in 1 CARTON (0781-7516-87)  / 5 AMPULE in 1 POUCH (0781-7516-14)  / 2 mL in 1 AMPULE (0781-7516-72)", "package_ndc": "0781-7516-87", "marketing_start_date": "20150724"}], "brand_name": "Budesonide", "product_id": "0781-7516_89c0a36a-04f4-458f-8518-6a9a92168b2e", "dosage_form": "SUSPENSION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "0781-7516", "generic_name": "Budesonide", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Budesonide", "active_ingredients": [{"name": "BUDESONIDE", "strength": ".5 mg/2mL"}], "application_number": "ANDA201966", "marketing_category": "ANDA", "marketing_start_date": "20150724", "listing_expiration_date": "20261231"}