dexamethasone

Generic: dexamethasone

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

Drug Facts

Product Profile

Brand Name dexamethasone
Generic Name dexamethasone
Labeler bionpharma inc.,
Dosage Form TABLET
Routes
ORAL
Active Ingredients

dexamethasone 2 mg/1

Manufacturer
Bionpharma Inc.,

Identifiers & Regulatory

Product NDC 69452-276
Product ID 69452-276_2f9d9872-68d7-cdc2-e063-6294a90a6463
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217538
Listing Expiration 2026-12-31
Marketing Start 2023-08-01

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 69452276
Hyphenated Format 69452-276

Supplemental Identifiers

RxCUI
197581
UNII
7S5I7G3JQL
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 dexamethasone (source: ndc)
Generic Name dexamethasone (source: ndc)
Application Number ANDA217538 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (69452-276-20)
source: ndc

Packages (1)

69452-276-20 100 TABLET in 1 BOTTLE (69452-276-20)

Ingredients (1)

dexamethasone (2 mg/1)

Linked Drug Pages (1)

Dexamethasone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2f9d9872-68d7-cdc2-e063-6294a90a6463", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["7S5I7G3JQL"], "rxcui": ["197581"], "spl_set_id": ["401ec088-984a-49ab-b317-747c2b9b9e22"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Bionpharma Inc.,"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (69452-276-20)", "package_ndc": "69452-276-20", "marketing_start_date": "20230801"}], "brand_name": "Dexamethasone", "product_id": "69452-276_2f9d9872-68d7-cdc2-e063-6294a90a6463", "dosage_form": "TABLET", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "69452-276", "generic_name": "Dexamethasone", "labeler_name": "Bionpharma Inc.,", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dexamethasone", "active_ingredients": [{"name": "DEXAMETHASONE", "strength": "2 mg/1"}], "application_number": "ANDA217538", "marketing_category": "ANDA", "marketing_start_date": "20230801", "listing_expiration_date": "20261231"}