budesonide

Generic: budesonide

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

Drug Facts

Product Profile

Brand Name budesonide
Generic Name budesonide
Labeler zydus pharmaceuticals usa inc.
Dosage Form CAPSULE, COATED PELLETS
Routes
ORAL
Active Ingredients

budesonide 3 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-720
Product ID 68382-720_08f8aa4f-4543-46d3-91f7-ae943f455648
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206134
Listing Expiration 2026-12-31
Marketing Start 2017-06-08

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 68382720
Hyphenated Format 68382-720

Supplemental Identifiers

RxCUI
1244214
UPC
0368382720016
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 ANDA206134 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 3 mg/1
source: ndc
Packaging
  • 100 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-720-01)
  • 500 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-720-05)
  • 30 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-720-06)
  • 1000 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-720-10)
  • 90 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-720-16)
  • 10 BLISTER PACK in 1 CARTON (68382-720-77) / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK (68382-720-30)
source: ndc

Packages (6)

68382-720-01 100 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-720-01) 68382-720-05 500 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-720-05) 68382-720-06 30 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-720-06) 68382-720-10 1000 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-720-10) 68382-720-16 90 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-720-16) 68382-720-77 10 BLISTER PACK in 1 CARTON (68382-720-77) / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK (68382-720-30)

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": "08f8aa4f-4543-46d3-91f7-ae943f455648", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0368382720016"], "unii": ["Q3OKS62Q6X"], "rxcui": ["1244214"], "spl_set_id": ["29863154-5f98-410e-9bf3-0f08b551edef"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-720-01)", "package_ndc": "68382-720-01", "marketing_start_date": "20170608"}, {"sample": false, "description": "500 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-720-05)", "package_ndc": "68382-720-05", "marketing_start_date": "20170608"}, {"sample": false, "description": "30 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-720-06)", "package_ndc": "68382-720-06", "marketing_start_date": "20170608"}, {"sample": false, "description": "1000 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-720-10)", "package_ndc": "68382-720-10", "marketing_start_date": "20170608"}, {"sample": false, "description": "90 CAPSULE, COATED PELLETS in 1 BOTTLE (68382-720-16)", "package_ndc": "68382-720-16", "marketing_start_date": "20170608"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (68382-720-77)  / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK (68382-720-30)", "package_ndc": "68382-720-77", "marketing_start_date": "20170608"}], "brand_name": "budesonide", "product_id": "68382-720_08f8aa4f-4543-46d3-91f7-ae943f455648", "dosage_form": "CAPSULE, COATED PELLETS", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "68382-720", "generic_name": "budesonide", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "budesonide", "active_ingredients": [{"name": "BUDESONIDE", "strength": "3 mg/1"}], "application_number": "ANDA206134", "marketing_category": "ANDA", "marketing_start_date": "20170608", "listing_expiration_date": "20261231"}