budesonide

Generic: budesonide

Labeler: equate (wal-mart stores, inc.) (see also wal-mart inc)
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name budesonide
Generic Name budesonide
Labeler equate (wal-mart stores, inc.) (see also wal-mart inc)
Dosage Form SPRAY, METERED
Routes
NASAL
Active Ingredients

budesonide 32 ug/1

Manufacturer
EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)

Identifiers & Regulatory

Product NDC 49035-703
Product ID 49035-703_fce82ec5-1379-4faa-a710-f989c6c9ca5a
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA078949
Listing Expiration 2026-12-31
Marketing Start 2025-07-01

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 49035703
Hyphenated Format 49035-703

Supplemental Identifiers

RxCUI
1797929
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 ANDA078949 (source: ndc)
Routes
NASAL
source: ndc

Resolved Composition

Strengths
  • 32 ug/1
source: ndc
Packaging
  • 1 BOTTLE, SPRAY in 1 BOTTLE, SPRAY (49035-703-01) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY
source: ndc

Packages (1)

49035-703-01 1 BOTTLE, SPRAY in 1 BOTTLE, SPRAY (49035-703-01) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY

Ingredients (1)

budesonide (32 ug/1)

Linked Drug Pages (1)

Budesonide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["NASAL"], "spl_id": "fce82ec5-1379-4faa-a710-f989c6c9ca5a", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["Q3OKS62Q6X"], "rxcui": ["1797929"], "spl_set_id": ["d9ba3859-90af-0390-11be-c04834e27d61"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, SPRAY in 1 BOTTLE, SPRAY (49035-703-01)  / 120 SPRAY, METERED in 1 BOTTLE, SPRAY", "package_ndc": "49035-703-01", "marketing_start_date": "20250701"}], "brand_name": "Budesonide", "product_id": "49035-703_fce82ec5-1379-4faa-a710-f989c6c9ca5a", "dosage_form": "SPRAY, METERED", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "49035-703", "generic_name": "Budesonide", "labeler_name": "EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Budesonide", "active_ingredients": [{"name": "BUDESONIDE", "strength": "32 ug/1"}], "application_number": "ANDA078949", "marketing_category": "ANDA", "marketing_start_date": "20250701", "listing_expiration_date": "20261231"}