budesonide inhalation

Generic: budesonide inhalation

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

Drug Facts

Product Profile

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

budesonide .5 mg/2mL

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-984
Product ID 68180-984_3315e8ee-f729-4dab-86e4-349ab1c9c9ca
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210897
Listing Expiration 2026-12-31
Marketing Start 2019-05-21

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 68180984
Hyphenated Format 68180-984

Supplemental Identifiers

RxCUI
351109
UPC
0368180984054
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 inhalation (source: ndc)
Application Number ANDA210897 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • .5 mg/2mL
source: ndc
Packaging
  • 6 POUCH in 1 CARTON (68180-984-30) / 5 AMPULE in 1 POUCH / 2 mL in 1 AMPULE
source: ndc

Packages (1)

68180-984-30 6 POUCH in 1 CARTON (68180-984-30) / 5 AMPULE in 1 POUCH / 2 mL in 1 AMPULE

Ingredients (1)

budesonide (.5 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": "3315e8ee-f729-4dab-86e4-349ab1c9c9ca", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0368180984054"], "unii": ["Q3OKS62Q6X"], "rxcui": ["351109"], "spl_set_id": ["944cbb7c-b41d-4a6d-8a93-2e646365c982"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 POUCH in 1 CARTON (68180-984-30)  / 5 AMPULE in 1 POUCH / 2 mL in 1 AMPULE", "package_ndc": "68180-984-30", "marketing_start_date": "20190521"}], "brand_name": "budesonide inhalation", "product_id": "68180-984_3315e8ee-f729-4dab-86e4-349ab1c9c9ca", "dosage_form": "SUSPENSION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "68180-984", "generic_name": "budesonide inhalation", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "budesonide inhalation", "active_ingredients": [{"name": "BUDESONIDE", "strength": ".5 mg/2mL"}], "application_number": "ANDA210897", "marketing_category": "ANDA", "marketing_start_date": "20190521", "listing_expiration_date": "20261231"}