budesonide

Generic: budesonide

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

Drug Facts

Product Profile

Brand Name budesonide
Generic Name budesonide
Labeler teva pharmaceuticals usa, inc.
Dosage Form SUSPENSION
Routes
RESPIRATORY (INHALATION)
Active Ingredients

budesonide .25 mg/2mL

Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0093-6815
Product ID 0093-6815_551a929a-3517-4e58-9df6-f9bfb0f2f3be
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077519
Listing Expiration 2026-12-31
Marketing Start 2019-01-11

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 00936815
Hyphenated Format 0093-6815

Supplemental Identifiers

RxCUI
349094 351109
UPC
0300936816554 0300936815557
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 ANDA077519 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • .25 mg/2mL
source: ndc
Packaging
  • 30 POUCH in 1 CARTON (0093-6815-55) / 1 VIAL, SINGLE-DOSE in 1 POUCH / 2 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

0093-6815-55 30 POUCH in 1 CARTON (0093-6815-55) / 1 VIAL, SINGLE-DOSE in 1 POUCH / 2 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

budesonide (.25 mg/2mL)

Linked Drug Pages (2)

Budesonide ndc-match (0.9) Budesonide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "551a929a-3517-4e58-9df6-f9bfb0f2f3be", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0300936816554", "0300936815557"], "unii": ["Q3OKS62Q6X"], "rxcui": ["349094", "351109"], "spl_set_id": ["4f126a29-38f7-4c4c-8978-37e72b289902"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 CARTON (0093-6815-55)  / 1 VIAL, SINGLE-DOSE in 1 POUCH / 2 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0093-6815-55", "marketing_start_date": "20190111"}], "brand_name": "Budesonide", "product_id": "0093-6815_551a929a-3517-4e58-9df6-f9bfb0f2f3be", "dosage_form": "SUSPENSION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "0093-6815", "generic_name": "Budesonide", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Budesonide", "active_ingredients": [{"name": "BUDESONIDE", "strength": ".25 mg/2mL"}], "application_number": "ANDA077519", "marketing_category": "ANDA", "marketing_start_date": "20190111", "listing_expiration_date": "20261231"}