budesonide

Generic: budesonide

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

Drug Facts

Product Profile

Brand Name budesonide
Generic Name budesonide
Labeler amneal pharmaceuticals llc
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

budesonide 3 mg/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-778
Product ID 65162-778_ef5a72fa-15a8-427d-83c5-74190a22ecd3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206200
Listing Expiration 2026-12-31
Marketing Start 2017-09-15

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 65162778
Hyphenated Format 65162-778

Supplemental Identifiers

RxCUI
1244214
UPC
0365162778304
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 ANDA206200 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 3 mg/1
source: ndc
Packaging
  • 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65162-778-10)
  • 180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65162-778-18)
  • 300 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65162-778-30)
  • 21 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65162-778-49)
source: ndc

Packages (4)

65162-778-10 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65162-778-10) 65162-778-18 180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65162-778-18) 65162-778-30 300 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65162-778-30) 65162-778-49 21 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65162-778-49)

Ingredients (1)

budesonide (3 mg/1)

Linked Drug Pages (1)

Budesonide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ef5a72fa-15a8-427d-83c5-74190a22ecd3", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0365162778304"], "unii": ["Q3OKS62Q6X"], "rxcui": ["1244214"], "spl_set_id": ["b15102d5-7884-44ed-8340-046d7b516fa8"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65162-778-10)", "package_ndc": "65162-778-10", "marketing_start_date": "20170915"}, {"sample": false, "description": "180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65162-778-18)", "package_ndc": "65162-778-18", "marketing_start_date": "20170915"}, {"sample": false, "description": "300 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65162-778-30)", "package_ndc": "65162-778-30", "marketing_start_date": "20170915"}, {"sample": false, "description": "21 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65162-778-49)", "package_ndc": "65162-778-49", "marketing_start_date": "20170915"}], "brand_name": "Budesonide", "product_id": "65162-778_ef5a72fa-15a8-427d-83c5-74190a22ecd3", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "65162-778", "generic_name": "Budesonide", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Budesonide", "active_ingredients": [{"name": "BUDESONIDE", "strength": "3 mg/1"}], "application_number": "ANDA206200", "marketing_category": "ANDA", "marketing_start_date": "20170915", "listing_expiration_date": "20261231"}