budesonide inhalation suspension

Generic: budesonide

Labeler: exelan pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name budesonide inhalation suspension
Generic Name budesonide
Labeler exelan pharmaceuticals, inc.
Dosage Form INHALANT
Routes
ORAL
Active Ingredients

budesonide .5 mg/2mL

Manufacturer
Exelan Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 76282-641
Product ID 76282-641_c53a81a4-fad8-4587-ac13-cc4de968485e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205710
Listing Expiration 2026-12-31
Marketing Start 2019-04-17

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 76282641
Hyphenated Format 76282-641

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 inhalation suspension (source: ndc)
Generic Name budesonide (source: ndc)
Application Number ANDA205710 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/2mL
source: ndc
Packaging
  • 6 POUCH in 1 CARTON (76282-641-38) / 5 AMPULE in 1 POUCH (76282-641-37) / 2 mL in 1 AMPULE
source: ndc

Packages (1)

76282-641-38 6 POUCH in 1 CARTON (76282-641-38) / 5 AMPULE in 1 POUCH (76282-641-37) / 2 mL in 1 AMPULE

Ingredients (1)

budesonide (.5 mg/2mL)

Linked Drug Pages (1)

Budesonide Inhalation Suspension ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c53a81a4-fad8-4587-ac13-cc4de968485e", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["Q3OKS62Q6X"], "rxcui": ["252559", "349094", "351109"], "spl_set_id": ["d9656442-4587-4867-9a8c-5f5b0402936e"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Exelan Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 POUCH in 1 CARTON (76282-641-38)  / 5 AMPULE in 1 POUCH (76282-641-37)  / 2 mL in 1 AMPULE", "package_ndc": "76282-641-38", "marketing_start_date": "20190417"}], "brand_name": "Budesonide Inhalation Suspension", "product_id": "76282-641_c53a81a4-fad8-4587-ac13-cc4de968485e", "dosage_form": "INHALANT", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "76282-641", "generic_name": "Budesonide", "labeler_name": "Exelan Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Budesonide", "brand_name_suffix": "Inhalation Suspension", "active_ingredients": [{"name": "BUDESONIDE", "strength": ".5 mg/2mL"}], "application_number": "ANDA205710", "marketing_category": "ANDA", "marketing_start_date": "20190417", "listing_expiration_date": "20261231"}