dexamethasone

Generic: dexamethasone

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dexamethasone
Generic Name dexamethasone
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

dexamethasone 4 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-534
Product ID 72789-534_4589a128-79eb-aa64-e063-6294a90a953b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218372
Listing Expiration 2026-12-31
Marketing Start 2025-11-21

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 72789534
Hyphenated Format 72789-534

Supplemental Identifiers

RxCUI
197582
UPC
0372789534954
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 ANDA218372 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (72789-534-01)
  • 28 TABLET in 1 BOTTLE, PLASTIC (72789-534-28)
  • 1000 TABLET in 1 BOTTLE, PLASTIC (72789-534-95)
source: ndc

Packages (3)

72789-534-01 100 TABLET in 1 BOTTLE, PLASTIC (72789-534-01) 72789-534-28 28 TABLET in 1 BOTTLE, PLASTIC (72789-534-28) 72789-534-95 1000 TABLET in 1 BOTTLE, PLASTIC (72789-534-95)

Ingredients (1)

dexamethasone (4 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": "4589a128-79eb-aa64-e063-6294a90a953b", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0372789534954"], "unii": ["7S5I7G3JQL"], "rxcui": ["197582"], "spl_set_id": ["a8d6792e-757e-4dc6-adf5-0d9211075428"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (72789-534-01)", "package_ndc": "72789-534-01", "marketing_start_date": "20251121"}, {"sample": false, "description": "28 TABLET in 1 BOTTLE, PLASTIC (72789-534-28)", "package_ndc": "72789-534-28", "marketing_start_date": "20251209"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE, PLASTIC (72789-534-95)", "package_ndc": "72789-534-95", "marketing_start_date": "20251121"}], "brand_name": "DEXAMETHASONE", "product_id": "72789-534_4589a128-79eb-aa64-e063-6294a90a953b", "dosage_form": "TABLET", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "72789-534", "generic_name": "DEXAMETHASONE", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DEXAMETHASONE", "active_ingredients": [{"name": "DEXAMETHASONE", "strength": "4 mg/1"}], "application_number": "ANDA218372", "marketing_category": "ANDA", "marketing_start_date": "20251121", "listing_expiration_date": "20261231"}