budesonide inhalation suspension

Generic: budesonide

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

Drug Facts

Product Profile

Brand Name budesonide inhalation suspension
Generic Name budesonide
Labeler cipla usa inc.
Dosage Form INHALANT
Routes
ORAL
Active Ingredients

budesonide .5 mg/2mL

Manufacturer
Cipla USA Inc.

Identifiers & Regulatory

Product NDC 69097-319
Product ID 69097-319_58158207-1901-422d-8d42-323dab348a01
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205710
Listing Expiration 2027-12-31
Marketing Start 2017-11-16

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 69097319
Hyphenated Format 69097-319

Supplemental Identifiers

RxCUI
252559 349094 351109
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 suspension (source: ndc)
Generic Name budesonide (source: ndc)
Application Number ANDA205710 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/2mL
source: ndc
Packaging
  • 30 POUCH in 1 CARTON (69097-319-53) / 1 AMPULE in 1 POUCH (69097-319-32) / 2 mL in 1 AMPULE
  • 6 POUCH in 1 CARTON (69097-319-87) / 5 AMPULE in 1 POUCH (69097-319-86) / 2 mL in 1 AMPULE
source: ndc

Packages (2)

69097-319-53 30 POUCH in 1 CARTON (69097-319-53) / 1 AMPULE in 1 POUCH (69097-319-32) / 2 mL in 1 AMPULE 69097-319-87 6 POUCH in 1 CARTON (69097-319-87) / 5 AMPULE in 1 POUCH (69097-319-86) / 2 mL in 1 AMPULE

Ingredients (1)

budesonide (.5 mg/2mL)

Linked Drug Pages (1)

Budesonide Inhalation Suspension ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "58158207-1901-422d-8d42-323dab348a01", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["Q3OKS62Q6X"], "rxcui": ["252559", "349094", "351109"], "spl_set_id": ["c52c5382-1400-44b9-95be-a30e1cf706da"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Cipla USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 POUCH in 1 CARTON (69097-319-53)  / 1 AMPULE in 1 POUCH (69097-319-32)  / 2 mL in 1 AMPULE", "package_ndc": "69097-319-53", "marketing_start_date": "20200410"}, {"sample": false, "description": "6 POUCH in 1 CARTON (69097-319-87)  / 5 AMPULE in 1 POUCH (69097-319-86)  / 2 mL in 1 AMPULE", "package_ndc": "69097-319-87", "marketing_start_date": "20171116"}], "brand_name": "Budesonide Inhalation Suspension", "product_id": "69097-319_58158207-1901-422d-8d42-323dab348a01", "dosage_form": "INHALANT", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "69097-319", "generic_name": "Budesonide", "labeler_name": "Cipla USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Budesonide", "brand_name_suffix": "Inhalation Suspension", "active_ingredients": [{"name": "BUDESONIDE", "strength": ".5 mg/2mL"}], "application_number": "ANDA205710", "marketing_category": "ANDA", "marketing_start_date": "20171116", "listing_expiration_date": "20271231"}