budesonide inhalation

Generic: budesonide

Labeler: amneal pharmaceuticals of new york llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name budesonide inhalation
Generic Name budesonide
Labeler amneal pharmaceuticals of new york llc
Dosage Form SUSPENSION
Routes
RESPIRATORY (INHALATION)
Active Ingredients

budesonide .25 mg/2mL

Manufacturer
Amneal Pharmaceuticals of New York LLC

Identifiers & Regulatory

Product NDC 0115-1687
Product ID 0115-1687_dbb6c949-66b1-4f60-ab96-442dd8b4ea19
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078404
Listing Expiration 2027-12-31
Marketing Start 2016-08-04

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 01151687
Hyphenated Format 0115-1687

Supplemental Identifiers

RxCUI
349094 351109
UPC
0301151687745
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 (source: ndc)
Generic Name budesonide (source: ndc)
Application Number ANDA078404 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • .25 mg/2mL
source: ndc
Packaging
  • 6 POUCH in 1 CARTON (0115-1687-74) / 5 VIAL in 1 POUCH (0115-1687-76) / 2 mL in 1 VIAL
source: ndc

Packages (1)

0115-1687-74 6 POUCH in 1 CARTON (0115-1687-74) / 5 VIAL in 1 POUCH (0115-1687-76) / 2 mL in 1 VIAL

Ingredients (1)

budesonide (.25 mg/2mL)

Linked Drug Pages (1)

Budesonide Inhalation ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "dbb6c949-66b1-4f60-ab96-442dd8b4ea19", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0301151687745"], "unii": ["Q3OKS62Q6X"], "rxcui": ["349094", "351109"], "spl_set_id": ["e8ef9489-83a2-4817-b21c-ea3fecd8c8dd"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Amneal Pharmaceuticals of New York LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 POUCH in 1 CARTON (0115-1687-74)  / 5 VIAL in 1 POUCH (0115-1687-76)  / 2 mL in 1 VIAL", "package_ndc": "0115-1687-74", "marketing_start_date": "20160804"}], "brand_name": "Budesonide Inhalation", "product_id": "0115-1687_dbb6c949-66b1-4f60-ab96-442dd8b4ea19", "dosage_form": "SUSPENSION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "0115-1687", "generic_name": "Budesonide", "labeler_name": "Amneal Pharmaceuticals of New York LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Budesonide Inhalation", "active_ingredients": [{"name": "BUDESONIDE", "strength": ".25 mg/2mL"}], "application_number": "ANDA078404", "marketing_category": "ANDA", "marketing_start_date": "20160804", "listing_expiration_date": "20271231"}